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 […]
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 […]
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) […]
The ICH E6 Good Clinical Practice (GCP) Guideline, the current global standard for clinical trials, is estimated to have its public draft version of the third revision (known as “R3”) published this month, January of 2022. The primary change that can be expected in the newest revision is the focus on quality by design (QbD) […]
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 […]
Looking for new consulting work? Check out our open contractor positions at MVG: Manager of Clinical Quality Systems Clinical Quality Assurance Auditor Clinical Trial Manager Clinical Project Manager Medical Writer Contact MVG today with inquiries!
COVID-19, and its disproportionate effect on minority populations highlighted the need for increased diversity in clinical trials in order to adequately treat every patient population. The biopharma industry has resisted diversification in the past because its infrastructure breeds success in working within non-diverse populations. However, 2020, changed things, and the urgency to improve diversification is […]
Once a seemingly far-fetched endeavor, decentralized clinical trials are gaining favor in the wake of COVID-19. It has become clear that the time for entirely in-person clinical trials has passed, paving the way for a new, technologically integrated approach. This next year will be exceptionally telling as telemedicine and mobile health tracking continue to drive […]
At the end of this uniquely challenging year, MVG Consulting would like to take a moment to thank those who have had an indelible impact throughout this difficult time. To the frontline workers, who have worked tirelessly, adapting to every changing circumstance this pandemic has forced upon us. To those working remotely, who have had to […]