Groundbreaking Clinical Trial Research on Genetic Basis of Children’s Health

Inova Translational Medicine Institute, a not-for-profit research initiative bringing personalized medicine to the public, has chosen a joint solution by Medidata Solutions and Digital Infuzion to support a unique observational study involving the correlation between a child’s genetic profile, their development and their long-term health. Together, Medidata and Digital Infuzion will deliver a web-based portal and cloud technology for collecting patient data, reviewing study progress and providing subjects with access to surveys and study information.

In a unique combination of genomics and clinical research, Inova is studying 2,500 families to analyze and predict the relationship between genetics and childhood developmental issues. The study will follow the infants for the first 1,000 days, starting in utero, and identify any health and development issues. By comparing these with the genetic profile of each family (child, mother and father), Inova hopes to identify specific genomic information associated with the medical issues, ultimately leading to new treatment and prevention pathways.

•    “We needed not only a sophisticated research design, but also the appropriate technology in order to conduct this unique investigation of genetics and infant health,” said John Niederhuber, MD, Inova EVP, CEO of the Inova Translational Medicine Institute and former director of the National Cancer Institute. “The clinical technology from Medidata and Digital Infuzion, both companies with strong reputations for supporting life science research with innovation, will allow for the smooth collaboration of the research team as well as the full participation of the parents in this study.”

The joint solution will bring together Medidata Rave®—the industry-leading system for capturing, managing and reporting clinical research data—with Digital Infuzion’s N of 1™ Health Research Platform—a technology service that provides tools for physicians and other care team members to collect, monitor and report on data and medical knowledge related to observational research, chronic disease and patient outcomes. Through a computer single sign-on, researchers will enter data about subject health, monitor participants and track study progress. Participating parents will complete surveys every six months via the portal and will have access to study updates and a library of materials to guide them through the three-year trial. Researchers can also generate immediate ad hoc reports aggregating real-time data from multiple sources, including patient health data from Rave and surveys, and genomic sequencing stored in the Amazon Cloud.

•    “By combining clinical data with individual gene sequencing, Inova is truly pushing the boundaries of medical research to identify exciting new treatments and prevention pathways,” said Glen de Vries, president of Medidata Solutions. “We have continually evolved the Medidata platform and its integrations with forward-thinking partners, such as Digital Infuzion, to create the innovations that enable novel research like this.”

To support efficient study execution and insightful analysis, Inova required an intuitive system that made it easy for parents and site staff alike to enter patient observations and access study information, while also offering robust reporting that could generate dynamic, data-rich reports to enable insightful analysis.

•    “Digital Infuzion is dedicated to optimizing knowledge sharing in clinical development and improving the research experience to enhance patient health,” said Hemant Virkar, president of Digital Infuzion. “We’re truly excited to once again partner with Medidata and leverage our combined technologies in support of Inova’s visionary research.”