Blog

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.

HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.

Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.

Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.

FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.

An important decision impacting a multi-faceted study startup process is determining which sites to partner with for study conduct.

Ethical oversight committees continue to innovate to keep pace with the rapid changes and evolution of research conduct.

ALCOA ensures source data is safe and effective, but how does it differ for data collected on paper vs. electronically?

While clinical trial site selection aids in a trial’s success, it’s critical to maximize the study's time, resources, and funds.