Functional Service Provider (FSP)

Flexible sourcing options for a fast-changing world

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Processes, technologies, and training to move your study forward

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. You fine-tune your level of involvement, deciding how hands-on (or off) you want to be.

Premier Research’s FSP model provides you with the functional resources to support your product development program at every stage, including these key areas:

Medical Writing

Access to credentialed writers in the U.S. and Europe across multiple therapeutic areas.

Regulatory Consulting

Full-service strategic and tactical product development strategy at all stages of development.

Electronic Publishing

Publishing and document management services, including electronic Common Technical Document (eCTD) submission and electronic Trial Master Files (eTMFs).

Data Operations

Cost-effective data management solutions, from server hosting to siting data operations in cost-friendly markets.

Service Offerings

Biostatistics

Biostatistics

Data Management

Data Management

Development Consulting

Development Consulting

Electronic Publishing | eCTD

Electronic Publishing | eCTD

Electronic Trial Master File | eTMF

Electronic Trial Master File | eTMF

Global Compliance

Global Compliance

Medical Affairs

Medical Affairs

Medical Writing

Medical Writing

Project Management

Project Management

Quality Management & QA

Quality Management & QA

Regulatory Consulting

Regulatory Consulting

Safety & Pharmacovigilance

Safety & Pharmacovigilance

Study Design

Study Design

Study Start-Up

Study Start-Up

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.

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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.