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

MVG 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.

They accomplish this in multiple ways–by being flexible to the scope of the project, by using our expertise to guide through the clinical data and by demonstrating the efficacy of the drug and by improving patient safety.

Our knowledgeable and multilingual clinical quality assurance (CQA) auditors are well versed in local, national and international regulations, standards and guidelines.

Development of SOPs (Standard Operating Procedures) Study & site startup activities Documents and Submissions IRB/IEC interaction Contracts & budgets Screening and enrollment Study subject activity throughout the trial Regulatory documents (electronic and hard-copy) Monitoring Visit Reports, calendars and schedules Safety Reporting

MVG clinical research associates work closely with your team on protocol and indication training, building strong site relationships and ensuring site compliance.

MVG provides companies alternatives to the large contract research organizations, helping small to medium sized biotechnology and pharmaceutical companies with their clinical development programs.

Let MVG Consulting help you with this process and get sites and vendors ready for regulator agency inspections. MVG can help with: Preparation of Common Technical Document sections Preclinical CMC Clinical Assessment of inspection readiness for sites and vendors Inspection Readiness Training Mock inspections at sponsor, sites and vendors Planning post-marketing commitment studies

The old adage is true; we don’t live in a perfect world, and even the most carefully planned project can hit a bump in the road. MVG’s “project rescue” boasts a solid track record, using a well-proven model, to bring projects back on track. Our experienced consultants can address the most challenging situations.

In today’s connected world, many successful companies have personnel scattered across the country, and MVG has provided, and continues to provide, when needed, entire project teams to start-ups and virtual companies in need of highly qualified clinical research professionals.