Regulatory Compliance
Ethics in Clinical Research
The FDA’s Guidance on Electronic Records and Signatures: Key Takeaways
Blog Posts
Ethics in Clinical Research
Navigating Ethical Challenges: Research with Adults Lacking Capacity to Consent
Whitepapers
Artificial Intelligence and Machine Learning in Clinical Trials
The Role of AI in Regulatory Decision-Making for Drugs & Biologics: the FDA’s Latest Guidance
Blog Posts
Ethics in Clinical Research
The FDA Accepts ICH E11A on Pediatric Extrapolation: How Does This Impact Your Pediatric Study?
Blog Posts
Hybrid & Decentralized Trials
Decentralized Trials: Thoughts for Sponsors, Investigators, and IRBs
Blog Posts
Ethics in Clinical Research
Compounded Drugs in Research: Navigating IND Exemptions and Current Regulations
Blog Posts
Ethics in Clinical Research
Answering FAQs on HIPAA & PHI: Protect Participants’ Privacy & Ensure Compliance
Blog Posts
Ethics in Clinical Research
The Upcoming sIRB Mandate and the Critical Role of Site Selection: Your Questions Answered
Blog Posts
Clinical Endpoints
Comment on the revised FDA Industry Guidance for Early AD Drug Development: Implications for Clinical Outcomes Assessments
Blog Posts
Diversity & Inclusion