Instant Science

"Hacker Group" Anonymous

2010-12-13T02:53:00.000+01:00

The recent operations against Wikileak opponents and anti-piracy organizations have brought Anonymous back into the media spotlight. However, it seems that many journalists do not understand the nature of Anonymous and its structure (or absence thereof). They frequently use the term "Hacker Group", but this is actually not right.

I would prefer the term "Fluid Organization" to describe Anonymous. A fluid organization is constantly evolving with regard to its structure and its members. There are no clear borders, no defined hierarchies. Instead, its members temporarily organize around a task or cause at hand, and the temporary structure is abandoned, once the objective has been achieved.

Any comments, or better ideas on the topic?

What is a project charter good for?

2010-11-11T22:36:00.001+01:00

A project charter issued by senior management formally authorizes the initiation of a project and gives the project manager authority to apply organizational resources to project activities and tasks. It includes a description of business needs and how the project will address those needs.
Though limited to a high-level overview in its initial form, the charter should provide sufficient detail to perform the actions or reference a separate business case that has the following:

Shows alignment to enterprise strategy, goals and priorities
Illustrates how the project deliverable will meet specific business requirements
Establishes clear success criteria based on measures of client satisfaction
Identifies funding sources and high-level costs
Identifies qualitative benefits and translates to quantitative measures
Establishes appropriate interval(s) for updated cost estimates
Examines assumptions (such as system performance or skills needed)
Identifies risks and prepares mitigations
Factors risks against cost and benefit
Selects the project's guiding principles and methodologies
Communicates control mechanisms to stakeholder

Freedom of speech

2010-09-29T21:07:00.000+02:00

The well known Iranian blogger Hossein Derakhshan has been sentenced to 19.5 years in prison and a financial fine. And for what? For exercising his right to freedom of speech.

For many years, he has criticized the Iranian regime. In recent years, he has been rather positive to the regime. However, no matter if he likes the Iranian government or not and if anybody agrees to his opinion, sending him to jail for expressing it is plain wrong!

Remember Henry Fayol?

2010-09-17T12:40:00.003+02:00

In my previous post, I referred to a paper by the Institute of Strategic Studies at the United States Army War College (Unity of Command in Afghanistan: A forsaken principle of war). Here is the feedback I provided on the paper:

Unity of command is one of the 14 principles of management defined by Henry Fayol. It has been a basic principle in organization design for a long time, and has been debated controversially. Concepts such as matrix, process-, or network-organizations have been proposed as more agile alternatives. However, when it comes to military organizations, those (post-)modern approaches seem to have clear limitations. The paper demonstrates that lack of unity of command in the Afghanistan theater is one road block to success. The conclusion, to rectify command and control structures and re-focus on unity of command seems evident. Maybe, also some other principles that Fayol defined should be remembered, such as Unity of Drection.

Just as a reminder ... Here are the 14 principles of management as defined by Henry Fayol:

Division of work. This principle is the same as Adam Smith's 'division of labour'. Specialisation increases output by making employees more efficient.
Authority. Managers must be able to give orders. Authority gives them this right. Note that responsibility arises wherever authority is exercised.
Discipline. Employees must obey and respect the rules that govern the organisation. Good discipline is the result of effective leadership, a clear understanding between management and workers regarding the organisation's rules, and the judicious use of penalties for infractions of the rules.
Unity of command. Every employee should receive orders from only one superior.
Unity of direction. Each group of organisational activities that have the same objective should be directed by one manager using one plan.
Subordination of individual interests to the general interest. The interests of any one employee or group of employees should not take precedence over the interests of the organisation as a whole.
Remuneration. Workers must be paid a fair wage for their services.
Centralisation. Centralisation refers to the degree to which subordinates are involved in decision making. Whether decision making is centralised (to management) or decentralised (to subordinates) is a question of proper proportion. The task is to find the optimum degree of centralisation for each situation.
Scalar chain. The line of authority from top management to the lowest ranks represents the scalar chain. Communications should follow this chain. However, if following the chain creates delays, cross-communications can be allowed if agreed to by all parties and superiors are kept informed.
Order. People and materials should be in the right place at the right time.
Equity. Managers should be kind and fair to their subordinates.
Stability of tenure of personnel. High employee turnover is inefficient. Management should provide orderly personnel planning and ensure that replacements are available to fill vacancies.
Initiative. Employees who are allowed to originate and carry out plans will exert high levels of effort.
Esprit de corps. Promoting team spirit will build harmony and unity within the organisation.

After all, for a military organization, that doesn't sound too bad, does it?

Organizational mess - the SOF case (unclassified)

2010-09-14T14:39:00.036+02:00

I have been interested in issues in multi-dimensional organizational structures for quite a while. The problems related to matrix-style organizations, such as the inherent conflict between the two dimensions (LoB vs projects), are well known to organizational researchers and practitioners alike.

Basically, a matrix organization is a project-type structure that is superimposed on a functional structure. It is often used in organizations where certain expertise must be grouped for complex short- or long-term projects. Teams are formed with staff assigned from functional units, and when the initiative is complete, people would return to their respective groups.

The idea of the matrix organization is to maintain the characteristics of classical design (division of labor, centralization of authority, unity of control, and unity of direction) while adding the flexibility to work on critical projects. However, using a matrix approach might render conflicts between the different dimensions and these conflicts might include disputes about budgets and funding, authority, control, and accountability. And things get worse, if there are not only 2 dimensions, but even more, thus turning the matrix into a n-dimensional vector.

This can be exemplified by the United Combatant Commands (UCCs) in the US Armed Services. A UCC is a joint military command consisting of forces from two or more service branches (Air Force, Army, Navy, Marines). The purpose of establishing UCCs was to provide a more effective command and control structure where coordination and collaboration across branches was required either at functional or geographical level. Consequently, UCCs can have a geographical (AFRICOM, EUCOM, CENTCOM, ...) or functional (STRATCOM, SOCOM, TRANSCOM) focus. The UCCs also report directly to the JCS (Joint Chiefs of Staff), and not into any of the branches' command structures. A special role is played by SOCOM (Special Operation Command), which is the only UCC with acquisition authorities.

