Functional Service Provider (FSP)

Flexible options for a fast-changing industry.

Access to deep clinical development expertise & extensive resources where you need it

Overview

For rapidly scaling global companies — whether focused on medical devices, cell and gene therapies, rare diseases, or other life-changing medicines — the path from concept to commercialization is multifaceted. You need expertise in a vast array of areas, but rapid scale-up can pose a challenge. Premier can solve this problem. We supply localized or expanded functional leadership and service teams—large or small—of dedicated experts that will help advance your science without taxing your bottom line.

Since 1998, Premier Research has partnered with leading pharmaceutical, biotech, and medical device sponsors worldwide to deliver long-term support for key functions as well as meet project-specific needs. We provide access to a dedicated corps of experts around the world, including key life sciences hubs in emerging markets such as India, China, and South Korea, who work alongside your study teams.

We can source for roles including CRAs, biostatisticians, data managers, medical writers, pharmacovigilance professionals, regulatory affairs professionals, site monitors, study management experts, TMF experts.

Why choose Premier?

With pre-clinical, clinical, and post-marketing models, we have the expertise and flexibility to meet a broad range of needs and shift focus based on study demands.

  • Complete customization: Define the role, determine the reporting structure, choose embedded vs. remote — each engagement is structured to meet your precise needs
  • Ongoing adaptability: Adjust roles and responsibilities as study, regulatory, and industry requirements evolve
  • Optimal savings: Free your budget and eliminate searching, hiring, training, and management headaches
  • Trusted support: Leverage Premier’s clinical trial expertise and technical savvy, pairing people and systems to extend your core team
  • Demonstrated longevity: Benefit from proven, long-standing partnerships that make us an extension of your team in ways that can span a decade or more
  • Our Global Presence: We can swiftly scale to meet your growing needs — without the constraints and capital investment of hiring full-time staff.
  • Access our proven processes: We can provide traditional teams—large or small—who adapt to your SOPs and systems or leverage Premier SOPs and systems to minimize your SOP oversight

Service Offerings

  • Biostatistics
  • Data management
  • Development consulting
  • Electronic publishing | eCTD
  • Electronic trial master file | eTMF
  • Global compliance
  • Medical affairs
  • Medical writing
  • Project management
  • Quality management & QA
  • Regulatory consulting
  • Safety & pharmacovigilance
  • Study design
  • Study start-up

resources

Stay ahead of the curve by browsing our extensive library of white papers, case studies, blog posts, and more.

Ready to get started? So are we.

Drop us a line to learn more about how we can help.