This post is sponsored by IMARC Research, Inc. Since the August 2011 release of the draft guidance document by the FDA on a risk-based approach to monitoring, there has been a lot of buzz in the ...

In this free webinar, gain insight into the key elements to reduce risk for clinical trials. Attendees will learn how Independent Review and Data Analytics in eCOA strengthen endpoint integrity and ...

Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring ...

Following the release of five guidances to broaden cancer clinical trial eligibility earlier this week, the US Food and Drug Administration (FDA) is out with draft guidance Thursday on the risk-based ...

Clinical trials can often take between six and seven years to complete, but that timeline isn’t always practical for the problems pharmaceutical companies are trying to solve. Additionally, six years ...

The American Gastroenterological Association (AGA) today released a new clinical practice guideline on the surveillance of Barrett's esophagus, the only known precursor to esophageal cancer ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s ...

Regulators require that financial services companies take a risk-based approach (RBA) to maintain compliance, which can seem like a heavy burden on businesses in terms of costs, workforce and ...

When it comes to credit risk monitoring, many banks find themselves falling behind the regulatory expectations. Regulators are expecting banks to take a more proactive approach, using forward-looking ...