Blog

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 Now, FDA provides draft guidance on ethically including kids in trials.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.

As the clinical trial industry has evolved in the past decade, it’s invited more complexity into operations and workflows.

Informed consent is a centrally regulated protection for research participants. Learn the regulatory requirements for providing it. 

Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.

Identifying the best prepared and performing sites for a study is essential to success. Explore strategies to improve site selection and feasibility.

Finding the best training solutions begins with understanding your organization’s training needs.

FDA released regulations in 1997 outlining how 21 CFR Part 11 applies to electronic records and electronic signatures in clinical research.