Functional Service Provider (FSP)

The proficiencies you need. Without the capital investment.

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Flexible options for a fast-changing industry

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. Our global presence means we can swiftly scale to meet your growing needs — without the constraints and capital investment of hiring full-time staff.

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

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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
Pre-clinical through post-marketing: global FSP models to meet a range of needs

In a dynamic, demanding clinical research environment where regulations continue to evolve, our flexible sourcing approach gives you access to deep clinical development expertise and extensive resources where you need it.

Premier Research’s FSP models provide you with the functional resources to support your product development program anywhere and at every stage. You fine-tune your level of involvement, deciding how hands-on (or off) you want to be.

 

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Roles may include:

  • Data managers
  • Site monitors
  • Biostatisticians
  • Pharmacovigilance professionals
  • Regulatory affairs professionals
  • Medical writers
  • Study management experts
  • TMF experts

One size doesn’t always fit all. As a full-service global CRO, Premier offers agile solutions to meet your unique needs. Our traditional FSP model fits seamlessly with our full-service model to allow you to customize the partnership:

  • Traditional model: We can provide teams of dedicated, centralized functional experts who can move from study to study supporting key areas — or a strategic few to support a very specialized area of your trial.
  • Hybrid model: Take advantage of Premier SOPs and systems for some study components under our full-service model, while centralizing and maintaining control of key functions through our traditional FSP model.

To succeed, today’s trials require new skills, understanding of changing clinical trial requirements and processes, and technology and data savvy — sometimes you need an entire department. We can deliver a complete package of support, such as supplying traveling CRAs, data managers, and central monitors to conduct study work while navigating the latest mHealth systems. To augment our FSP experts, Premier offers access to our unique Premier One Ecosystem, integrating all study data into one platform and then applying powerful analytics and skilled analysts to deliver crucial insights.

Study Monitors
  • Central monitors and clinical research associates
  • Medical expertise
  • Statistical expertise
  • Clinical data analysts
  • Site management tools*
  • Dashboards: Real-time data visualizations at the patient, site, or study level*
Safety and Risk Management
  • Risk-based quality managers
  • Key risk indicators, quality tolerance limits, workflows & standard operating procedures (SOPs)
  • Medical & regulatory affairs
  • Dashboards & reporting tools*
Biometrics Support
  • Biostatistics & programmers
  • Medical writers
  • SOP development
  • Interactive Response Technology system*
Study Intelligence
  • Clinical data scientists
  • Dashboards and reporting tools*
Service Provider Monitor
  • Clinical operations
  • Data analytics
  • Vendor data aggregation
  • Dashboards & reporting tools*
Consulting Resources
  • Study designers
  • Product development experts
  • Regulatory strategists
  • Legal professionals

* Part of the Premier One Ecosystem

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 from operations to regulatory, strategy to product development. Rapid scale-up can pose a challenge — and Premier solves it. We supply localized or expanded functional leadership, services, and technologies related to key roles, helping advance your science without taxing your bottom line.

People meeting to discuss avoiding an IND clinical hold.

HOW WE HELP

Getting started with Premier FSP

We have created a flexible sourcing approach that gives operational teams the benefit of our clinical research expertise and access to our extensive resources. Not ready to move to an FSP model? We can help you build out a framework for success.

PREMIER INSIGHT 246

Flexibility and cost savings ahead

Functional outsourcing can produce significant savings and greatly increase flexibility in assigning resources. But any big change in staffing requires care to avoid personnel disruptions, keep projects on track, and comply with laws governing use of contract employees.

Looking for something else?

For information about Premier Research’s in-house clinical development and consulting expertise or general requests, get in touch with us here.