USSOCOM oversees the training, doctrine, and equipping of all U.S. SOF (Special Operations Forces) units and was established in 1986/87 in response to concerns about the status of SOF within defense planning. In particular, the experiences from operational shortcomings due to lack of coordination between SOF units from different services and the potential funding conflicts between SOFs and regular forces within the services resulted in Congressional measures to strengthen the SOF position. USSOCOM is headquartered at MacDill Air Force Base in Tampa, FL. USSOCOM has approximately 54,000 active duty, Reserve and National Guard Soldiers, Sailors, Airmen, Marines and Department of Defense (DOD) civilians assigned to the headquarters, its four components and one sub-unified command, and has an annual budget of ~8.5 b$. (Source: SOCOM presentation)

SOCOM command structure As depicted above, SOCOM has four subordinated commands that comprise the SOFs coming from the different branches (AFSOC - Air Force, ASOC - Army, NAVSOC - Navy, MARSOC - Marines) and a joint subcommand (JSOC), containing the so called special mission units (SMUs), most notably Army 1st SPF Operational Detachment Delta (aka Delta Force or Combat Applications Group) and DEVGRU (Naval Special Special Warfare Development Group). In addition, there are regional Special Operations Commands attached to the regional UCCs (e.g. SOCEUR - Special Operations Command Europe attached to EUCOM - European Command). This means, in peacetime there are three dimensions to the organizational structure of SOCOM: The SOCOM internal command structure, the regional UCCs, and the service branches. This already brings up a variety of questions, such as:

Are SOFs that are located in specific regions under the primary command of SOCOM or the regional UCC?
How are commands over CJSOTFs (Combined Joint Special Operations Task Forces, i.e. SOF Task Forces with members from different branches) distributed to give each branch a "fair share" of the available commands and related promotion opportunities?
How can it be ensured that SOF capabilities within the different service components do not overlap, but are developed in a complementary way?

These kinds of issues are debatable and in peacetime, they are interesting topics for meetings. However, if theater operations are taken into account, they are becoming critical to operational success. Considering that there are additional theater specific command structures, as seen in Afghanistan with the CFSOCC-A (Combined Forces Special Operations Component Command) and the CJOSTF-A (Combined Joint Operations Task Force), there are four dimensions to the SOF organizational structure.

Four dimensions influencing SOF in Afghanistan

The above graphic does not take into account the fact that SOFs might need to coordinate with other, non-SOFs, and coalition forces and commands at theater level.

It seems obvious that, with this kind of multi-dimensional structure, it becomes increasingly difficult to set-up clear command and control (C2) structure and to establish operational efficiency and effectiveness.

BTW, the Strategies Studies Institute has published an interesting article on the problem of unified command structures, or rather the lack thereof, in Afghanistan. I had no knowledge of this paper when I wrote this post, but obviously the author has similar concerns. You can find it here: Unity of Command in Afghanistan: A forsaken principle of war.

Total Value of IT

2009-05-18T14:38:00.004+02:00

Together with a team of franchising organizations, Gartner and itSMF (IT Service Management Forum) are offering a product under the name of TVIT - Total Value of IT. The aim is to allow clients to quickly assess their IT costs with a focus on Service Management. The concept is straightforward and simple:

An assessment of Service Management process maturity is combined with a high level IT cost analysis and peer group comparison. On the basis of the analysis, potential gaps are identified and measures to close them identified. The initial analysis and gap identification is performed in a short-term-project at moderate cost.

If you want to know more please let me know, or get in touch with the itSMF.

Lead Work Area

2009-05-12T11:24:00.003+02:00

I saw the following sign recently. Guess where ... Yes, a shooting range. I believe that there might be some lead around ... especially the flying lead can harm your health considerably.

But seriously, I can't remember having seen any warning sign like this at our shooting ranges during my army time. Was that no concern back then?

IT Cost Containment

2009-04-10T01:20:00.005+02:00

Over the past months, driven by the economic crisis, cost containment and reduction has become a major topic. Also the CIO business expectations for 2009 indicate that cost containment is on the rise. Improving business processes has been the #1 priority since 2006, but for 2009, rank 2 and 3 are occupied by cost reduction and workforce effectiveness.

This is also reflected in our client interactions, where cost reduction measures have become a frequent discussion topic. We therefore developed an approach to quickly identify savings potentials on the basis of comparing a reduced set of key metrics of a client organization with peer group data. A significant deviation will not reveal causal relations and automatically define the right measures to address the issue, but it provides an indicator which areas should be subject to a more detailed analysis and maybe a sub-sequent full-blown cost reduction program.

The following pic provides an overview of the complete approach:

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Project Portfolio Management

2009-01-21T14:15:00.002+01:00

Due to the current macro-economic situation, many companies are currently reviewing their project portfolios and realize that there might be some dead wood. Is this something to be puzzled about? Not really.

Over the past years, many organizations have become quite good at improving their development and service management processes by applying frameworks and standards like ITIL and ISO XXXX. But, for demand management and project portfolio management, being crucial processes prior to development and operations, there are no real standards or generally accepted best practices. As a result, we frequently see practices that have a significant potential for improvement (to put it carefully) and project portfolios with no or loose governance.

And, many organizations seem to have mental problem with discontinuing projects that do not deliver adequate business value - either because they do no know, or they do not have the guts.

well, I think this will change!

Tax-payers' commemoration day 2008

2008-07-11T12:38:00.003+02:00

Three day ago, on July 8, German tax payers could celebrate this year's commemoration day, i.e. from that day on they work for their own pocket and not for the government and social security.

Last year, this remarkable day was July 13, so there has been some improvement (of course, this depends on whom you ask). Nevertheless, it is astonishing that you have to work more than 6 months before you can reap and keep the benefits.

Telekom: Issue resolved

2008-07-07T09:55:00.005+02:00

My issue with Telekom regarding the upgrade of my DSL connection was resolved to my fullest satisfaction. The story unfolded like this:
dsl-upgrade-disappointed-by-telekom
instant-science-dsl-upgrade.html
About two weeks after the letter from Telekom's Board of Management support, I received a call, telling me that they had taken the following measures:

For the router invoice, a credit voucher had been issued.

The law firm had been contacted to withdraw their claim

When returning home from my business trip later that week, I indeed had a credit voucher and a letter from the law form in my mail box. So, nothing more to say from my side.

Follow-up: DSL upgrade - Disappointed by Telekom

2008-05-30T22:50:00.003+02:00

In a previous post (Instant Science: DSL upgrade - Disappointed by Telekom) I expressed my disappointment with Deutsche Telekom. Well, my mood didn't get better when I received a letter from a lawyer that claimed around 34 € in the name of Deutsche Telekom, but without actually explaining where this amount comes from and how it is composed. I assume that this is rather irregular from a legal perspective.

Consequently, I sent a letter to the law firm, asking for proof that he actually acted in the name of Telekom and also requiring a more detailed explanation of the claim. Some research on the net also indicated that the law firm is well-known, maybe one could say notorious, for its behavior. There seem to be thousands of complaints in various blogs and forums. Just search for "Seiler & Kollegen" and you will be surprised.

And, since I really was in a good mood, I also wrote a letter of complaint to Mr. Timotheus Höttges. Mr. Höttges is member of the board of management of Deutsche Telekom and also responsible for T-Home and Sales & Service. I am really looking forward to receiving a reply.

UPDATE 05-06-08

I received a reply to my letter to Mr. Höttges, Deutsche Telekom's BoM member being responsible for Sales and Service. The letter came from the BoM support unit and promised that the complaint would be forwarded to the appropriate specialists who would get in touch with me.

From the law firm I haven't received any response so far.

I am looking forward to the further proceeding ...

EU - List of restricted handluggage items

2008-05-30T22:33:00.002+02:00

I received a reply from the EASA (see below). It declares that the list of forbidden items is not within the responsibility of the EASA and asks me to contact the European Commission instead. Of course, I have already done this. Once again, I am waiting for an answer.

