In March 2024, the US FDA issued its guidance, “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” outlining the agency’s objectives for protecting public health as artificial intelligence (AI) and other technologies become more prevalent in healthcare.
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.