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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.

Sickle cell disease significantly impacts the African American population, a minority community historically underserved by clinical research.

Optimizing Your Data Management Plan: Best Practices for Biomedical Research under the NIH Data Sharing Policy

This series celebrates the groundbreaking achievements of four pioneers who defied the odds to change the course of clinical research forever

Trial designs incorporating multiple endpoints to support efficacy are receiving increased focus from the FDA, including a recently published guidance.

Measuring IRB quality is often an effort to determine whether an IRB’s actions improve research participant protections.

Medicare coverage analysis evaluates how clinical research protocol items and services are billed per federal agency guidelines.

As the industry continues to shift from brick-and-mortar trials to more convenient hybrid formats, eConsent proves to be useful.