Power Past the Plateau to FSP Success - Applied Clinical Trials


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Power Past the Plateau to FSP Success

Source: Applied Clinical Trials

Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.

Functional service provider arrangements, or FSPs, are evolving beyond the clinical data management tasks they were designed to streamline. FSP models can offer trial sponsors cost savings of 30 to 50 percent by reducing infrastructure and overhead expenditures. These outsourcing arrangements can also bring strategic and operational benefits.

As attractive as FSPs can be, outsourcing is not a panacea. Most FSPs hit a performance plateau about 18 months after implementation. Challenges in scaling up operations, inadequate resourcing, suboptimal resource utilization, quality control and general operational fatigue can jeopardize performance, delivery, and quality as mistrust and doubts grow.

“If the FSP is to be successfully navigated across the plateau, the point at which significant operational issues begin to surface, the partners must press forward in good faith, relying on each other’s experience and expertise toward effective operationalization of services” said Theo Erasmus, MS, Chief Executive Officer of South Africa-based CROs ClinData International and ClinVet International.

The former Vice President, Global Functional Resourcing (Biometrics) for Quintiles was lead author on a paper outlining strategies to conquer the FSP plateau. The authors outlined specific interventions to power the FSP partnership into long-term success:

  • Strong and experienced FSP leadership that is designed to be scalable with growth.
  • Alignment of sponsor and FSP goals and expectations early in the partnership.
  • Sponsor buy-in and support at all levels from the C-suite down.
  • A clear governance and communications plan that specifies how and when issues will be escalated.
  • A strong focus on projects and project management.
  • The use of both retrospective and prospective metrics to track progress.

“The benefits of FSP arrangements ensure they will continue in popularity as long as the FSP can break through the 18-month plateau,” he said. “CROs need to take a proactive role to optimize productivity and quality while continuing to keep costs under control.”


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As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
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