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 clinical trials are concerned, the adjustment has proven difficult, while […]

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 that yet, but several under development hold promise, scientists say. Source: Next Generation […]

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 resulted directly from the need for current protocol adaptation to address unmet needs due to COVID-19. 1. REMS […]

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 safe access to products that may not otherwise be approved based on their […]

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 your timeline intact: Trail Master File Audits Clinical Study Reports (CSR) Audits Internal Audits Vendor […]

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 sure that the eventual benefits of rushing this unproven vaccine into clinical […]

This includes ensuring that your SOPs: –Are uniformly written with detailed instructions to record routine operations, processes and practices followed within a business organization –Contain adequate detail to clearly guide research staff through a particular procedure –Are aimed at a specific procedure but be written in a general format that can be easily followed so […]

MVG Consulting offers what some biopharmaceutical companies call a hybrid model approach to clinical study management that protects the sponsor from an under-performing full service CRO.

With MVG Consulting providing the all-important final piece, your clinical research project can achieve its objectives.