While the FDA has issued guidance to help sponsors, investigators and IRBs decide on the best ways to protect patients while keeping their trial moving, the decision is ultimately up to each individual research team. IMARC has assisted research teams with remote monitoring, auditing and other activities for years. More recently, our team helped one company transition to an entirely remote clinical trial. We wanted to share this example to show it can be done, under certain circumstances and with careful consideration.
Enhancing Clinical Trial Flexibility
July 22nd 2024As drug development costs continue to escalate, sponsors are incentivized to find less expensive approaches to develop their assets. FSP models provide increased operational and resourcing flexibility and different pricing plans in comparison to traditional full-service CRO offerings.
Comprehensive and flexible partnership with functional services for rescue study
July 22nd 2024Large CROs operate with a one-size fits all approach, when this no longer worked for a late-stage clinical biopharmaceutical company, they turned to Catalyst Flex to design a tailored solution to meet the safety needs of this rescue study.
The Expanding Role of Functional Service Providers in Clinical Research
July 22nd 2024This article explores the strategic importance of FSPs in clinical research, emphasizing their contribution to cost-efficiency, the acceleration of drug development, and technological innovation in trial management.