Blog

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.

New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.

With cannabis usage becoming more popular, there’s an uptick in research surrounding its therapeutic effects.

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

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.

What happens when an unexpected non-English speaking participant shows up, and there isn’t enough time to obtain a translated study consent?

Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools

Research into participant experiences has consistently shown their desire to learn the results of research to which they’ve contributed.