Our mission is to provide novel IT solutions to problems in healthcare research, with an emphasis on the development of web-based systems to support novel clinical trials and observational study designs. Our EDC systems provide features to support complex data entry, with reporting and notification workflows involving core labs, event adjudication committees, sponsors and regulatory agencies.
Background and expertise:
- Web-based Data Collection Systems - The informatics group was one of the pioneers of the use of remote electronic data capture (EDC) systems for clinical trials in the 1990s. and the group has built and maintained a large number of web-based EDC systems for government and commercially sponsored clinical investigations, including the NHLBI-sponsored Cardiothoracic Surgical Trials Network (www.ctsurgerynet.org) , the FDA-sponsored PANDA study of long term effects of pediatric exposure to anesthesia and the NINDS-sponsored ARUBA trial for unruptured brain AVMs.
- Enterprise Event Reporting Systems for Patient Safety - The team developed Mount Sinai's medical event reporting system (MERS), which was sold to General Electric and is currently in use in hospitals across the country.
- Web Based Reminder and Notification Systems - We built a web-based reminder and notification system to facilitate communication between oncologists and treatment providers for breast cancer patients, which is currently being evaluated in a multi-center trial.
- EDC system Integration with Routine Clinical Encounter Data - We are developing new EDC system designs that can bring down the cost of healthcare research by integrating with other hospital systems and enabling investigators to develop their own web-based data entry systems.