Blog

Data safety monitoring boards (DSMBs) ensure research participants are protected and results are valid. Learn about DSMB composition, concerns, charter, and challenges.

Discover the role of MCA in clinical research, its impact on study activation timelines, and how outsourcing can streamline trials.

Key strategies for successful research study startup: site selection, documentation, and effective initiation.

Find out how sites can get the most value from their clinical trial management system (CTMS) to streamline operations.

Learn practical strategies on how to improve diversity in clinical trials for historically under-represented groups.

If an investigational in vitro diagnostic (IVD) device is used in clinical research, it may require IRB review.

Discover how CTMS streamlines patient recruitment & management for successful clinical trials.

Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.

The proposed single IRB mandates will impact FDA-regulated research, potentially altering existing practices at organizations.

Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.

FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.

Using an eRegulatory system can benefit any site, helping to increase productivity, improve compliance, and save money.