Young biopharmaceutical companies go through a logical progression headed to clinical trials of the compounds that they have nurtured through discovery and research. Quality Systems in companies in their infancy are generally based on the principals of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Companies with GLP/GMP-based Quality Systems often are challenged by the possibility of clinical trials and how they will now adapt their systems to a Good Clinical Practice (GCP) environment.
MVG Consulting Services is often asked to come into a company and assess what is needed to support clinical trials. One of the first things that is suggested is to conduct a Gap Assessment of their current system to see where they stand and how it may be adapted to a GCP environment. Most companies in early phase development are using an outsourcing model until their programs are more mature and can support the head count of providing more in-house services. A Gap Assessment will be conducted looking at their Standard Operating Procedures (SOPs) to determine which SOPs are necessary at their stage of development. MVG consultants will look at how the client qualifies and manages their vendors and if they are providing an appropriate level of oversight. Additionally, MVG will look at other parts of their Quality System including training and how they are training their employees and contractors on SOPs and regulations.
After the assessment is complete, MVG will provide a detailed report showing the deficiencies and coming up with a plan for bringing the company into compliance with appropriate SOPs to be put into place to support their clinical trials.
Contact MVG Consulting Services for more information on how MVG can assist your company as it moves from the lab into the clinic.
MVG Consulting Services specializes in helping small to medium sized biotechnology and pharmaceutical companies with their clinical development programs and we can provide start-up and virtual companies with the necessary resources to begin their clinical development program.
Services include:
- Clinical Research Consulting Services
- Clinical Trial Development
- Project Rescue
- Inspection Readiness
MVG provides highly qualified clinical research professionals who seamlessly become a part of your project team. Additionally, we provide virtual companies with an entire project team that encompasses all aspects of clinical development.
We invite you to fill out the form below to learn more about how MVG Consulting can help you with your clinical devleopment needs.
