Pharma & biotech · 2023 · anonymized
CDISC conversion, rescued mid-study
A study inherited with incomplete specs and a coding backlog. We took data management and programming through freeze, lock, and SDTM/ADaM.
Challenge
The previous vendor left incomplete edit checks, an uncoded AE stack, and SDTM that would not survive Pinnacle 21. Lock was already late.
Approach
Two workstreams: data management closed queries and coding in the first fortnight; programming rebuilt SDTM and ADaM against a freshly agreed spec, with weekly Pinnacle 21 scores visible to the sponsor.
Result
Database locked in eleven weeks. SDTM/ADaM package used for the CSR without a further conversion round.
Tell us what is on the clock.
A scoping call is thirty minutes. Bring a protocol, a TLF list, or a model that needs hands.