Safety Monitoring
The Power of Worldwide Networks in Data and Safety Monitoring Boards
Find out why regulatory agencies prefer diverse, global expertise for DMC reviews, plus the numerous benefits of DMC experts representing international perspectives.
Decentralized Clinical Trials Involving Biologics: Unique Challenges
Find out what FDA says about decentralized clinical trials and biologics, and what this means in practice.
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.
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.
CAR T Manufacturing and Toxicity
Find out what FDA guidance says about integrating gene delivery vectors, such as CAR T cells, and gene editing technologies (like CRISPR).
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.
What Does an Endpoint Adjudication Committee (EAC) Do?
This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.
Patient Recruitment and Enrollment in Clinical Trials
Learn more about patient recruitment and enrollment: how they find out about clinical trials and the reasons they participate.
Considerations for IRB Review: Artificial Intelligence & Machine Learning
Read this blog to learn IRB review considerations for artificial intelligence and machine learning studies.
Video: Introduction to Data Monitoring Committees
More studies now require oversight than ever. DMCs are required when a trusted independent third party is necessary to assess clinical trials
When do I Need a DMC?
View our infographic to learn the basics of a data monitoring committee (DMC), also referred to as data safety monitoring board (DSMB).
Ethical Issues in the Design and Review of Decentralized Research
This white paper aims to provide a framework to understand ethical issues and steps to take in deploying a decentralized trial
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