Evidence & Performance Blog

Open Source: new model for the EDC systems?

An Interview of Ben Baumann from Akaza Research who gives his point of view about the benefits of the open source model comparing to the ‘old-fashioned’ EDC Solutions.

Thank you very much Ben for sharing your thought about this topic ! Read more

An interview with John Di Matteo, Performance Measurement Consultant

John Di Matteo is currently an Independent Contractor for Thomson Reuters. He is currently working with the CMR Group on the Clinical Metrics Programme Survey. He has twenty years of clinical development experience across the key functions of clinical research in large Pharma company environments, including Johnson and Johnson, Schering Plough and Bristol-Myers Squibb. As divisional Performance Measurement Lead for BMS, he directed the development and implementation of operational performance measurement that supported improvement of late-stage clinical research processes, as well as incorporation of industry benchmarking information to support leadership’s assessment of their relative operational performance. Read more

Assessing the performance of CROs

Pharmaceutical and biotech companies want to speed up the research and development process whilst adhering to stricter guidelines. That’s why CRO’s are primarily selected on their scientific expertise and the cost/value ratio.

If R&D companies have always had a ‘feeling’ about their CRO, they are now more and more looking for facts in assessing their performance. This can only be done by “Choosing the right metrics” and “Deploying the right tools to evaluate these metrics”. Read more

Dear Readers and Contributors

As the end of the year is coming closer, we would like to write a few personal words.
Thanks to all of you, we were able to set up a great group, and we were able to launch our blog in June 08!
Your experience and advices helped us to grow and to continuously provide top notch information and feedback from the field.
We want to sincerely thank you - your contribution is essential to us!

We are already working on some innovation for our group so that the good communication keeps ongoing, and the group becomes even more interactive !
Any ideas and request for participation are welcome, don’t hesitate to contact us !

We wish you all the best for a prosperous, heathly and successful 2009 !
Happy New Year !

Your dedicated team

In September’s edition, Applied Clinical Trials has published an thorough article on computer simulation models that would have a direct benefit on patient recruitment and site selection.

You can read the article online, by clicking on this link.

This article demonstrates, once again, the specific need of pharmaceutical companies to manage their clinical trial in a cost effective and time saving way. By knowing on a daily basis what the status of the trial is, clinical trial lead and project managers will be able to take informed decision on their trial to meet the target: getting the drug to market, sooner - cheaper - but with higher quality !
This will also help upper management to have a correct big picture of all trials, compounds current running in their company, and makes them take informed decision as well !

We had the pleasure to meet Doctor Pierre Le Sourd, former President of Bristol Myers Squibb France and most recently President of the Leem (The French Pharmaceutical Companies Association).

Mr Le Sourd brings us 30 years of pharmaceutical experience to help us understand current challenges and perspectives in this industry.

Read more

We almost all know what CDISC is. It is a consortium that develops and maintains clinical data standards, like SDTM (Study Data Tabulation Model) and ODM (Operational Data Modeling).

The purpose of SDTM is to store clinical trial data, in XPT format together with standardized and organized metadata.

The purpose of ODM is to store not only clinical data, but also all data belonging to clinical trials (protocol, queries, DCF, data, metadata, audit-trail …) in XML format.

On the other hand we have the HL7 standard. Standardized messages related to the electronic patient file used to exchange patient data across the hospital structure. Typically a record could contain patient’s information, their consultations, their prescriptions etc…

Those two different worlds try to get closer to each other; in fact they deal with the same information, because some of the clinical data is already captured in the patient’s record. It would be a high benefit if some data coming from the hospital could already be integrated in the clinical trial.

The BRIDG Model has been designed to link both clinical research data and patients file data.

Of course, both standards are quite different, so the challenge lies in the integration of one standard with the other.

Initiated a couple of years ago, the BRIDG project demonstrates that data integration is not easy, and cannot be done over a night.

But what will be done in a long term period? Keep both entities and bridge them together? Wouldn’t it be more profitable to have a unique standard for both? But is it feasible?

More information can be found here: HL7, CDISC, BRIDG.

Additional information can also be found here: http://www.clinpage.com/article/the_future_of_odm_sdtm_and_cdisc/C12

The 6th annual conference will take place in London from January 27th to 29th, 2009!
We are of course looking forward for this unique event in Europe, as its focus is Performance, and Metrics used to accelerate development, improve quality and streamline decision making.

By joining the performance metrics event, you will:
- benefit from the experience of top pharmaceutical companies like JnJ, AstraZeneca, Eli Lilly, Astellas Europe, Baxter, Bayer, CMR (Center for Medicine Research) !
- understand how the implementation and application of performance metrics can improve your clinical trials
- benchmark your performance metrics procedures: gain vital advice from leading pharmaceutical companies from across Europe and globally
- keep up-to-date with the latest performance metrics issues including using metrics to predict risk

We are very pleased to announce that we will be joining the event, not only listening to the conference but also actively participating!

Alex. Durand-Salmon, Co-author of the blog will share his experience regarding Performance dedicated to Service Providers in the conference “Case study: A real life example of using metrics to  assess the performance of a service provider”.

Also Christophe De Vleeshouwer, Manager Medical Operations at CORDIS (Belgium) who already shared with us his experience regarding clinical trial performance (will held the conference “Critical guidance on the choice of metrics: how to best use them in the frame of pre- and post-market studies and registries”.
If you are interested in listening to the 2-day conference, feel free to visit www.informa-ls.com/metrics and get registered.

Should you not be able to go this event, please let us know your particular points of interest, and feedback you would like to have from this conference !
Shortly after the event we will give you an update !

Thanks for your participation !

Datatrak is highlighting ease of access to site performance metrics as a key differentiator as it launches the latest version of its platform eClinical product suite.

The latest version of eClinical suite is tracking metrics on investigative site performance in clinical trials. Read more