Regulatory Compliance
Clinical Endpoints
Comment on the revised FDA Industry Guidance for Early AD Drug Development: Implications for Clinical Outcomes Assessments
Blog Posts
Diversity & Inclusion
Preparing Updates to IRB and Recruitment Processes for the Upcoming FDA DEI Mandate
Blog Posts
Regulatory Compliance
Unpacking the FDA’s Guidance on Developing Drugs for Treatment in Pediatric Inflammatory Bowel Disease
Blog Posts
Regulatory Compliance
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications Guidance for Industry, IRBs, and Clinical Investigators
Blog Posts
Regulatory Compliance
Cancer Clinical Trial Eligibility Criteria: Performance Status Guidance for Industry, IRB, and Clinical Investigators
Blog Posts
Regulatory Compliance
Why do Community Members Need to Participate in IBC Review Meetings?
Blog Posts
Ethics in Clinical Research
Demystifying FDA Processes: Why Do Changes in Regulations Take so Long?
Blog Posts
Ethics in Clinical Research
Review of Emergency Research
Whitepapers
Diversity & Inclusion
FDA Guidance and Revised OMB Guidance on the Collection of Race and Ethnicity Data
Blog Posts
Clinical Trial Safety