Archive for October, 2008
Pharma. Challenges: Executive Interview with Dr. Pierre Le Sourd
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.
4 commentsCDISC and HL7 “BRIDG”ed together
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
No commentsClinical Trial Performance Metrics Event !
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 !
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