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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 […]

The Evolution of FDA Recommendations on Real World Evidence and Real World Data | MVG Consulting Services 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...

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 […]

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

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

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) […]

Updates to the ICH E6 Guidelines Are Coming Soon: Are You Prepared? | MVG Consulting Services 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...

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.

Transparency Builds Trust: The Fight to Vaccinate the Unwilling | 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....

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 […]

Novel Retinal Disease Treatments? Iveric Bio Begins the Search for Potential Gene Therapies | MVG Consulting Services 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...