Sehr geehrter Herr Simon,

bitte entschuldigen Sie die verspätete Antwort. Leider müssen wir Sie auch bitten, sich damit an die Europäische Kommission, Generaldirektion Verkehr zu wenden, da die Liste der verbotenen Gegenstände nicht in den Aufgabenbereich der EASA fällt. Sie können Ihre Frage an TREN-AIR-TRANSPORT@ec.europa.eu senden.

Mit freundlichen Grüßen

EASA Communications Department

EU - List of restricted handluggage items

2008-04-22T10:26:00.002+02:00

The EASA (European Aviation Safety Agency) issued a list of restricted handluggage items (Directive 68/2004) on February 1, 2004. The list contains a considerable number of items which obviously make little sense in an airplane, such as explosives, guns, etc.

However, there are also some items that confused me. Why should a golf club be harmful? Have you ever tried to swing a golf club in an airplane? think it might be difficult to use it as an effective weapon.

The list also contains martial arts equipment and list some examples, such as shuriken and nunchakus, and kubatons. However, it also contains an item called "kubasaunt" and honestly, spoken, I have no idea what this might be. I am tempted to believe that the EASA doesn't know either and the term just ended up there as the result of a mistake. Consequently, I sent the following note to the EASA, asking for a clarification:

Sehr geehrte Damen und Herren,

in Ihrer Verordnung EG 68/2004 vom 01.02.2004 werden Gegenstände aufgelistet, deren Verbringung in ein Flugzeug aus Gründen der Flugsicherheit nicht zulässig ist.

Unter Abschnitt 1 - Punkt 3 (Stumpfe Gegenstände) werden auch Kampfsportausrüstungsgegenstände aufgeführt, darunter „Kubasaunts“.

Dieser Gegenstand ist mir, im Gegensatz zum ebenfalls genannten Kubaton, unbekannt. Bitte teilen Sie mir mit, was ein Kubasaunt ist, damit ich nicht unversehens in die Situation komme, ein solches eventuell bei einer Reise mit mir zu führen.

Mit freundlichen Grüssen,

Kai Simon

If you also are curious what kubasaunts are, check back later. I'll post the answer from EASA here.

DSL upgrade - Disappointed by Telekom

2008-04-03T10:28:00.003+02:00

At home, I have a DSL connection provided by Telekom since 2001. Until February this year, I had a 6 mbit connection with DSL and phone flatrate and I virtually never had any problem with regard to availability. The cost was maybe somewhat higher than with some competitors, but the service lovel made me stay.

Then I was called by a customer representative and offered an upgrade from 6 -> 16 mbit, in combination with a hotspot flatrate. The flipside was a 2 year contractual obligation, but I considered this as acceptable.

A few days later I received the order conformation and another couple of days later the DSL connection was dead. When calling the service center I had to learn that my DSL modem was not capable of a 16 mbit connection and that I would need a new one at the cost of 49 €. I was also told that the cost could be offset against my monthly fee, since I had not been informed about the additional cost.

A few days later, I received the new modem that nowadays is combined with a wireless access point, installed it and functionality was thus restored. I then sent a mail to Telekom customer service, told them about the issue and asked how to handle the refund/offset. I also told them that I would not pay the invoice for the port, until the issue was settled.

Today, I received a call where I was told that a refund or offset is out of question and that I should pay the invoice. The reason given was that 49 € is the price and since they could not confirm that I had not been informed about the fact that I would need a new port, there was no reason to waive the invoice.

I then tried to revoke the upgrade. No, this wasn't possible either since the cancellation period is two weeks. This despite the fact that I had contacted them regarding the issue within this period and the handling time caused the delay.

Well, what I am supposed to do now? Probably send a harsh letter to Telekom manangement, try to enforce the revocation of the contract and then change the provider. So far, my impression of Telekom's service offering has been positive, but this has really disappointed me.

Ministerial Fingerprint

2008-03-29T23:12:00.003+01:00

In the latest version of the Datenschleuder, the Chaos Computer Club (CCC) has published a fingerprint of Germany's Minister of the Interior, Wolfgang Schäuble. It also contains an instruction how to make fake fingerprint that can be attached to another person's fingertip.

The CCC has been fighting authorities' data acquisitiveness for quite some time now, and this scoop will hopefully fuel this discussion and make a broader audience aware of what threat to personal integrity the widespread use of biometrical data constitutes.

BTW, this is the fingerprint:

Data retention law - Vorratsdatenspeicherung - Slap in the face for government

2008-03-19T21:59:00.007+01:00

Today, the German constitutional court issued an intermediate decision regarding the new data retention law. The law forces telcos and ISPs to store any connection data for six months and to make it available to law enforcement organisations (police, prosecutors) upon request. The court has ruled that this data only needs to be made available in the case of capital crimes. The final decision is expected to be taken later this year.

Some time ago, the German Minister of Justice commissioned an investigation regarding the legal aspects of the planned data retention law. Obviously, the result was not the desired one and the publication has been slowed for quite some time, while requests regarding the publication of an intermediate version have been refused by the ministry.

It is astonishing, how frequently the "law and order" politicians in the German government are slapped by the constitutional court. Last week, the court prohibited the automated scanning of cars' license plates, this week the next slap in the face.

Addition (March 21, 2008): One of the best commentaries on the topic I found, in the paper "Die Zeit".

Computerwoche article

2008-03-17T19:05:00.003+01:00

I recently published a short article on the "Glocalization of IT Governance" in the German IT weekly Computerwoche. It outlines four governance styles and describe their main characteristics.

If you read German, you can find it here.

Feedback and comments are welcome!

Conference presentation

2008-03-07T21:30:00.003+01:00

On June 4, I will be giving a keynote presentation on Enterprise Information Management (EIM) at a conference arranged by IIR. When starting to prepare the keynote I realized that the term EIM is used in a rather inconsistent way by users and vendors alike. But, as some of my colleagues stated: for companies to manage their information assets better, they need to clearly understand the term enterprise information management and its meaning. And, they also came up with a definition:

Enterprise information management (EIM) is an integrative discipline for structuring, describing and governing information assets, regardless of organizational and technological boundaries, to improve operational efficiency, promote transparency and enable business insight.

This definition is comprehensive and covers the most important elements of EIM. But, although it is a one sentence definition, I was looking for something even shorter. How do you like this one:

EIM is the just-in-time concept for information.

Unfortunately, the conference was cancelled due to a small number of participants. I find it interesting that a concept like EIM is not interesting enough to attract a larger audience.

WLAN Security

2008-03-01T15:19:00.004+01:00

A lot of people still seem to be rather ignorant about the vulnerability of their wireless access points. One of our neighbors believed that using a hidden SSID would be a sufficient security level. Of course it is helpful, but if you change neither the standard SSID nor the standard password for router administration ...

Well, today is his birthday, so in the last row you can see my congratulations:

This was just for the lulz and I promise that I also will give him the new password when he comes over for a party tonight. So, no harm done.

