CRO TRANSITIONING - PLANNING AND EXECUTING

WIN Outsourcing Consult offers support in going through the entire decision-making process of transitioning from one CRO to another.

Failing clinical studies can result in delays in project’s milestones and decision points, delays in submissions, increases in costs for the Sponsor and, ultimately, lack of treatment options for patients awaiting treatment.

Reasons for failing studies are plentiful – some reasons involve issues around the site start-up process, patient enrolment/retention barriers, protocol compliance and complexity, data quality and integrity, resourcing issues, and overall CRO personnel’s qualifications and expertise.

Making the decision to transition a study to another CRO must be well founded because the transition itself may be lengthy, costly and/or difficult to execute.

Many companies have failed (and paid the price) by not having performed appropriate pre-planning, risk-assessments and analysed possible strategy scenarios – exercises most likely not performed due to either lack of resources, time and/or the appropriate expertise. 

Those who have been successful in CRO transitions have realized that the resources and time spent are far more awarding for the study outcome than continued struggles in managing a non-performing CRO.

WIN Outsourcing Consult's offerings includes both planning and executing CRO transitioning

• Facilitation of the decision making proces
  • Risk Assessments, Root cause analysis, Transition Plan, Communication Strategy, Recommendations and Decision Strategy
• Execution of the Transition plan to best secure the study’s momentum, communication lines, cooperation with CROs, oversight, budget and implementation - this includes
  • Identification of potential rescue CROs, RFP, CRO meetings, CRO selection etc.
  • Communication strategy (internal and towards both CROs)
• Negotiating terms with both incubent and incoming CRO in collaboration with a legal advisor of Client’s choice or with one of WIN Outsourcing Consult's legal collaborations partners
• Ensuring most optimal governance and oversight in the transition period