Sponsors
Decentralized Clinical Trials Involving Biologics: Unique Challenges
Find out what FDA says about decentralized clinical trials and biologics, and what this means in practice.
From Simulation to Success: Stress Testing Your Inspection Readiness
Gain expert insights, best practices, and strategies to navigate FDA inspections with confidence.
Medicare Coverage Analysis in Oncology Trials
This webinar will cover the overall benefits of performing a Medicare coverage analysis, including important criteria to consider.
Overseeing and Operationalizing Patient Recruitment Across Study Stakeholders
This webinar for sponsors and CROs will tackle the most pressing challenge in clinical research: achieving enrollment targets on time.
Good Manufacturing Practices: When Do They Apply?
Ensure product quality and compliance in the drug development process. Learn how to optimize your manufacturing processes and maintain key regulatory standards with cGMP best practices from experts.
Conducting Research With CAR T Cells
This white paper is a guide for research professionals looking to conduct CAR T cell studies for the first time, as well as for those seeking to expand their existing portfolio.
4 KPIs Clinical Research Study Managers Can Master
This white paper examines four KPIs most impacting timelines and budgets and offers strategies for effective communication and risk mitigation.
Single IRB Review: Tips for Sponsors and CROs Working with Institutional Sites
This eBook provides a toolkit to understand the institutional review board's role when sIRB review is utilized.
GxP Audits Guide for Successful Clinical Trials
Ensure GCP compliance throughout your clinical research lifecycle with a comprehensive guide to GxP audits.
Key Items Auditors Look for When Reviewing an Investigator Site File
Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:
Not if, but When: A Study Manager’s Guide to Adaptability and Incoming Trends
Dive into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.
Understanding FDA’s 2024 Draft Guidance on DMCs
Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.