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CLNICAL STUDIES
CLINICAL STUDIES

Provision provides world-class clinical studies services to our most valued clients that need to meet FDA compliance requirements.

The clinical development process isn’t easy. It’s riddled with complexity and risk, which can cost your organization significant time and money.

We offer a variety of clinical studies services that bring together our global clinical and regulatory expertise with proprietary technologies to simplify your journey to market.​

 

Whatever the size or scope of your study, Provision provides the comprehensive clinical development services you need, from First-in-Human through Phase IV and post-marketing follow-through.

We also have the regulatory expertise, clinical trial operations management, payer and market access planning, medical education, and communications capabilities to see your journey through efficiently and effectively.

clinical studies
Provision FDA Clinical Studies Consulting Services:

  • ​Phase 1 - 4

  • Choosing CRO and universities

  • Protocols

  • FDA meetings

  • Clinical study-managing representative

  • Develop the clinical trial design

  • Determine sample size calculations

  • Write Statistical Analysis Plans (SAP) or Interim analysis plans (IAP)

  • Data management

  • Biostatistics

  • Clinical evidence and post-market studies

  • Draft regulatory agency, board meeting, or investor presentations of the clinical development, regulatory and/or statistical plan

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