This post is sponsored by IMARC Research, Inc. Since the August 2011 release of the draft guidance document by the FDA on a risk-based approach to monitoring, there has been a lot of buzz in the ...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(BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring ...
The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring strategies for clinical investigations ...
Environmental Monitoring Performance Qualifications (EMPQs) are a critical milestone in cleanroom qualification, yet they ...
Organizations are integrating previously disparate services to better align their offerings with the shift from fee-for-service to risk-based care through visionary, member-centric solutions. For ...
A quantitative approach for linking baseline sample size to statistics provides a statistically justified basis for ...
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 ...
Agricultural commodities used for feed and food production are frequently contaminated with mycotoxins, such as Aflatoxin B1 (AFB1). In Europe, both the government and companies have monitoring ...
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 ...
The financial sector is moving beyond exclusively calendar-based reviews toward perpetual Know-Your-Customer (pKYC) monitoring. As automation and AI evolve stronger real-time capabilities, the US, EU, ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results