MVG Insights
Providing clinical development insight to the biotechnology and pharmaceutical industries
Featured News:
Are You Paying More For Good Talent Than You Should? Maybe It’s Time To Try Contract Work
When it comes to hiring the right talent to help a company succeed, the tradition has typically been to hire full-time talent that can be groomed to the culture and processes of a specific firm. However, investing in full time employees is costly, and doesn’t always...
Are you prepared for the “new normal”?
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...
Regulatory Science Clinical Research Where Do We Stand (And Where Are We Going)
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...
Marks on COVID-19 vaccine efficacy, EUAs and challenge trials | RAPS
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...
Patients, drug makers grapple with cancer clinical trials during coronavirus
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...
FDA Issues New Guidances in Response to COVID-19.
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...
Risk Evaluation and Mitigation Strategies (REMS) Programs & MVG
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...
COVID-19: How MVG Consulting Can Assist Remotely
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...
Coronavirus Vaccine Clinical Trial Starting Without Usual Animal Data
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...
MVG is Hiring – Clinical Trial Managers
Are you a Clinical Trial Manager, Clinical Project Manager, or Medical Writer looking for your next career move? Contact MVG today with job inquiries!
MVG News:
We are Hiring – Open Contractor Positions at MVG Consulting
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!
Are you prepared for the “new normal”?
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...
A Covid-19 vaccine, amazingly, is close. Why am I so worried? – STAT
While the speedy development of a COVID-19 vaccine lends itself to a faster “return to normal”, the expedience raises some very legitimate concerns about the quality of such a rushed product. Due to the immense pressure to approve a vaccine quickly, a subpar and...
Regulatory Science Clinical Research Where Do We Stand (And Where Are We Going)
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...
Marks on COVID-19 vaccine efficacy, EUAs and challenge trials | RAPS
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...
Ways to Maintain Efficiency During the Work From Home Era
While much of the world remains on pause, drug development processes struggle to remain active and compliant, urging the need for alternate methods to keep things moving forward. Now more than ever, it is important to leverage the tools already equipped to function...
Patients, drug makers grapple with cancer clinical trials during coronavirus
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...
COVID-19 Beckons a New Area for Clinical Trials
When the effects of COVID-19 took root in the US, a shift away from typical routines was triggered, one which brought far reaching repercussions. In all areas of life, this pandemic has forced change, no matter the feasibility of adapting to such change. Where...
Next Generation Of COVID-19 Virus Tests Could Get Faster And Cheaper With CRISPR : Shots – Health News : NPR
As the demand for COVID-19 testing continues to outpace supply, CRISPR emerges with innovative and promising potential to fill that gap. Researchers are racing to develop quick, home-based tests for the virus that could deliver test results in minutes. None do...
FDA Issues New Guidances in Response to COVID-19.
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...
Risk Evaluation and Mitigation Strategies (REMS) Programs & MVG
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...
COVID-19: How MVG Consulting Can Assist Remotely
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...