Data exchange standards in the clinical domain

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.