Drug development has dramatically changed over the past ten years. Specifically, when it comes to GxP compliance and validation. Many biopharma companies struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. In this white paper, we will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
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.