Contract Research Organization Getting You Down? 9 Tips for a Smooth Transition
June 28, 2012
If you’ve been disappointed by your current contract research organization (CRO) you may want to transition your clinical trial or development program to another CRO. These tips can help make the transition as smooth as possible.
Creating a transition plan that accounts for the objectives and concerns of all stakeholders—you (the Sponsor), the existing CRO, the new CRO, study sites, and other providers (e.g. drug supply vendor, central labs, central IRBs) can make this difficult task easier.
In our experience, the following areas are of primary concern when transitioning projects:
1. Established, clear and realistic goals for the transition process.
2. The existing CRO’s cooperation in transition process.
3. Ensuring data and information transfers are accurate and complete.
4. Assessing potential roadblocks and implementing preventive processes and solutions.
Work with the new CRO to accomplish the following early in the process:
5. Conduct a comprehensive analysis of existing issues and challenges.
6. Establish a communication plan for the initial transition.
7. Establish a transition leader committed to a seamless transfer to act as a central point of contact.
8. Assess the transitioning CRO’s systems, processes, and quality.
9. Create a transition plan to be approved by all key stakeholders.