Otherwise, security is still an underestimated issue. Imagine, I had used his access point for unlawful activities. He would have a hard time explaining this to the police.

Service Management

2008-02-14T10:55:00.004+01:00

Another ex-colleague from Altana Pharma / Nycomed got back in touch. He is now working as a consultant in the Service Management area.

That made me think about a proposal I am working on. The client has established ITIL-processes and they seem to work well, but still there are issues regarding the collaboration with the business side.

It seems that the client, and for this matter also many other organizations, has invested considerable resources in establishing Service Management processes, but mainly on the deliver side. The demand management side seems to have been largely ignored, i.e. the entire part from demand to project/service is not really covered and thus still a potential subject to misperception.

Conclusion: Proper Service Management must cover the complete process from demand generation to service delivery and not only parts of it.

Social Networking vs IRL meetings

2008-02-12T12:42:00.000+01:00

Today, I received a Xing message from a former colleague at Nycomed/Altana Pharma. It was nice, because he did not send a simple connect request, but a longer message that also contained some interesting thoughts on social networking.

This, in turn, made me think of a phenomenon I could observe over the last 2 days. My son (age 16) spend quite some time video-chatting with a female class-mate. The interesting thing is that the walking distance is just 10 minutes.

Clearly, social networking can enable reconnects with old friends. The "cheers to absent friends" might become less frequent, if you can connect them remotely. I use Skye, Facebook etc. to keep in touch.

On the other hand, social networking on the net also has a potential to change social patterns. Instead of visiting each other, we could chat or skype. This reminds me of the book Robots and Empire by Isaac Asimov, in which the human spacer branch lives more or less individually and IRL visits are kept at a minimum.

Well, regarding my son, I believe that there's no overly risk that he will totally disappear into the online world, as long as he can't sit there with his friends and have a beer. :-)

Anonymous vs Scientology - 10th Feb protests

2008-02-12T12:29:00.000+01:00

On Sunday, IRL protests took place at various CoS centers around the globe. It is difficult to say how many people actually were engaged and what impact the protests had. There are several media reports, but it is difficult to get a holistic picture. Some press coverage is collected on the German Chanology website.

When looking for some info on the protests, I stumbled upon this picture:

Source: media.de.indymedia.org

I also seems that more activities are planned for March 15.

Scientology vs Anonymous Update II

2008-01-28T11:05:00.000+01:00

The initial gun smoke has vanished. Several Scientology web sites have been under attack and grounded for some time, while others are online. At the same time, the attack on the sites, wikis and IRC channels being used for coordinating Anonymous' activities, performed under the name "The Regime", have caused them to build a new defense line. By now, this seems to work and the sites are online and by now also local ones, e.g. in Germany, have emerged.

By now, Anonymous is planning continued cyber-attacks, but also IRL activities, such as prank calls to Scientology establishments and members, and on-site demonstrations are taking place.

It should also be noted that Anonymous is not, as it has been widely reported, a group of hackers, but a loosely coupled network of people without a clear structure and governance, sharing a cause. In other words, Anonymous is structurally close to the internet itself.

This is, on the hand hand, a clear advantage. Since loosely coupled groups without central governance can operate independently and quickly regroup, taking out a node of the network will not harm the superstructure. On the other hand, they are more difficult to control and direct. In addition, Anonymous is based on the engagement of volunteers that might not be enduring.

The strength of Anonymous is therefore also its weakness. The success or failure of this campaign therefore ultimately depends on Anonymous' ability to reach and maintain a critical mass of people and keep together this loosely coupled structure.

Update on Scientology vs Anonymous: CoS striking back?

2008-01-26T10:33:00.001+01:00

Yesterday night (CET), parts of the infrastructure being used by Anonymous for information sharing and coordination suddenly came under attack. partyvan.info and 711chan became unavailable and the discussion on the IRC channel became a little chaotic for some time.

After a while, backup forums had been set up and also the sites were restored. However, at the publishing time of this post, partyvan.info is again unavailable.

Is CoS striking back with the same methods used by Anonymous?

Scientology vs Anonymous

2008-01-26T00:08:00.000+01:00

It seems, that a war has been declared on Scientology. A user has published a video on Youtube, in which group calling itself "Anonymous" (nomen est omen!) declares its will to destroy the CoS. It seems that some DDoS attacks on CoS webservers already took place. Also, the group has managed to hack some CoS servers and extract some internal documents which are now distributed via filesharing services.

Here is the video:

Here is a news feature on the topic:

When searching on Youtube you will find more vids on the topic

Here is a website/wiki maintained by Anonymous and providing information on the campaign, but also links to the before mentioned documents and software to run DDoS attacks, and more.

The original declaration ends with the following statement:

We are Anonymous.
We are Legion.
We do not forgive.
We do not forget.
Expect us.

---
My take: For the lulz?

Social Sites

2007-12-11T00:03:00.000+01:00

I wrote about that some time ago, but the issue is still highly relevant.

It has become increasingly difficult to follow the development in the social software space. Blogs, wikis, social tagging, networking sites, etc. A consolidation will surely take place over the next years but for the time being, one has to maintain a variety of profiles on different sites. Here are some of mine:

Profile on Facebook
Profile on Xing
Public profile on LinkedIn

If we assume that Web 2.0 technology will become an important of enterprise information management, corporate IT departments will have to handle a variety of challenges.

Conference on Enterprise Portals

2007-11-30T16:07:00.000+01:00

I recently gave a keynote presentation at a conference on Enterprise Portals, organized by IIR. My topic was Portals of the Future and I claimed, among other things, that Web 2.0 software would become an integral part of corporate information management. In this context, I also asked the participants whether they have accounts on social networking sites, e.g. Facebook of MySpace. It was a real surprise, when only 2 or 3 participants raised their hands. I had expected a considerably higher diffusion.

I also recommended to set up a governance structure for current and future portal initiatives and asked, whether this or a general governance already existed. Again, very few hands were raised. It seems that there is a lot of work to do.

Public profile on LinkedIn

2007-11-10T03:17:00.001+01:00

I invested some time to update my LinkedIn account: .

Occasionally I wonder, where to find the time to handle all the community and networking sites, such as Facebook, Stayfriends, etc. Could the solution be a piece of software that allows me to maintain my information for all these sites on my personal computer and that provides any change per feed to the sites where I am registered?

Data retention law - Vorratsdatenspeicherung - Freedom of speech R.I.P.

2007-11-10T01:16:00.000+01:00

Today, the German parliament passed a law on telecommunication and internet connection data retention. The law incorporates the principles of the EU Data Retention Directive, that is the mandatory retention of all telecoms traffic data for law enforcement purposes.

In brief, starting in 2008, all providers of telecommunication services and ISPs are required to store the connection data of their customers for 6 months and to make it available to law enforcement agencies upon request.

Traffic data to be stored includes a variety of information - sender and recipient of emails, phone numbers of callers and recipients for each phone call, etc. In addition, the use of anonymization services will be forbidden.

