Clinical Development

Project Rescue

You carefully qualify and choose the CRO and other vendors you will use and assume that the vendors and study team will execute the project as planned. You assume that the sites that are chosen have the clinical research expertise and the patient population for your study. The eTMF that will be used for the study will be set up properly, kept up to date with study documentation and reviewed on a regular basis. The monitoring will be performed according to the monitoring plan. The sites will enter the data into the EDC in a timely manner. There will be no turnover of staff internally or at any of your vendors.

We all know that we don’t live in a perfect world and even the most carefully planned project can hit a bump in the road. MVG Consulting Services has a proven track record of helping clients with the most challenging situations get their project back on track. MVG Consulting Services steps in when a project is in jeopardy due to mismanagement, staff turnover or inexperience, site issues, GCP issues, or monitoring issues. With a well proven model that works, MVG will provide provide a single consultant or team of consultants to address the issues and to bring the project back on track.

mvg clinical trials sop standard operating procedure development

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