A biopharmaceutical company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. Only later did they discover that the Trial Master File documents were scattered across hundreds of boxes of paper and several hard drives. The company was facing critical submission deadlines and the risk of losing financial incentives related to the product acquisition – with zero insight into potential TMF quality and completeness issues that could lead to a failed inspection and delayed submission. Read the case study, “From Liability to Asset: A TMF Rescue” to discover how Phlexglobal’s unique blend of TMF expertise and services turned a “black box” into an inspection-ready TMF – ahead of schedule.
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.