I strongly object this law, since I consider it as being an intrusion into my and other citizens privacy. I have joined a class action against the law that will be brought in front of the German constitutional court.

If you want to know, more, please click on the image below:

Back again

2007-11-10T01:09:00.000+01:00

After quite some time, I am now starting to post again here. Since my last post, I have been on holiday in Sweden, finished and begun some interesting consulting assignments, been on a short holiday in Vienna, participated in the Gartner Symposium in Cannes, just to name a few things.

So, from now on, I will try to find some more time for posting in some interesting topics here.

Tax-payers' commemoration day

2007-07-10T23:15:00.000+02:00

Today is a remarkable day. From now on, the German taxpayers salaries stay in their own pockets. Until today, the income has been absorbed by the tax- and social security systems. This year, the tax payers are allowed to keep 47% of their income, which means that commemoration day this year occurs 5 days later than last year.

Feeling better

2007-07-10T12:19:00.000+02:00

A couple of days ago, I had an interesting private discussion with some managers (no names and companies mentioned). We came to discuss about one of my favourite topics, Business Process Management

They were telling me that they had no real understanding of the business processes in their organization, but that some consultants were now doing a process analysis and mapping everything in visio files.

At that point I became a little irritated and told them that I consider it as management malpractice to be process-ignorant and that hiring consultants to paint visio-charts wouldn't make things better. Instead, they should aim for a holistic BPM approach and use a platform that is more than a painting tool. And if the consultant were not able to use other tools, the managers should ask themselves if they would trust a mechanic that would tell them that he doesn't know an allen key, but that those hexagon socket screw also could be removed with a cross recess screwdriver.

I don't know whether it had any effect, but at least I felt better afterwards.

What else is new?

2007-07-10T12:07:00.001+02:00

The article on improving clinical trials by applying business process modeling,that I have been writing with my former Nycomed colleague Mathias Poensgen is finished and sent to a journal for review. I believe that publishing a rather management science oriented article is also something new for this kind of publication, so I am curious about the review.

Well, I am also very satisfied with my new job. Interesting people, and challenging high-profile projects. The first quarter brought projects in Germany, Italy, and Sweden. Especially the latter was making me feel like home, since I also had the chance to visit some old friends in Stockholm.

Back in black ...

2007-07-10T11:59:00.001+02:00

Well, I mostly wear grey suites, but the post title is the name of an AC/DC song from 1980's album with the same name. After some pausing I will now reassume blogging. The major reason for the interruption was my recent job change back into consulting, that also elevated my work hours. Well, after knowing the way around in a new company, things tend to get a little easier again and so I think that I will find some more time for writing again.

Computerwoche article

2007-04-22T13:47:00.000+02:00

My Computerwoche article was published last week under the title: Die IT muss näher ans Business.

Any feedback is appreciated.

The first 2 weeks

2007-04-22T13:34:00.000+02:00

The first three weeks at Gartner are over. A brief summary could read like this: High workload, smart and nice colleagues, very interesting project challenges.

On my second day, after having made myself familiar with some administrative routines, I received a request for proposal from a colleague and had the chance to prove my competence in writing proposals over the next few days.

In week 2, I was casted into a rather challenging project. A client has asked for assistance in identifying a significant IT cost reduction potential. This will keep me occupied for some more weeks at a high work pace.

Last day ...

2007-03-31T23:53:00.000+02:00

Yesterday, I had my last working day at Altana/Nycomed. When I came in for the last days I heard that more than 10 people from the IT department had proactively resigned within the last week.

The massive lay-offs that are planned at the Konstanz-site are also discussed in various blogs:
Dornröschen
Südkurier

Article finished

2007-03-17T14:41:00.000+01:00

Finalized the article for Computerwoche, issue 15/2007. A link to the article will be available here as soon as it is published. I am very interested in any feedback from the readers.

Money for nothing - Update

2007-03-17T14:39:00.000+01:00

I transcribed the letter I received from the chamber of lawyers in response to my complaint about the interesting behaviour of lawyer Olaf Tank. Scroll down or follow the link in the post title.

More writing

2007-03-15T00:13:00.000+01:00

Since I am having a long vacation before joining my new employer, Gartner, I have found some more time for writing.

In a near future issues of Computerwoche I will discuss how the CIO and an internal IT department can get involved in business process improvement initiatives. The focus will be on the challenges and pre-requisites.

The other article is outlining how clinical operations can be improved by applying BPM to improve processes and systems. The target audience is clinical operations managers. This article is co-authored by Dr. Mathias Poensgen, a very knowledgable Nycomed colleague who is head of department for Clinical Operations / Systems and Processes. If you are a Xing-user, you can find him here.

Finally ...

2007-02-20T14:22:00.000+01:00

I found some time for writing and the result is going to be published in the 2007 edition of the BPM and Workflow Handbook. My chapter Business Process Management in Pharmaceutical R&D will address general aspects of BPM in a pharma environment, and also present a mini-case on BPM in clinical development in former ALTANA Pharma, now being part of the Nycomed group.

The ugly middle management?

2007-01-31T14:32:00.000+01:00

I am sitting in a conference on Business Process Management right now. Including myself, there have have been four speakers that have proposed that, in many change initiatives, it is not middel management that hampers change. On the contrary, middle management often welcomes the attempt to improve things and is close enough to the operational business to know about shortcomings and improvement potentials.

Obviously, it seems to be between executive management and middle management where you can find the roadblocks. Senior managers, stating "This is a nice idea. Why don't you go ahead and work with it? And please, don't bother me too much with this stuff in the future!"

What is this supposed to mean? Is it rejection? Not really. Is it support? Hardly. In other words, it is worth nothing, but you are decoupled from executive management.

Grand Opening

2007-01-16T21:46:00.000+01:00

Today, the new Nycomed was officially launched. The CEO delivered a short speech and removed the cover from the new "Welcome to Nycomed" sign at the entry to the Constance premises.

Formally, the new company has existed for about 2 weeks now and the integration activities have been initiated already in virtually all departments. So far, however, very little was actually communicated with regard to the future organization structure.

The integration and harmonization of the different business processes that exist within the two "old" departments is also going to be a considerable challenge. This is also outlined in this article in CIO Magazine.

Virtual BPM Conference

2007-01-10T20:28:00.000+01:00

ebizQ has started a website and blog on Business Process Management to promote a virual BPM conference, taking place on March 6-7. I am curious how the concept of a 2-day virtual conference is going to work out.

New job as of April 1

2007-01-09T11:14:00.000+01:00

It has been a long time since the last post. At the end of 2006, the take-over of my current employer was finalized. ALTANA Pharma is now a part of Nycomed.

Due to several reasons, I have decided to dis-embark from the new organization and to move back into the consulting world. As of April 1, I will join the consulting organization of GARTNER in Germany.

