We used three proprietary databases on clinical trial costs, which are offered by Medidata Solutions, a global provider of cloud-based solutions for clinical research in life sciences, as part of the broad set of solutions available through the Medidata Clinical Cloud™:
- Medidata Grants Manager® (PICAS® database) – PICAS provides industry-wide negotiated site cost information. It is a database of negotiated investigator grants—it includes more than 250,000 grants and contracts and 27,000 protocols in over 1,400 indications—that provides benchmarked costs typically used for clinical trial budget planning.
- Medidata CRO Contractor® (CROCAS® database) – The CROCAS database contains thousands of negotiated outsourcing contracts. It includes comprehensive data from CRO contracts—detailed across such dimensions as therapeutic area, phase, and geography.
- Medidata Insights™ – Medidata Insights is the turnkey clinical analytics solution that provides advanced visualization of clinical operational performance metrics alongside company and industry benchmarks. The Insights metrics warehouse is comprised of data from more than 7,000 studies gathered seamlessly from over 120 clinical trial sponsors.
We obtained custom aggregate tabulations from Medidata by therapeutic area, phase, and geography (domestic versus international) for the full range of cost elements associated clinical trials (averages as well as variances). Cost components included cost of IRB approvals, cost of protocols, patient recruitment costs, and administrative staff costs among others. Appendix B provides the Medidata data elements and their descriptions.