Research Sponsors
IRBs and IBCs: Critical Partners in Gene Research
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Clinical Endpoints
DMC Regulations May Change, but Principles Won’t
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The Eligibility Conundrum in Clinical Trial Protocols: FDA Issues Workshop Report
Blog Posts
Written Procedures for IRBs: What Does the New Final Guidance from FDA and OHRP Mean to You?
Whitepapers
Clinical Endpoints
5 Benefits of Outsourcing Expert Committee Management to an Independent Provider
Solution Overviews
Clinical Endpoints
Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharrmacologic trials
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Use of Endpoint Adjudication to improve the quality and validity of endpoint assessment for Medical Device Development
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Clinical Endpoints
Responsibilities of Data Monitoring Committees: Consensus Recommendations
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Clinical Trial Safety
An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees
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