MVG Insights
Providing clinical development insight to the biotechnology and pharmaceutical industries
Featured News:
Celebrating 25 Years of MVG Consulting!
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...
The Evolution of FDA Recommendations on Real World Evidence and Real World Data
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...
CROs are Failing Small Biotech and Pharmaceutical Companies: Smaller Consulting Firms are Picking Up the Slack
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...
Trending Clinical 483s from FY 2021: How You Can Improve Your Inspection Readiness
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...
Updates to the ICH E6 Guidelines Are Coming Soon: Are You Prepared?
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...
Transparency Builds Trust: The Fight to Vaccinate the Unwilling
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...
With Demands for Additional Data, the FDA Pauses Merck’s MK-7110 Summer Rollout
When Merck purchased OncoImmune to gain control of the experimental treatment for COVID-19, and shortly after signed a $356 million dollar government contract to deliver 100,000 doses by the summer, it was assumed that Merck would be able to deliver. However, despite...
Novel Retinal Disease Treatments? Iveric Bio Begins the Search for Potential Gene Therapies
To help tackle the difficulty of finding treatments for retinal diseases, Iveric Bio has established the “Gene Therapy Inherited Retina Disease Scientific Advisory Committee” to help translate research findings into actionable, clinical solutions. The committee is...
The Impact of the Immune System: How studying the immune reactions to COVID-19 will help scientists to develop more effective vaccines
As the first round of approved vaccines makes its’ way into arms around the world, scientists are still working tirelessly to find improved vaccines for years to come. One key avenue through which scientists are looking to make improvements is in the interactions...
The Impact of the Immune System: How studying the immune reactions to COVID-19 will help scientists to develop more effective vaccines
As the first round of approved vaccines makes its’ way into arms around the world, scientists are still working tirelessly to find improved vaccines for years to come. One key avenue through which scientists are looking to make improvements is in the interactions...
MVG News:
Celebrating 25 Years of MVG Consulting!
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...
The Evolution of FDA Recommendations on Real World Evidence and Real World Data
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...
Are Your SOPs Inspection Ready?
One of the most consistent FDA inspection findings in the last few years has revolved around inadequate processes, a key aspect of which is SOP infrastrcuture. At MVG, ensuring our clients have a robust, inspection-ready suite of SOPs is a top priority. Our...
CROs are Failing Small Biotech and Pharmaceutical Companies: Smaller Consulting Firms are Picking Up the Slack
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...
Trending Clinical 483s from FY 2021: How You Can Improve Your Inspection Readiness
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...
Vendor Management Takes Center Stage in the Most Recent BIMO Updates
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 ICH E6 Guidelines Are Coming Soon: Are You Prepared?
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...
In-Home Clinical Trials Are Here to Stay
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...
Transparency Builds Trust: The Fight to Vaccinate the Unwilling
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...
With Demands for Additional Data, the FDA Pauses Merck’s MK-7110 Summer Rollout
When Merck purchased OncoImmune to gain control of the experimental treatment for COVID-19, and shortly after signed a $356 million dollar government contract to deliver 100,000 doses by the summer, it was assumed that Merck would be able to deliver. However, despite...
Novel Retinal Disease Treatments? Iveric Bio Begins the Search for Potential Gene Therapies
To help tackle the difficulty of finding treatments for retinal diseases, Iveric Bio has established the “Gene Therapy Inherited Retina Disease Scientific Advisory Committee” to help translate research findings into actionable, clinical solutions. The committee is...
The Impact of the Immune System: How studying the immune reactions to COVID-19 will help scientists to develop more effective vaccines
As the first round of approved vaccines makes its’ way into arms around the world, scientists are still working tirelessly to find improved vaccines for years to come. One key avenue through which scientists are looking to make improvements is in the interactions...