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.
Approach
We created a data pipeline that met CDISC SDTM and ADaM standards, pulling data from six CROs and three internal sources. We applied consistent transformations and checked the results against CDISC rules. We also set up data governance to enforce standards on all future CRO contracts, stopping similar data issues before they start.
Outcome
We cut FDA submission prep time from 14 weeks to 3 by streamlining data workflows. Biostatisticians spent about 11 fewer weeks per submission on data transformation thanks to automated processes. CDISC compliance on first submission jumped from 84 to more than 99 of every 100 after tightening data standards. The governance framework we built is now the default for all new CRO contracts.
How We Got Our CRO Data Speaking CDISC for Cleaner, Smoother Reports
Alright, here’s the scoop. Every CRO we worked with had their own way of collecting and labeling data. And to make things trickier, they all used different file formats. Total chaos. So, we built this transformation layer that cleaned everything up and got it all into the CDISC SDTM format. Since their processes kept changing, we kept things flexible by maintaining CRO-specific mapping tables and updating them as needed. Plus, we set up automated checks to catch any data that didn’t meet the standards before it could cause problems down the line.
How We Tackled Managing Those New CRO Contracts
CROs were all over the map with their data submissions because there wasn’t a clear standard. So, we got together with regulatory affairs and clinical ops and hammered out a data standards appendix for every new CRO contract. This appendix laid out exactly which variable names to use, the formats, and how the data should be delivered. Problem solved, no more weird or off-the-wall data slipping through.
Results
- 14 to 3 weeks FDA submission preparation time
- 11 weeks Biostatistician time saved per submission
- 84 to 99 of 100 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.