COVID-19 has left a trail of uncertainty in its wake as the burden weighing on pharmaceutical companies working to get their clinical trials back on track appears somewhat insurmountable. These challenges facing the pharmaceutical industry are multifaceted as the number of trials previously put on hold now looking to reconvene is compounded by the growing […]
The Time is Now. The pharmaceutical industry is laden with issues and inefficiencies that, as of late, have been illuminated and exacerbated. Much of the issue lies in the industry’s sluggish digital transformation as so many of the shortfalls that the system currently grapples with, would be largely improved with the assistance of technology. There […]
Great read on the latest COVID-related regulatory developments, namely the FDA’s announcement on treatment efficacy thresholds for upcoming vaccines. A week after the US Food and Drug Administration (FDA) issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and Research, shed light on the reasoning […]
With increased limitation in the capacity to develop, plan, and execute regulation-abiding clinical trials, there is growing concern surrounding the best tactics to proceed forward. The coronavirus pandemic has thrown a wrench into plans for hundreds of clinical trials. But some investigators and sponsors are pushing ahead. Source: Patients, drug makers grapple with cancer […]
MVG Insights In lieu of the COVID-19 outbreak, the FDA has issued 3 clinical guidances outlining new protocols related to the following: REMS requirements, alcohol-based sanitizer production, and the conduct of clinical trials of medical products. Each guidance resulted directly from the need for current protocol adaptation to address unmet needs due to COVID-19. 1. REMS […]
A look into Risk Evaluation and Mitigation Strategies (REMS) programs and how MVG can help. MVG Insights: REMS Monday, April 6, 2020 Risk Evaluation and Mitigation Strategies (REMS) programs were instituted as part of the FDA Amendments Act (FDAAA) in 2007 to provide safe access to products that may not otherwise be approved based on their […]
MVG is ready and able to assist in remote audits amongst travel restrictions caused by COVID-19. Amidst the evolving challenges resulting from the COVID-19 outbreak, MVG can offer remote solutions to ensure maintained efficiency. Remote offerings, to help keep your timeline intact: Trail Master File Audits Clinical Study Reports (CSR) Audits Internal Audits Vendor […]
Interesting read on the vaccine for COVID-19. While the speed at which Moderna has been able to progress their vaccine is impressive, it also raises many questions surrounding the bioethics of expediting such processes in the face of imminent need. Ethicists aren’t so sure that the eventual benefits of rushing this unproven vaccine into clinical […]
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Young biopharmaceutical companies go through a logical progression headed to clinical trials of the compounds that they have nurtured through discovery and research. Quality Systems in companies in their infancy are generally based on the principals of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Companies with GLP/GMP-based Quality Systems often are challenged by […]