Risk Evaluation and Mitigation Strategies (REMS) programs are required by the US FDA to monitor certain medications that have high potential for serious adverse events. The FDA determines if a REMS is necessary during the approval process for a new product and if deemed necessary, the drug company is responsible for developing and maintaining the REMS […]
Introduction A recent draft guidance from the FDA provides clarity on how protocol deviations can better be defined, identified and reported in clinical investigations. Because the term “protocol deviation” is not explicitly defined in FDA regulation, the guidance directs sponsors, clinical investigators and institutional review boards (IRBs) to what constitutes a deviation and how best […]
What is ICH E6? It is the International Council for Harmonization’s (ICH) guideline for Good Clinical Practice (GCP). The guideline establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants. The Guidance is centered on its Principles, which provide a high-level, flexible framework for conducting a clinical trial and are supplemented […]
Join us in commemorating this wonderful milestone in our company’s history as we officially reach 25 years in business. 25 years is a long time, and not only has MVG changed drastically in that time, but so has the industry overall. Take a look at some of the key changes that have occurred during MVG’s […]
Following the 21st Century Cures Act, passed in 2016, which aims at accelerating the development of medical products to allow innovation to reach patients more efficiently, the use of Real World Evidence (RWE) and Real World Data (RWD) has become increasingly impactful. This increased importance stems from the potential use of RWE by regulatory bodies […]
In the last decade, the role of CROs has become increasingly integral to clinical trials, with smaller companies often outsourcing the vast majority of their services to these firms. However the growing need for CRO services has placed demand on these companies, many of whom are cracking under the pressure. Additionally, post-Covid staffing issues have […]
Every year, the FDA publishes records of the 483s issued during inspections, which provides a snapshot of the most prevalent inspection observations across the industry. Bioresearch Monitoring (BIMO) enforcement statistics relate directly to sites, sponsors, and vendors within clinical trials. As shown in the pie chart below, over 70% of all findings relate to protocol […]
One of the most important and often under-resourced aspects of clinical trials is vendor selection, management and oversight. If vendor management isn’t a top priority, it should be, as the FDA places large significance on this area, as is evidenced by the most recent updates to the Bioresearch Monitoring (BIMO) Program. The Bioresearch Monitoring (BIMO) […]
Change has been abundant over the last year and a half, as COVID-19 has forced adaptations in all facets of life. When it comes to the maintenance and compliant execution of clinical trials, the largest adjustment has been the integration of new solutions to ensure that trials can move forward. With patients sometimes unable to […]
As desperation grows to get unwilling people vaccinated, researchers find that the answer may very well lie in being more directly transparent with their clinical data. If people are welcomed to see the research and results surrounding the vaccines they are being asked to take, it may help to shift the tide. Transparency of this […]