Evidence & Performance Blog

In your opinion, and based on your experience, which of the following root causes is curbing good clinical trial performance:

- Lack of methodology to assess metrics of performance, discontinuing the enhancement of informed decision
- Disparate and dispersed critical data, making difficult to have an integrated report “dash board” at a glance
- Isolated teams, creating painful communication loops and useless delays
- Other, please explain..

Leave us a comment with your answer !
We will write an article about the root causes of bad performance very soon, and it would be very useful to have all your thoughts on it !

Thanks

Document management and document control are important parts of clinical quality operations. The Safe association wants to move to a fully electronic business environment by 2012.

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You just joined our LinkedIn group? This message is for you.

First of all, the team behind this blog wants to welcome you to Clinical Trial Performance Spot, the spot where you will be finding all kind of information about Clinical Trial Performance.

In fact we are going beyond just giving information! We want to share our interest about the need of performance in pharmaceutical companies. All our members should be able to advice each other how to reduce delay, time & cost while improving quality and efficiency.

Let me give you a small introduction on the way we thought the blog.
We have several categories on which we are simultaneously working:

• The industry news: here you will be able to find the latest and most interesting news from the global clinical market. Your comments are welcome.
• The technology: here we explain several concepts: what is called clinical trial performance, what is the current status in the market, how will it be measured…
• The methodoloy: here we want to share information about the current needs: what can be done to change the way the pharma companies operate, how can one measure its performance, or its service provider’s performance? The most important is that you share information with us as well.

The spot wants to become a place where we all interact and share information, sometimes agreeing, sometimes not. By pointing fingers on the problems you have to face to daily, we believe and trust in our capacity of resolving them. Someone had to face the same situations, and probably some solutions are on their way.
Tell us your truth – we help finding solutions and won’t forget it…

Stay ahead the curve with the Clinical Trial Performance Spot !

Your highly dedicated team !

And the winner is … PAREXEL !

A couple of weeks ago we learned that Parexel has made an offer of $182 million to acquire ClinPhone, providing software to ease patient recruitment and manage clinical trial data.
Once Parexel made the offer back in June, Quintiles also got interested in the acquisition.

However Quintiles now steps back from the table and they will most likely develop in-house technology to reduce costs of trials.

It looks like Parexel can now complete the acquisition !

As we know there is currently no reliable data on workload measurements nor proven methods which results in unrealistic performance expectations, excessive workload and inefficiency. It is crucial to know the time required to complete a dedicated task, the necessary resources to participate to a clinical trial.

The European Organization for Research and Treatment of Cancer (EORTC) has developed a Workload Measurement Instrument (WMI), used to record the time spent on main activites and the to calculate the cost of recruiting subjects to oncology trials.

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If you want to understand why the pharmaceutical industry is currently undergoing a transition, I am recommending you to read this interesting report from PricewaterhouseCoopers.

PWC clearly “indicates that the current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets. In order to make the most of these future growth opportunities, the industry must fundamentally change the way it operates.”

As I mentioned earlier, it is clear that the Pharma. must quickly find the way to improve its R&D productivity. For us, it is only by measuring the performance that the companies are able to set goals and drive for improvement. This has been demonstrated in others business as finance, and ultimately will prove itself in Drug or Medical Device Development.

Do not hesitate to share your impression with us! 

Pharma 2020 : The vision - which path will you take?
A report from PricewaterhouseCoopers

US-Based eClinical specialist, Datatrak is about to close its doors in Bonn, Germany, first pionner in the industry in Europe in the 90’s.
As Datatrak is now exclusively using their new EDC platform, the support service on their legacy platform has to be reduced – last trial is supposed to last till late 2009.

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YES ! This is just amazing!

Time between last patient’s visit and announcement of the clinical trial results took a bit less than seven weeks! Yes seven weeks, where it usually takes months, to get the final results out!
This happened to a sponsor with the help of Nextrials support and its EDC Software Prism!

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ClinPhone, the world’s leading Clinical Technology Organization, will be acquired within the next couple of months.

CRO Parexel already made a $182 million bid, however Quintiles is discussing the acquisition azs well, and if they agree it will most likely be more than what Parexel offers.

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