Evidence & Performance Blog

I’m coming back on initiatives around Performance Metrics in the Clinical research area. Someone forwarded me this interesting link: http://www.eclinicalforum.com/

You can find a very good and complete survey of companies involved in conducting EDC trials to assess the feasibility of establishing standard metrics for the assessment of EDC performance. It is not a new document (June 2004) but it gives very useful and focused approach to benchmarking EDC performance.

Lorena Levi, Trainer at Fundacion Cecilia Grierson in Argentina, is sharing with us her experience in operational and performance management in South / Latin America.

Lorena and myself talked about this in the past week, and I am now sharing her thoughts with you. Read more

Christophe De Vleeschouwer, Manager Medical Operations for Cordis Medical (a Johnson & Johnson company) in Belgium, is exposing his thoughts and needs about measuring performance for large cohort clinical registry. Christophe has met us last week, and Alex took his confessions. Read more

We recently covered the topic about dispersed and disparate data.
Within one company, if you have a horizontal view across all trials, you will notice that data is stored in various formats, including diverse relational databases, text files, XML files, spreadsheets and certainly proprietary storage formats. There is no unique way of collecting, organizing and analyzing data.
The problem is to utilize of this critical data to assess the trial’s or program’s performance. Read more

Does the clinical trial area need performance tools? YES!
More and more companies start to think of a more efficient way to run clinical trials. What they want is easy: reduce the costs, reduce the time, and enhance the productivity.
How can they achieve this goal? By measuring the performance of the clinical trials and the service providers (Lab, EDC and other vendors, R&D …). Read more

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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