MVG Consulting Services

MVG Consulting Services MVG Consulting Services helps small to medium sized biotechnology and pharmaceutical companies with their clinical development program needs. Local Business

Join us in commemorating this wonderful milestone in our company’s history as we officially reach 25 years in business. ...
08/18/2023

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 […]

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 MV...

Following the 21st Century Cures Act, passed in 2016, which aims at accelerating the development of medical products to ...
08/29/2022

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 […]

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 ste...

One of the most consistent FDA inspection findings in the last few years has revolved around inadequate processes, a key...
08/18/2022

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 team works closely with clients to ensure their Standard Operating Procedures […]

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 team works closely with clients to ensure....

In the last decade, the role of CROs has become increasingly integral to clinical trials, with smaller companies often o...
08/01/2022

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 […]

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 p...

Every year, the FDA publishes records of the 483s issued during inspections, which provides a snapshot of the most preva...
02/18/2022

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 […]
The post Trending Clinical 483s from FY 2021: How You Can Improve Your Inspection Readiness first appeared on MVG Consulting Services.

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 sh...

One of the most important and often under-resourced aspects of clinical trials is vendor selection, management and overs...
01/14/2022

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) […]

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 Mo...

The ICH E6 Good Clinical Practice (GCP) Guideline, the current global standard for clinical trials, is estimated to have...
01/07/2022

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) […]

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 foc...

Change has been abundant over the last year and a half, as COVID-19 has forced adaptations in all facets of life. When i...
09/20/2021

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 ex*****on 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 […]

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 ex*****on of clinical trials, the largest adjustment has been the integration of new solutions to ensure that trials can move forward. With...

As desperation grows to get unwilling people vaccinated, researchers find that the answer may very well lie in being mor...
08/18/2021

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 […] The post Transparency Builds Trust: The Fight to Vaccinate the Unwilling first appeared on MVG Consulting Services.

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....

When Merck purchased OncoImmune to gain control of the experimental treatment for COVID-19, and shortly after signed a $...
08/09/2021

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 positive trial data, the FDA is demanding that there be more evidence of […] The post With Demands for Additional Data, the FDA Pauses Merck’s MK-7110 Summer Rollout first appeared on MVG Consulting Services.

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 positive trial data, the FDA is....

To help tackle the difficulty of finding treatments for retinal diseases, Iveric Bio has established the “Gene Therapy I...
08/04/2021

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 comprised of a specialized group of experts, all of whom focus in a specific niche. The committee is centrally […]

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 comprised of a specialized grou...

As the first round of approved vaccines makes its’ way into arms around the world, scientists are still working tireless...
07/27/2021

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 between cells infected with SARS-CoV-2 and the human immune system. Studying these […]

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 between cells infected with SARS-C...

Address

400 Washington Street Suite 410
Braintree, MA
02184

Telephone

+17818435491

Website

Alerts

Be the first to know and let us send you an email when MVG Consulting Services posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Contact The Business

Send a message to MVG Consulting Services:

Shortcuts

Share

Category