Clinical Trials vary a lot depending on investigated drug , Indication and patient population, so it is easy to understand why most clinical teams consider their trial to be special and find it difficult to be treated with a "standard approach" . However, in today's corporate and regulatory environment it has become a critical requirement to "pool" safety and efficacy data so valuable information can be retrieved from meta analysis of BIG DATA warehouses.
The Clinical Data Interchange Consortium (CDISC) was founded "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare".
The FDA has embraced and supported the vision of CDISC by making SDTM and ADaM a required format for electronic submissions following the eCTD standards.
We have been involved in implementing data standards (SDTM, ADaM, CDASH, ODM, Study Trial Design) for multiple customers. There are numerous published case studies demonstrating the tremendous efficiency gains these global standards have provided.
If you are interested in learning more about CDISC standards and how they can help you to improve your Clinical Program, please give us a call.