CROs

Cell & Gene Therapy
Addressing the Challenges of Human Tissues and Cell Products Regulation
Whitepapers
IRBs and IBCs: Critical Partners in Gene Research
Articles
Clinical Endpoints
DMC Regulations May Change, but Principles Won’t
Articles
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
Articles
Use of Endpoint Adjudication to improve the quality and validity of endpoint assessment for Medical Device Development
Articles
Clinical Endpoints
Responsibilities of Data Monitoring Committees: Consensus Recommendations
Articles
Clinical Trial Safety