Project Overview

Investigators and research staff face many challenges in conducting research. Limited resources, ever-changing regulatory requirements and the sheer volume of research conducted at Yale create barriers that stand in the way of accurate and efficient research. Implementing an integrated, enterprise-wide system for managing research provides benefits that affect many aspects of clinical and translational research:

  • Enterprise Reporting – Research leadership can easily get reports related to study and patient volumes and other metrics to help manage the clinical research portfolio.
  • Patient safety – OnCore's Serious Adverse Events (SAE) and Data Safety Monitoring Committee (DSMC) management functionalities help improve reporting and communication among study teams, which helps improve patient safety.  Reports from the DSMC console have been used to facilitate reporting to regulatory bodies, such as the FDA.
  • Systems Integration – With Epic this includes the ability to capture patient demographics, facilitation of billing compliance, and explorations of more advanced integration designed to provide automation and increased efficiency for recruiting/referral. OnCore also interfaces with the Business Management System (BMS) to help with sponsor invoicing.
  • Study Performance – Out of the box reports include the "Low Accrual" and "Protocol Life Cycle Reports" help PIs and coordinators monitor the performance of their studies.
  • Subject Management – Research staff can identify subject milestones and track and forecast patient visits with enhanced subject calendar and electronic data capture functionalities. Web based data management and security controls will allow investigators to run large, multi-center trials.
  • Regulatory Compliance – Enhanced reporting to track compliance, regulatory documents, and subjects (ad hoc search functionalities and canned reports) can be easily accomplished. Integration with ClinicalTrials.gov will facilitate study registration and results reporting.
  • Financial Management – Defined workflow, budget and cash management tools can help improve overall financial performance and facilitate clinical trial billing compliance.
  • Unified Registries Management – Allows ad-hoc development of patient registries which can be de-identified to allow for data sharing and analysis.
  • Bio-Specimen Management – Allows for data capture of collection, processing, storage and shipment information.