Pharma & biotech · 2024 · anonymized
Phase III oncology TLF package
ADaM conversion and a full TLF package for a Phase III oncology CSR, delivered to medical writing with zero critical findings at sponsor QC.
Challenge
The sponsor’s programming bench was committed to two other studies. Database lock was fixed. The TLF list ran past four hundred displays, including nested safety and a complex PFS analysis.
Approach
We named a lead and a QC programmer in the first week, rebuilt ADaM against the SAP, and split production into primary-endpoint, safety, and appendix waves so medical writing could start before the last listing landed.
Result
Package accepted at sponsor QC with no critical findings. CSR appendix handed over in eight weeks from kickoff. The same pair stayed for agency questions.
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.