OCT Case on FDA-Compliance for an Immuno-Oncology Biotech: Data Management for a Long-Term Melanoma Trial

A First-in-Human cancer immunotherapy study for advanced melanoma comes with high complexity and constant protocol evolution. For our European biotech client, this meant 14 protocol versions, 9 major CRF amendments, over 26,000 completed e-forms, and more than 10,000 coded medical terms — all across a 9-year timeline. OCT designed a robust database architecture that absorbed frequent updates without disruption, implemented multilevel verification involving the Sponsor, and ultimately delivered 51 SDTM / FDA-compliant datasets. Discover how we maintained quality and consistency despite the sheer volume and duration of the project.

Download the full case study to explore our data management expertise in immuno‑oncology.