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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.

Endpoint adjudication committees must keep up with rapidly developing requirements as they receive potentially identifiable research data.

A valuable tool for both sites and participants, now is the right time for sites to adopt an eConsent platform.

Proper trial financing ensures internal costs are covered, facilitates better negotiation, and leads to higher compliance in trials.

More governing bodies are starting to opt for single institutional review board (sIRB) review as a way to streamline research operations.

Determine whether your trial meets the requirements of the National Coverage Determination (NCD) for Routine Costs in Clinical Trials.

sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.