Private issue - Money for nothing

2006-11-27T21:24:00.001+01:00

A few days ago, I received an invoice for a service I never ordered from a website I don't even know. The letter came from a lawyer with the name of Olaf Tank in the name of a company called A & M Schmidtlein GbR. Some web research revealed, that this seems to be a scam and that those guys, in mascopy with the lawyer, have established a well-working money making machine by scaring internet-users to pay their regularly unjustified claims. There seem to be thousands of complaints and reports filed with the police and prosecution authority.

I sent the following letter (in German) to O. Tank, Esq and I also filed a complaint with the chamber of lawyers (Anwaltskammer) in Oldenburg, which is the competent chamber for Mr. Tank. For the reply, please scroll down.

---

Sehr geehrter Herr Tank,

vielen Dank für Ihr Schreiben. Ich nehme hierzu wie folgt Stellung:

Die von Ihnen genannte Web-Adresse P2P-heute.com ist mir unbekannt und wurde von mir nie besucht.

Zur Untermauerung Ihrer Forderung wollen Sie mir bitte folgende Unterlagen zusenden:

1. Nachweis der gesetzlich vorgeschriebenen Widerrufsbelehrung

2. Abschrift der versandten Rechnung, inklusive Rechnungsadresse

3. Abschrift der versandten Mahnung, inkl. Rechnungsadresse

4. Nachweis der vollständigen Anmeldungsdaten auf der Web-Site P2P-heute.com

5. Eine im Original unterschriebene Inkassovollmacht Ihrer Mandantschaft, bezogen auf die von Ihnen angegebene Rechnungsnummer

6. Nachweis des Internetproviders, dass die von Ihnen genannte Anmelde-IP zu dem von Ihnen genannten Zeitpunkt mir zugewiesen war.

Desweiteren fordere ich Sie auf, mir innerhalb von 2 Wochen offenzulegen, welche personenbezogenen Daten Sie, bzw. Ihre Mandantschaft, über meine Person gespeichert haben.

Ich behalte mir vor, rechtliche Schritte bezüglich der an mich gestellten Forderungen, sowie nach Ablauf der Ihnen gesetzten Frist wegen möglicher Verletzung des Bundesdatenschutzgesetzes, gegen Sie, bzw. Ihre Mandantschaft, einzuleiten.

Bitte geben Sie bei Ihrer Antwort stets mein Aktenzeichen an, um eine reibungslose Bearbeitung zu gewährleisten.
(Anmerkung: Ich hatte natürlich mein eigenes AZ im Betreff angegeben)

Mit freundlichen Grüssen, K.S.

---

Update Dec 3, 2006: I received an answer to my message.

---
Sehr geehrter Herr Simon,

vielen Dank für Ihre Nachricht.

Sie haben sich am 15.09.2006 auf der Seite p2p-heute.com angemeldet, ein Widerspruch ist innerhalb der gesetzlich vorgeschriebenen Frist nicht erfolgt. Die Rechnung wurde am 07.10.2006 an folgende E-Mail-Adresse: ***@web.de versendet. Ebenso die Mahnung vom 22.10.2006.

Des Weiteren hat eine Verifizierung der Anmeldung über die genannte Mailadresse stattgefunden.

Ihre Stellungnahme werten wir als Zahlungsverweigerung. Die Angelegenheit haben wir an unsere Mandantschaft weitergeleitet und werden dieser empfehlen, die Forderung gerichtlich geltend zu machen, wodurch weitere Kosten zu Ihren Lasten entstehen. In unserem Hause erklären wir die Angelegenheit als erledigt.

Mit freundlichen Grüßen, N.N.

---

I cordially replied with the following message.

---
Sehr geehrte Damen und Herren,

vielen Dank für Ihre Antwort (E-Mail) vom 01.12.06 auf mein Schreiben (E-Mail) vom 24.11.06 bezüglich Ihres Schreibens vom 22.11.06.

Meine Stellungnahme ist meines Erachtens nicht a priori als Zahlungsverweigerung zu betrachten. Ich möchte hier klarstellen, dass dies eine von Ihnen vorgenomme Interpretation ist.

Es ist jedoch für Sie sicherlich nachvollziehbar, dass ich einer Zahlungsaufforderung nicht nachkomme, ohne dass mir entsprechende Unterlagen zur Glaubhaftmachung der Forderung vorliegen.

Da Sie, nach Ihren Angaben, die Angelegenheit an Ihre Mandantschaft weitergeleitet und den Vorgang abgeschlossen haben, betrachten Sie bitte den untenstehenden Punkt 5 (Inkassovollmacht Ihrer Mandantschaft) als hinfällig. In Bezug auf eine eventuelle weitere Betreibung durch Ihre Mandantschaft fordere ich diese auf, mir die unter den u.a. Punkten 1-4 und 6 genannten Unterlagen zukommen zu lassen.

Auf Basis der Ihnen obliegenden Auskunftspflicht gemäss § 34 BDSG fordere ich Sie jedoch weiterhin auf, mir offen zu legen, welche personenbezogenen Daten über meine Person bei Ihnen gespeichert sind und aus welcher Quelle diese Daten stammen. Desweiteren untersage ich Ihnen die Weitergabe dieser Daten an Dritte. Eine Aufforderung an Sie, diese Daten zu löschen (§ 35 BDSG) behalte ich mir vor.

Mit freundlichen Grüssen, K.S.

---

A couple of days later, I indeed received a mail with the data I had requested. Since the data is public and can be found in the phone catalogue, I had no problems with it occupying some disk space there.

---

December 15, 2006: I received an answer from the chamber of lawyers in Oldenburg per letter. In the following, I have transcribed the letter in German.

---
Sehr geehrter Herr Simon,

wir bestätigen den Eingang Ihrer o.g. E-Mail.

Zu den Aufgaben der Kammer dürfen wir zunächst auf folgendes hinweisen:

Ein Rechtsanwalt ist gemäss § 43 der Bundesrechtsanwaltsverordnung (BRAO) verpflichtet, seinen Beruf gewissenhaft auszuüben. Er hat sich innerhalb und ausserhalb des Berufs der Achtung und des Vertrauens, welche die Stellung des Rechtsanwalts erfordert, würdig zu erweisen. Die Überwachung dieser Pflichten obliegt gemäss § 73 Abs. 2 Nr. 4 BRAO dem Vorstand der Rechtsanwaltskammer. Die Kammer kann nur im Rahmen dieser gesetzlichen Regelung tätig werden.

Es gehört nicht zu den Aufgaben der Rechtsanwaltskammer die Interessen einzelner Beschwerdeführer gegenüber dem Rechtsanwalt zu vertreten und deren Belange durchzusetzen. Die Kontrollfunktion dient vielmehr dem öffentlichen Interesse an einem geordneten Recht und Gesetz entsprechenden Ablauf der Rechtspflege. Die Kammer kann im Wege der Aufsicht nur tätig werden, wenn der Rechtsanwalt gegen seine Berufspflichten verstossen hat. Dabei ist sie im Hinblick auf die Stellung des Rechtsanwalts als unabhängiger Berater und Vertreter in allen Rechtsangelegenheiten (§§ 1, 3 BRAO) nicht befugt seine Handlungen auf inhaltliche Richtigkeit und Zweckmässigkeit zu überprüfen. Diese Grenzen hat die Rechtsanwaltskammer zu beachten.

