Case Studies
Success That Matters
We pride ourselves in providing our clients with fully customized, high quality and cost effective solutions to meet all of their needs.
Our drug development and clinical trial management services have helped numerous clients during all phases of project development.
Training/Controlled Document Management
A small biotech client originally contracted with MVG to provide clinical SOP writing services and to assist in developing/coordinating a paper-based training program. As work on the project progressed, the MVG Consultant was requested to expand their role by taking over the responsibility for coordinating the training program, managing the paper-based Controlled Document system, and providing support in other areas of the quality management system.
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A year later, a QMS Manager was onboarded and the MVG Consultant was retained as a direct report to the new manager which benefited the client by providing essential historical knowledge and continuity in the management of the training/Controlled Document systems, as well as fulfilling the need for an additional resource in support of QMS activities.
Subsequently, the company decided to transition to an EDMS for training and Controlled Document management. The MVG Consultant served a key role as a Subject Matter Expert and team member in the EDMS transition process and was involved in all aspects of the transition including provision of the appropriate documentation and training requirements for transition , writing SOPs/guidance manuals for the new processes, and training staff on the use of the system.
The transition to the EDMS was successful and shortly thereafter, the client merged with another company. Through the transition between the companies, the MVG Consultant was asked to continue providing QMS support services to the new company. As a result, the Consultant has currently provided 3+ years of valuable service to the client.
REMS Project Management
A client with a complicated REMS program for a rare disease treatment called upon MVG for support in managing their REMS Program. For this somewhat complex REMS Program with ETASU, the project initially consisted of routine management and oversight following the cycle of surveys, reports, and material updates.
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The MVG Clinical Project Management Consultant worked directly alongside the primary REMS Program Manager at the client. However, when that employee unexpectedly left the company, the MVG Consultant stepped up into the Program Manager role, increasing both weekly hours committed to the project and project responsibilities. This swift action allowed for a seamless transition between the client’s full time employee and MVG’s taking over management of the program. The MVG Consultant then served as the interim REMS Program Manager for over 6 months until the client was able to find a full time replacement. When a full time replacement was found, our MVG Consultant aided in their onboarding and training, providing yet another seamless transition into a new REMS Project Manager.
Just a few months after the new lead REMS Program Manager was hired, the REMS Program was inspected by the FDA. Our MVG Consultant provided pivotal support and program knowledge during the inspection, directly aiding in the highly positive inspection outcome.
Throughout the entirety of MVG’s work with this client, our Clinical Project Management Consultant has brought increased value to the project, adapted to rapidly changing circumstances, and most importantly, has aided in the successful FDA inspection of the REMS Program.
Clinical Quality Assurance
MVG has been tasked on several occasions with assisting smaller pharmaceutical/biotech companies to help set up a clinical quality assurance function as they move from the laboratory into the clinic.
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This usually involves conducting a gap analysis of their existing program, reviewing standard operating procedures in place and identifying SOPs that are applicable to the client’s current level of clinical development. This also includes setting up vendor management programs to allow the clients to properly select and manage vendors. MVG also assists in developing a quality manual, audit plans, and corrective and preventive action programs.
Medical Writing
MVG Consulting was brought in to help out with a medical writing project for a small pharmaceutical company to help with clinical study reports, investigator brochures, and and to assist with a new drug application.
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Upon discussion with the FDA, the company discovered that there were several hundred narratives that needed to be written for a number of adverse events of special interest that the agency was concerned about. MVG was able to quickly assemble a team of medical writers to assist in this additional work. The narratives were included in the new drug application which resulted in an approval of the drug for a diabetes indication.
Inspection Readiness
A client working on a rare disease indication called MVG Consulting to help them get ready for a series of regulatory agency inspections at both their vendors and at their clinical sites due to a pending marketing application to be filed.
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The client had a history of poor performance and possible GCP issues internally and at their vendors and sites. MVG was able to put together a multidisciplinary team to address issues internally at the client, at several vendors, and at the clinical sites most likely to get inspected. Mock inspections were conducted, vendors and sites were audited, corrective action plans were put into place, and the team worked with all parties to resolve most of the issues. The result of this exercise resulted in 4 successful site inspections with no findings or 483s issued. The client ultimately got approval for their rare disease indication.
Monitoring
A new client approached MVG Consulting to inquire about our site monitoring services. The client had outsourced most clinical development services to a larger CRO and were not happy with the quality of the monitoring that they were receiving at their sites.
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The CRO had assigned Junior level monitors to the sites resulting in several GCP issues that were concerning to the client. The client hired MVG to provide senior-level monitoring oversight and training of the Junior level monitors at most of their sites. The team of MVG senior-level monitors was able to help the client get back on track with their monitoring plan and improve the quality of the monitoring overall for the project.