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Clinical Study Execution & Oversight

FRC offers coordinated, collaborative and customized clinical study oversight to deliver timely results and high-quality data that meets regulatory compliance. Our dedicated team of experts provides strategic thinking to ensure solution-oriented approaches to study challenges. Strong oversight of your CRO and/or the clinical sites enables us to evaluate each individual study and to recommend central, onsite, or risk-based monitoring, or a combination of the three, in order to improve the effectiveness and efficiency of monitoring.

We will prepare your study plans and study logs, and will draft and finalize your ICF for IRB submission. We will also collaborate with you and your team on product label development.

FRC is instrumental in overseeing the design and testing of your electronic data capture system for data management processes. From designing and reviewing case report forms and edit check specifications to identifying external edit check requirements to reconcile external data with the EDC data, FCR will ensure your systems are thorough and set-up to achieve robust data integrity. FCR will fully test the EDC system prior to launch and will help coordinate notification alerts during use of the system.

FCR can design or review your statistical analysis plan, making sure the efficacy and safety reporting are accurately designed. FCR will review the statistical results to confirm the validity of the TLFs prior to summarization within the clinical study report, and will also review the CDISC datasets and supporting documentation.

FCR will coordinate the authorization of your clinical study reports with an experienced medical writer experienced in the therapeutic indication under study. Medical writing will follow ICH guidance and will be fully reviewed by FCR prior to submission to the sponsor to confirm accuracy to speed up finalization.

We will provide you with dedicated and unrivaled support throughout the drug development process.

Talk to us about your Clinical Study Oversight needs.

Development/Review of Study Plans &Logs
Study Plan
Communication Plan
Monitoring Plan
Site Logs
Site Training
Delegation of Authority
IRB Approved Ads
Subject screening
Subject enrollment
IP Dispensing
IP Return
Site Termination Letter
Data Management Plans
Statistical Analysis Plan
Data Management Systems Design
Case Report Forms Design
Edit Check Specifications
User Acceptance Testing
CRF Completion Guidelines
Subject Diaries (internal/external to EDC system)
Data Tracking
Biometrics Reports
Statistical Analysis Review
Tables, Listings, Figures
Dataset Design (CDISC)
Annotated Casebook
Define Documentation
Reviewer's Guide
Clinical Study Report Review
CSR Shell
CSR Report including Required Appendices