Bei einem Verdachtsfall strafbaren Verhaltens steht jedem Bürger das Recht der Strafanzeige frei. Es ist die Aufabe der Strafverfolgungsbehörden, die erforderlichen Ermittlungen zu führen.

In dem vorliegenden Fall geht es im Kern um das Verhalten des Auftraggebers des Rechtsanwalts, der Firma Schmidtlein und evtl. weiterer Firmen. Es ist zunächst Aufgabe der Strafverfolgungsbehörden zu prüfen, ob das Geschäftsgebaren der Fa. Schmidtlein und evtl. weiterer Firmen und das damit verbundene Tätigwerden des Rechtsanwalts Tank einen Straftatbestand erfüllt. Deswegen hat die Rechtsanwaltskammer die Generalstaatsanwaltschaft Oldenburg unterrichtet, die nach der Bundesrechtsanwaltsodnung die Ermittlungen in anwaltsgerichtlichen Verfahren führt. Die Generalstaatsanwaltschaft hat ihrerseits die zuständige Staatsanwaltschaft unterrichtet.

Die Möglichkeiten der Rechtsanwaltskammer selbst sind damit einstweilen erschöpft. Es bleibt zunächst abzuwarten, zu welchem Ergebnis die Ermittlungen der Strafverfolgungsbehörden führen. Wird ein strafbares Verhalten festgestellt, obliegt es der Generalstaatsanwaltschaft zu prüfen, ob weitere Massnahmen, z. B. die Einleitung eines anwaltsgerichtlichen Verfahrens, in Betracht kommen.

Sie können versichert sein, dass es im Interesse des Ansehens des Berufstandes auch ein Anliegen der Kammer ist, dass der Sachverhalt von den Strafverfolgungsbehörden baldmöglichst geklärt wird. Die Kammer selbst kann aber nur in dem vorstehend beschriebenen Rahmen tätig werden.

Mit freundlichen Grüssen

(Name, Unterschrift)
Vorsitzender

Top-down process map

2006-11-20T14:38:00.000+01:00

One of my tasks is the development of a top-down overall process map at Levels 0-2. When the BPM Team started its work in September last year, there was a considerable number of process descriptions at a highly granular level, but little at medium- or top-level. As a consequence, it was rather difficult to develop a comprehensive picture of business processes that spans over various functions.

I have had several discussions with my boss regarding the mandate for developing the process map. It is my clear opinion that the development of a top-down map, starting at level 0, also requires an appropriate mandate by the executive board. Otherwise, it becomes considerably difficult to get the necessary support in the business units. I also tend to claim that this is "good practice" and after all, everybody teaches you at universities and conferences.

My boss, on the other hand, keeps telling me that this only happens in an ideal world and that we have to manage without a board decision, but that all VPs were informed about the initiative. The problem, as far as I am concerned, is that there is no requirement for an endorsement of the process map initiative from their side.

Let's see, how this develops ...

Process Models and Change Management

2006-11-17T10:49:00.000+01:00

When asking people about the importance of change management in projects where business processes and/or IT systems are changed or replaced, everybody will instantly agree that this is important. Given that this is true, how do you actually determine where change is about to take place?

If you have your as-is and to-be processes properly defined and documented, you can use the process documentation as the basis for defining the change management plan. For each role, the current and future tasks can be identified, including the use of specific IT systems to support the performance of these tasks. In a similar way, you can see which tasks are no longer required to be performed by a specific role and which ones eventually have been added.

Is this a good argument for proper process documentation?

Can we win a Nobel Prize with a CSR?

2006-11-06T22:50:00.000+01:00

Update on the post from Oct 27, 2006

The discussion regarding Safety Narratives in Clinical Study Reports is still ongoing. There are still some open question, the most important being: Does chapter 12.2.2 of the ICH E3 Guideline require an interpretative narrative, i.e. an assessment of each individual Adverse Event, similar to those in the CIOMS form?

This question boils down to the interpretation of section 12.3.2 and 12.3.3. According to my opinion, which is supported by some colleagues, it is sufficient to include a non-interpretative narrative in 12.3.2 and to have all interpretation in section 12.3.3.

In addition, the following questions also need to be addressed:

Is a review required, when the process for creating auto-generated narratives is validated?

Are all items to become part of the auto-generated narrative to be reconciled?

Here is the original text from the ICH E3 Guideline:

12.3.2 Narratives of Deaths, Other Serious Adverse Events and Certain Other Significant Adverse Events
There should be brief narratives describing each death, each other serious adverse event, and those of the other significant adverse events that are judged to be of special interest because of clinical importance. These narratives can be placed either in the text of the report or in section 14.3.3, depending on their number. Events that were clearly unrelated to the test drug/investigational product may be omitted or described very briefly. In general, the narrative should describe the following: the nature and intensity of event, the clinical course leading up to event, with an indication of timing relevant to test drug/investigational product administration; relevant laboratory measurements, whether the drug was stopped, and when; countermeasures; post mortem findings; investigator's opinion on causality, and sponsor's opinion on causality, if appropriate.
In addition, the following information should be included:

Patient identifier

Age and sex of patient; general clinical condition of patient, if appropriate

Disease being treated (if the same for all patients this is not required) with duration (of current episode) of illness

Relevant concomitant/previous illnesses with details of occurrence/duration

Relevant concomitant/previous medication with details of dosage

Test drug/investigational product administered, drug dose, if this varied among patients, and length of time administered

12.3.3 Analysis and Discussion of Deaths, Other Serious Adverse Events and Other Significant Adverse Events
The significance of the deaths, other serious adverse events and other significant adverse events leading to withdrawal, dose reduction or institution of concomitant therapy should be assessed with respect to the safety of the test drug/investigational product. Particular attention should be paid to whether any of these events may represent a previously unsuspected important adverse effect of the test drug/investigational product. For serious adverse events that appear of particular importance, it may be useful to use life table or similar analyses to show their relation to time on test drug/investigational product and to assess their risk over time.

Job in Drug Safety / Pharmacovigilance

2006-11-03T18:48:00.000+01:00

My employer, ALTANA Pharma (Nycomed from Jan 1, 2007), is looking for a Drug Safety / Pharmacovigilance associate. If you are interested, drop me a mail (or comment on this blog-post) and we will get back to you.

Processes and systems

2006-10-31T15:26:00.000+01:00

A CTMS (Clinical Trial Management System) is at the core of clinical IT landscape. It contains a wide array of master data about clinical studies and supports the organization performing the trial with tregard to managing all activities within the study.

Since the CTMS is involved in virtually all trial related processes, it also has a considerable number of interfaces. It contains the investigator and ethics committees address data which are e.g. required for sending out Dear Dr. Letters, it mirrors the site visit structure and trigger payments to investigators, etc.

