Case Study 2

Metastatic Renal Cell Carcinoma Case Study

SITUATION

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

TFS SOLUTION

  • An incentive payment scenario with bonus or penalty linked to milestones important for the project success was agreed in the contract.
  • TFS managed to deliver Top Line Results according to agreed timeline to receive a bonus. To meet this TFS delivered DBL 1 week ahead of the original agreed timeline from LPLV.
  • An extremely experienced and dedicated team was accountable for the close out deliverables. The strength of the project team allowed us to efficiently solve the unexpected issues and challenges that occurred during the close out phase.
  • TFS put in place a detailed cross-functional time and resource plan with day-by-day activity from LPLV to DBL. Time plan was shared, discussed and agreed with the core team members and management team, and the importance of meeting the agreed timeline was highlighted early. Project Manager did close follow up to make sure activities were delivered as planned and if not immediate remediate action were put in place to get back to original time plan as well as oversight form the leadership from the Oncology & Hematology Center of Excellence.
  • TFS worked with proactive planning for the data cleaning. TFS identified all activities that could be finished before LPLV to ensure a smooth and efficient transition from LPLV to DBL. This included allocation of patients into batches in the EDC system to facilitate tracking, cleaning and medical review work.
  • TFS established a close relationship and collaboration with client with a transparent reporting of identified study challenges and mitigations.
  • TFS established close collaboration with vendors to help them meet their deliverables and keep timelines.
  • TFS established close relationship with sites to ensure continued dedication and timely response until the study closure.

CLIENT ADVANTAGE

  • Cost and timesaving for the client: Delivered DBL 1 week ahead of the original agreed timeline from LPLV.
  • Outstanding issue resolution and risk mitigation due to accessible local project team, local support by upper management and transparent communication.
  • Easy access to upper management via continuous governance meetings, which resulted in fast issue escalation.
  • Efficient cross-study safety handling and post study survival follow up due to sole responsibility from one safety department including one safety database.