This post is sponsored by IMARC Research, Inc. In a recent blog post, we provided an overview of the “Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring” ...

Risk-based monitoring (RBM) is an evolving concept in the clinical trial industry that is transforming the ways trials are done. So what is risk-based monitoring? We had a chance to speak with Andy ...

Monitoring risk is certainly not a new concept in healthcare. There are countless treatment protocols and care pathways designed to mitigate risks for patients and making their treatment safer. More ...

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 ...

New offering improves the quality and predictability of clinical development while reducing overall trial costs by up to 25 percent RESEARCH TRIANGLE PARK, NC – Quintiles today announced the launch of ...

Over the last 10 years, clinical trials have changed substantially in response to increasing globalization and study complexity, along with new technological capabilities and industry guidelines 7.

What is Risk-based Monitoring? RBM is an adaptive approach to clinical trial monitoring that directs monitoring focus away from being indiscriminate (let’s collect a lot of data and monitor everything ...

NEW YORK--(BUSINESS WIRE)--Medidata (NASDAQ:MDSO), a leading global provider of cloud-based solutions for clinical research in life sciences, and Pharmaceutical Product Development, LLC (PPD), a ...

Pharmaceutical companies and clinical research organizations (CROs) that adopt risk-based monitoring (RBM) in their clinical development programs often ask what a normal day or normal week will look ...

Today I continue my exploration of risk in compliance by starting a consideration of risk-based monitoring. As I have the previous two days, I honor a television star who died last week and today it ...