MGD Services excels in providing expert project teams for clinical trials. We assist your team in delivering consistent, quality results to help move your drug through the development process quickly and efficiently.
MGD Services has years of experience in the Clinical Trials arena. We assisted in the development of a Protocol/Site monitoring system. We worked with the user community to write the business requirements on which the system was based. The system was used by CRA’s to track all of the documents required for the Protocol, Physician, Patient, and site for a clinical trial and for monitoring the site visits. Through this project and others we have developed relationships with CRO’s, CRA’s and site monitors.
We assisted in developing a clinical documentation system that scanned and indexed into Documentum the Case Report Forms and supporting documents that are used in Clinical Trial submissions to the FDA. We provided a complete quality assurance staff for assurance of 21 CFR Part 11 compliance for this project.
We also assisted in developing an Adverse Events reporting system for monitoring and tracking reactions to drugs that are in production. We provided FDA Validation auditing and a complete quality assurance staff for this project.
Additionally, MGD Services, as a GSA Awards Supplier, completed a document and records management project for the CDC in Atlanta Georgia. This project required a complete understanding of the records retention schedule required to support our government clients needs. Documentum document management system was the tool chosen to support this project.