Mid-Size Pharmaceutical Company · Life Sciences · Boston, MA · 16 weeks
Clinical trial data governance framework deployed
A mid-size pharmaceutical company struggled with a 14-week FDA submission process due to clinical trial data scattered across six CROs and three internal systems in inconsistent formats. We created a data governance framework and built a CDISC-compliant data pipeline that cut the preparation time to three weeks.
Challenge
The company managed clinical trials through six contract research organizations, each using unique data formats and variable names. Preparing a CDISC-compliant submission meant manually converting data from all nine sources. This process took 14 weeks of biostatistician effort and created the main delay in meeting regulatory deadlines.
Outcome
We cut FDA submission prep time from 14 weeks to 3 by streamlining data workflows. Biostatisticians spent 78% less time on data transformation thanks to automated processes. CDISC compliance on first submission jumped from 84% to 99.2% after tightening data standards. The governance framework we built is now the default for all new CRO contracts.
Results
- 14 to 3 weeks FDA submission preparation time
- 78% Biostatistician transformation labor reduction
- 84% to 99.2% CDISC conformance rate on first submission
- 6 CROs Standardized under unified data governance framework
We used to spend 14 weeks assembling FDA submission packages because our CRO data was scattered. Thinklytics built a pipeline that cuts that down to 3 weeks and catches conformance errors early before they become bigger problems. It made our regulatory process a lot faster.