CASE STUDY

Case Study: Streamlining Data Management for a Gene Therapy Trial Integrating EDC and EMR Platforms in a Phase 2 Diabetic Ulcer Study Background A biotech sponsor developing a gene therapy for wound healing in ulcerative patients needed a robust data management strategy to reconcile EHR images with their clinical database (EDC). The Inference DM team …

Integrating EDC & EMR for Gene Therapy in Phase 2 Diabetic Ulcer Trial >

Objective A small oncology biotech company with an expanding pipeline required a flexible resourcing model of statistical programmers to address their immediate priorities. One crucial need was supporting database lock (DBL) and Clinical Study Report (CSR) activities for a Phase 2 solid tumor study while developing project timelines for key objectives. The Inference team prepared …

Enhancing Clinical Data Quality: A Programmatic Approach for RECIST Data Checks in Oncology Studies >