Blog

In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.

Uncover key regulations and insights regarding GxP in pharmaceuticals, medical devices, and clinical research.

A robust institutional HRPP plan includes a comprehensive compliance framework and experienced staff focused on protecting research participants.

Having a robust human research protection program (HRPP) in place is vital when maintaining compliance and keeping participants safe.

Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.

In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.

As FDA CBER prepares to launch Operation Warp Speed for Rare Diseases, there is an expected rapid growth in gene therapy.

Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.

Utilizing a comprehensive, site-centric eSource or electronic data capture (EDC) platform can streamline a site’s data capture, management, and compliance.

Learn the FDA's investigational device exemption requirements for clinical trials involving investigational in vitro diagnostic devices.

Find out which unexpected events you should report to the IBC during a clinical trial, and what to expect from the IBC's review.

Explore insights on new CMS policies & Medicaid's fresh clinical trial policy. Stay updated in a rapidly evolving healthcare landscape.