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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.

Medical device manufacturers are facing increasingly complex pathways to successfully bring their innovative ideas to the market.

Care must be taken to avoid sharps-related injuries and exposures when preparing investigational products for clinic transportation.

If any part of your informed consent process involves an electronic component, you’re conducting eConsent.

By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.

The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.

Sponsors are uncertain about how to design a DCT to ensure efficient performance delivery, learn how to set your organization up for success.

Using hoods with biological materials depends on directional airflow, and specialized airflow is necessary when handling hazardous materials.