MVG Insights
Providing clinical development insight to the biotechnology and pharmaceutical industries
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Fully customized, high quality and cost-effective drug development and clinical trial management services.
MVG Consulting has helped biotech and pharmaceutical clients succeed in all phases of project development and clinical research for over twenty years. MVG Consulting can help you choose the best suited CRO alternative for your clinical study management needs.
During clinical development of a product, MVG helps incorporate strategies for a successful inspection.
We believe that inspection readiness should be laid into the groundwork of all processes of clinical development. As such, we incorporate multiple strategies to achieve this, including: –Standard Operating Procedures –Monitoring procedures and activities –Clinical...
Keeping an Inspection Readiness mindset throughout your clinical development program increases the odds of a successful inspection.
Our experience has been that many clients think about inspection readiness when an inspection is imminent due to the filing of a marketing application. However, we believe that inspection readiness should be part of the project at all phases. When we start a project...
Good clinical practice requires high standards
MVG Consulting Clinical Quality Assurance (CQA) services help our clients ensure the integrity of their clinical trials. The CQA audits we conduct include: clinical investigator site audits, working with sites to prepare for regulatory agency inspection, conducting...
What do you do when your studies have been mismanaged by a CRO?
Sometimes, things just don’t work out. When you reach an impasse with your CRO, when proper planning isn’t done, when the “A” team you were promised at the kick off meeting becomes the “B” or the “C” team, you need to rescue what you can, and return your project to...
Managing your Contract Research Organization
If you have limited resources internally and need the services of a full service CRO, MVG Consulting can help manage the CRO for you via “Managed CRO Services.” We provide high level consultants who seamlessly integrate with your internal team, providing you with the...
MVG Consulting Services provides custom quality solutions for clinical development.
MVG has been providing Clinical Operations, Clinical Monitoring, Clinical Project Management, Clinical Quality Assurance, Data Management, Medical Writing and S.O.P. Development solutions since 1998. Our highly qualified clinical research professionals seamlessly...
MVG Consultants provide expertise in many therapeutic indications.
Hematology Oncology Vaccines Antiinfectives Cardiovascular Pain Management Infectious Disease Inflammation Women’s Health Neurology Rare Diseases Endocrinology
Inspection Readiness should be built into all processes during clinical development.
Good planning at the beginning of the program can lessen, or even prevent, many of the issues found during an inspection. Let MVG Consulting conduct an analysis of your existing program. Keeping inspection readiness in mind through the entire program will help...
MVG Consulting conducts several important clinical quality assurance audits.
Clinical investigator site audits Work with high enrolling sites to prepare them for possible regulatory agency inspection Conduct GAP analysis for sponsors to assess their systems and procedures to ensure compliance with applicable regulations Clinical database...
Clinical Research Operations are a critical component in all studies.
From start to finish, our highly-skilled clinical operations consultants ensure proper planning, study conduct, patient safety and data quality. MVG Consulting Clinical Trial Managers provide leadership and operational expertise through collaborative planning,...
Many biopharmaceutical companies are adopting a “hybrid” approach to clinical study management.
In this model, you choose which services to outsource to a CRO and which services you will manage through vendors of your choosing. MVG Consulting can provide contract staff to help manage the various vendors in use during a study. We can also help in the search for...