Clinical Study Planning

FRC believes in proactive planning through the use of best practice guides, tools, templates and automated workflows for study startup. We drive quality, efficiency, and compliance while reducing risk and cycle time. Today’s aggressive timelines and need for high-quality data mean that you need partners you can count on to deliver timely and efficient results.

Getting it right from the start is the key to passing regulatory audits, inspections and improving the overall study quality. Our clinical study planning process includes study feasibility assessment through evidence-based methodology, followed by an assessment of enrollment goals.

Research suggests that 80% of all clinical trials fail to meet enrollment goals. For this reason, identifying and selecting the best sites for the trial is critical to clinical enrollment success.

We provide solution-focused project management to ensure that site engagement and participation is optimized.

Our clinical study planning services support the full lifecycle of a compound, small molecule, biologic, biosimilar, or device from entry into clinical development through launch and into late phase.

Contact us for a confidential review of your clinical study planning needs.

Study budget and forecasting
Selection of Vendors
Site Recruitment Assistance
Data Management (EDC) systems provider
Statistical Analysis
Medical Writing
eCTD compilation and submissions
Site Selection/Documents
Review of Site CDAs
Site CTAs
Site LOIs
Site Insurance Certificates
Site CVs
Protocol Signature Page
Financial Disclosure
Debarment Certificates
IRB Approvals