Situation

A small US-based biotech client needed Clinical Monitoring Oversight on a Global CNS Program. A large CRO was responsible for the clinical management on the Program. Client felt that additional support of the monitoring team via Clinical Oversight would benefit this program. This Program included 4 separate projects that were conducted in 18 countries.

Solution

• Catalyst put together a Global Team. Client systems and processes were utilized.
• Catalyst team consisted of 5 Clinical Trial Managers, 18 Oversight Clinical Monitors, and a dedicated Clinical Resourcing Manager (CRM).
• Site assignments for the Clinical Oversight Monitors were maximized to cover multiple projects in the portfolio as well as multiple countries, where language permitted.

Catalyst Difference

The Catalyst CRMs are dedicated industry professionals, not just recruiters. The CRMs are pivotal in facilitating selection of the team members and monitoring team oversight. They make sure that everything fits together and runs smoothly. Oversight Managers deployed on this program have an average of 15 years of Clinical experience.

As a result of our successful collaboration, Catalyst has been awarded the Oversight Monitoring work for the client’s next Phase III pivotal study that is due to start in September of 2023. Catalyst team is looking forward to supporting this large global program with our expert Clinical Monitoring team members. Catalyst will be working with our Sponsor on a resourcing strategy that is the most efficient and effective for this Study.