CASE STUDY

Background This case study applies the estimand framework from ICH E9(R1) to a clinical trial comparing the efficacy and safety of a fixed combination of two components with each component used in monotherapy for patients with bilateral ocular hypertension or open-angle glaucoma. The randomized, double-masked, multicenter trial enrolled 335 patients and assessed intraocular pressure (IOP) …

Estimand Framework : Ophthalmology Trial Evaluating a Combination Therapy >

Case Study: Streamlining Data Management for a Gene Therapy Trial Integrating EDC and EHR 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 images from the EHR (Electronic Health Record) with their clinical database …

Integrating EDC & EHR 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 >