DSG - The case for FSP

DSG has experienced large amounts of success by working as a Functional Service Provider (FSP) to sponsors and CROs in need of eClinical software (EDC, IRT, CTMS and more) and clinical data management. If you have not considered the benefits of utilizing an FSP there is no better time than today to consider the advantages over traditional full-service Clinical Research Organization (CRO) models.

FSPs are essential partnerships to the overall success of modern day clinical trials. They provide multiple facets of the clinical trial tasks such as design, medical writing, statistical services, trial recruiting and electronic submission to agencies. In the past, clinical studies were entirely managed by large full-service CROs, which provided a disadvantage to clinical project managers because they could only choose from one or three large full service CROs. As times have changed, so has the model. Many biotech, medical device and pharmaceutical organization are employing the FSP model to separate core and non-core capabilities within the organization, allowing flexibility to bring in providers specializing in particular areas and capabilities while focusing on essential services to the study.

The CROs’ site monitors may have worked on similar studies or claiming to have experience in a particular therapeutic area. However their team can lack the experience around biostatistics and data management and building an end-to-end electronic data capture system and workflow for specific trials. Full-service CROs are for-profit business that will sometime lead with and push certain FSP partners and eClinical systems best serving their own purposes versus partnering with an aligned FSP that offers specific capabilities to the clinical trial and focus area.

FSP models have several key advantages than CROs in addition to cost efficiency. An FSP can reduce the burden of hiring and retaining non-core competencies and significantly reduce the time to bring new drugs and therapies to market and create efficiencies that impact the bottom line of organizations. FSP have been increasing in popularity because of their ability to bring drugs to the market quickly and the reduced cost implications.