When replacing a CTMS, it is thus inevitably important to invest an adequate amount of time and resources to analyze the business processes that the CTMS is supposed to support. The process analysis can then also be used to derive functional requirements for the URS.

Yesterday, I as at the kick-off for a new project, aiming at the revision of our CTMS, and it was clearly stated: First processes, then systems. Which reminds me of this:

©Far Side

I am very satisfied that this approach has become standard in our clinical development unit. Any new business project starts with a thorough process analysis and documentation. That's the way I like it!

Safety narratives in CSRs

2006-10-27T12:52:00.000+02:00

According to the ICH E3 Guideline (Structure and Content of Clinical Study Reports), each study report (CSR) must contain a section on Safety (section 12). Most of the content here are listings, but section 12.3.2 requires Narratives of Deaths, Other Serious Adverse Events and Certain Other Significant Adverse Events.

A narrative is a brief textual description of the case. An interesting question is, where the content for these narratives comes from and who is supposed to to provide or write it. This could be either the Drug Safety (Pharmacovigilance) unit, or Medical Writing. Drug Safety could argue that the basic ocntent already exists as part of the CIOMS (Council for International Organizations of Medical Sciences) forms that are used for SAE reporting (reporting of Serious Adverse Events) and that have been submitted to the authorities already. On the other hand, Medical Writing could argue that these narratives are too lengthy and elaborated and not suitable for inclusion into the CSR. In addition there might be diverging data elements, such as reference dates.

A solution might be to use the clinical database to generate the CSR Safety Narratives automatically. One could develop a standard text, which is then filled with database content. This would create narratives that all have the same "look and feel", even though they might render somewhat "mechanic" texts. There are also some advantages:

There are no more data divergence problems, since all data comes from one system. However, it should be checked whether the number of items being subject to reconciliation needs to be increased to ensure that all data being used for creating the narrative from the clinical system is consistent with the corresponding elements in the Drug Safety system.

The narratives can be kept brief and there is no need for harvesting CIOMS forms. Those could be made available to the authority upon request.

If the data extraction process is validated, there is no need for output validation of each narrative.

The narratives must not be reviewed by medical experts with regard to correctness.

If any of you has experience regarding this issue, I would really appreciate your feedback.

Reporting of Adverse Events to BfArM

2006-10-27T11:29:00.000+02:00

Sorry for mixing German and English in this post.

Over the past days, I had a discussion with our Pharmacovigilance unit on the reporting requirements regarding Adverse Events. I first questioned, whether it is necessary to perform a Sponsor Causality Assessments (SCA) for all non-serious Adverse Events. The German law "Arzneimittelgesetz" (AMG) requires in § 63b (4):

Der zuständigen Bundesoberbehörde sind alle zur Beurteilung von Verdachtsfällen oder beobachteten Missbrauchs vorliegenden Unterlagen sowie eine wissenschaftliche Bewertung vorzulegen.

The previous sections (§ 63b (1)-(3) talk about Suspected Serious Adverse Reactions, whereas (4) only refers to Suspected Adeverse Reactions. This means that all Adverse Events first have to be assessed with regard to relatedness and consequently all Adverse Events where relatedness is "unknown, not likely, likely, possibly, probably", i.e. all AEs where relatedness is not set to "not related", need to be reported.

After having consulted a considerable amount of secondary material I had to conclude that my argumentation did not have sufficient bearing to go away from the current procedure.

However, since this issue only concerns PSURs (Periodic Safety Update reports) and not Clinical Study Reports and does not require blinded data, we could remove this bottleneck from the Clinical Development Process.

Data exchange standards in the clinical domain

2006-10-26T09:04:00.000+02:00

We are currently undertaking a major program, aiming at an almost complete overhaul of processes and systems in Clinical Development and Drug Safety. I spent yesterday in 2 meetings regarding the information and data flows between the future EDC system (Electronic Data Capture) and the Drug Safety system, and the future CDW (Clinical Data Warehouse).

The meetins clearly indicated that standards are becomingly increasingly important. The current clinical IT landscape is homegrown and all systems are integrated at database level, thus ensuring referential integrity and ease of transfer. However, some of the advantages will be lost due to the strategy of going for COTS (Commercial off the shelf) software. In addition, using an ASP model, or collaborating with external parties, such as CROs (Contract Research Organizations), require that the exchange mechanisms are clearly defined.

In the clinical domain, the set of CDISC standards is becoming more widespread. Consequently, we decided that CDISC SDTM is our choice regarding the internal and external transfer of clinical data. On the other hand, within the Pharmacovigilance domain, E2B is commonly used. Unfortunately, no systems speaks all languages and dialects and we do not have a lingua france for this purpose yet. While waiting for it, we have to teach our systems different languages, i.e. we have to develop interfaces that also allow data mapping and conversion.

BPM Organization in IT or Business

2006-10-24T16:10:00.000+02:00

Yesterday, I was interviewed by a student who is currently writing his MSc-thesis on BPM, more specifically, on the establishment of BPM Centers of Excellence (CoE). He also asked me, where a BPM CoE should be located in the organization.

In many organizations, including ours, the BPM CoE is located within the IT department. Of course, one could argue that this creates a BPM organization that is only remotely connected to the business. On the other hand, there are also good reasons for this set-up:

(1) Being cross-functional IT has a perspective that spans across borders within and across the organization.

(2) The IT unit has no functional stakes to defend.

(3) Since BPM is closely connected to EA (Enterprise Architecture), a close collaboration between these areas is fostered.

(4) BPM also requires a level of IT competence that frequently does not reside within the business organization.

However, this does not mean that BPM can be run as an initiative by IT alone. Close cooperation between business and IT is required and even if the term is somewhat overused, "alignment" seems to be a good expression in this case.

What is BPM?

2006-10-23T19:40:00.000+02:00

I am looking for a good definition of Business Process Management. Any suggestions? Here is my current proposal:

Business Process Management (BPM) is itself a process that ensures continued improvement in an organizations performance. It is thus the meta-process that defines the framework and provides the tools for driving and improving performance in business processes.

There is also a discussion regarding this issue on the BPM Focus discussion board.

Upcoming conference

2006-10-23T18:00:00.001+02:00

On January 30-31, 2007, I will be giving a presentation at a conference on Business Process Management in Berlin. The twist will be on the establishment of a corporate structure and approach to BPM. The slides will be published on my website after the conference.

BTW, the slides from the IIR event on Business Process Management in September are already published there for download, so if you are interested, just go and check them out.

1st entry - Black Forest Group Meeting

2006-10-23T17:05:00.000+02:00

Last week, I participated in a meeting of the Black Forest Group, a relatively unknown, yet rather influential group of representatives of large companies that share a common interest in the use of information technology.

One of the topics under discussion was the influence of blogs and other Web 2.0 (or are we already talking about v 3.0?) phenomena. After having thought for quite some time about becoming a blogger myself, I finally started it today. Let's see what happens ...

The meeting also reminded me of the times when I was working as a researcher. The discussions were really inspiring. I also met Prof. Marceo De Marco and it turned out, that we have a lot of friends and colleagues in common.