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MVG Consulting Featured News

Celebrating 25 Years of MVG Consulting!

August 18th, 2023 | Featured

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 […]

The Evolution of FDA Recommendations on Real World Evidence and Real World Data

August 29th, 2022 | Featured

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 […]

CROs are Failing Small Biotech and Pharmaceutical Companies: Smaller Consulting Firms are Picking Up the Slack

August 1st, 2022 | Featured

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 […]

Trending Clinical 483s from FY 2021: How You Can Improve Your Inspection Readiness

February 18th, 2022 | Featured

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 […]

Updates to the ICH E6 Guidelines Are Coming Soon: Are You Prepared?

January 7th, 2022 | Featured

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) […]

Transparency Builds Trust: The Fight to Vaccinate the Unwilling

August 18th, 2021 | Featured

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 […]

With Demands for Additional Data, the FDA Pauses Merck’s MK-7110 Summer Rollout

August 9th, 2021 | Featured

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 […]

Novel Retinal Disease Treatments? Iveric Bio Begins the Search for Potential Gene Therapies

August 4th, 2021 | Featured

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 […]

The Impact of the Immune System: How studying the immune reactions to COVID-19 will help scientists to develop more effective vaccines

July 27th, 2021 | Featured
clinical operations

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 […]

The Impact of the Immune System: How studying the immune reactions to COVID-19 will help scientists to develop more effective vaccines

July 21st, 2021 | Featured

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 […]

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