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 […]
The connection between MVG and our data management/biostatistics partners allow us to provide data management & biostats services to our clients, such as statistical programming, data collection, data management and data integration.
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