DSG - Practical implications of an FSP

The clinical input needed in the eClinical data systems design-build process and subsequent data management is very limited. This means that splitting a traditional all-in-one CRO contract among two specialized FSPs – one for clinical, and one for eClinical data management (EDC, IRT, eCOA/ePRO, CTMS, and more) does not require sponsors to build a team of FTEs (full-time employees) to manage two versus one contract.

Input from the “owner” of the protocol is useful during start-up. Training monitors on effective use of eClinical systems to make them more efficient in their site visits. That is it. Interaction between the biostatistician ultimately responsible for defending endpoints before an Agency committee, giving direction from the beginning, harmonized with data managers and system builders. The result is ALWAYS drastically more efficient trials.

This development flow brings delays down to the barest minimum and escalates accountability to the maximum. It reduces “scope creep” nearly to zero, unless the “owner” of the protocol makes changes or amendments. Absorbing and executing systems changes is far faster and more efficient with FSP due to contract labor and unit rates pinpointing all costs. With full-service CROs, changes absorbed by various “departments” often total to astronomical sums making it difficult for the sponsor to force an accurate, coherent defense of scope changes.

Sponsors who have mastered the FSP model stick with it. Industry migration is not in the other direction, from FSP to full-service CRO model – the aforementioned is why.

Want to learn more? Download our free White Paper “eClinical Data Management: The New Industry Framework for FSP” to find out more about the steps involved in choosing a FSP model.

Or contact Kelly Morrione by email to learn more: Kelly.morrione@signanthealth.com.