Clinical Research

For over a decade, MDC’s Clinical Research group has facilitated immunization programs through education, training, and research. Our experts provide highly qualified medical, lab, and research support services across multiple functional areas including:

• Protocol development
• Subject enrollment
• Data cleansing
• Management abstraction and validation
• Statistical analyses
• Biospecimen processing, storage and shipment
• Generation of publications and presentations

MDC Clinical Research support includes:

• Clinical Investigations: MDC supports all clinical investigation projects and provides laboratory support. As each study has its own processes and protocols on how and when the data is collected and documented, this group is responsible for developing and managing various clinical registries by creating data forms to collect clinical data over time on subjects.
• Outcomes: Starting in 2018, MDC has developed reports and research protocols to further information discovery on diseases like Myopericarditis and Pericarditis caused by Smallpox or COVID-19 vaccinations. The compilation of all the supported applications by MDC provide a synergistic platform that allows the user community to access and analyze information, create, and manage cases, enroll those patients into research protocols, and report on the results. MDC assists in the development of algorithms which provide evidenced based data from information stores to rate and score forms providing the organization answers to clinical questions and identify statistical trends or anomalies in their research protocols and requested reports. MDC provides clinical support through use of point-of-care applications.
• Healthcare Informatics: MDC currently supports the operation and maintenance, infrastructure hosting and coordination of health information systems. This support is focused on open-source .NET platform applications with a Microsoft SQL Server database backend. MDC has developed, maintained, and enhanced these applications continuously over the last three years.

MDC Clinical Research Group in Action

In support of clinical investigations across the military and beneficiary populations, the MDC Clinical Research Group addresses the safety, acceptability and effectiveness of immunization programs. Case studies include:

• Immunization Healthcare Clinical Studies: MDC developed a web-based application that supported role-based access as well as addressed security requirements of the government. The new process allowed for real-time documentation of adverse event data, through the ability to create a Vaccine Adverse Event Reporting System (VAERS) automatically from within the application and interface with the DoD Defense Enrollment Eligibility Reporting System (DEERS) to import patient vaccination data.
• CDC: In 2014, MDC assisted in the development of a scanning interface to receive all military VAERS forms that are received by the CDC VAERS. Importing these VAERS reports into the Vaccine Adverse Event Clinical System (VAEC) allows analysts to review all military adverse events. The interface allows the organization to contact patients and track a much larger population of adverse event cases within VAECS.

This adverse event review was recently updated in 2020 to allow for the identification of individual vaccines to facilitate COVID-19 vaccine research and reporting. This has generated additional VAECS reports that have facilitated the COVID-19 vaccine response by providing statistical information to commands and identifying trends.