Case study
Overview
TFS was selected by a small biotech company to provide full CRO service to conduct a global, exploratory immune oncology phase II study in Metastatic Renal Cell Carcinoma. Service included: Project Management, Site Management, Regulatory Management, Data Management, Safety, Medical Writing and Biostatistics. Study was started in April 2015, recruitment was ended December 2017, last patient last visit was conducted 17th June 2019 and DBL and Top Line Result was delivered in August 2019.
- 117 patients screened to obtain 88 randomized patients
- 24 sites across Europe were selected by TFS
- 5 sites in US were selected and managed by US CRO
- 8 Amendments were executed
- Study Phase: II
- Indication: Metastatic Renal Cell Carcinoma
- Sites: 29
- Services: Full Service
Challenges
- Complex study with many changes including changes to study design and primary objective
- Vendor Management (including many small unexperienced companies)
- Late changes to exploratory objectives, requiring retrospective data collection close to DBL
- Complete Survival Collection (primary endpoint) close to DBL
- Crucial for client to deliver Top Line Results according to agreed and communicated timelines
