Catalyst Flex Delivers Clinical Monitoring Oversight Experts on Phase III Global Study
Situation
A small US-based biotech client needed clinical monitoring oversight on a global central nervous system (CNS) program. The client felt that additional support of the monitoring team via clinical oversight would benefit this program. This program included four separate projects conducted in 18 countries.
Solutons
Catalyst put together a global team that used the client’s systems and processes. The Catalyst team consisted of five 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.
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.
Outcome
As a result of our successful collaboration, Catalyst was awarded the oversight monitoring work for the client’s next Phase III pivotal study due to start in September of 2023.
The 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.