The ISMMS Clinical & Translational Science Award (CTSA), ConduITS, was awarded a supplemental grant to establish a Clinical Trials Management System (CTMS) for the Mount Sinai Health System (MSHS). The CTMS is a centralized, web-based technology solution for the management of clinical trials. The chosen software is OnCORE, a product of Forte Research Systems, which has already been successfully implemented in the Tisch Cancer Center and was successfully implemented in 44 institutions throughout the country.

Why Now? 

  • The increase of the MSHS’ portfolio of clinical trials with the integration of new hospitals.
  • The need to coordinate clinical trials across multiple, remote MSHS hospitals with disparate management methods.
  • The size and complexity of clinical trials throughout MSHS.

Benefits

  • Holistic approach to organizational strategic planning based on enterprise-wide reporting & analytics.
  • Integration of trial & subject data with Epic Electronic Health Record to streamline the processes for research staff & strengthen patient safety & billing compliance.
  • Standardization of business processes to meet compliance requirements & audit readiness.
  • Real-time access to central clinical trial information at local & remote sites.
  • Establish consistency of administrative, operational & financial aspects of trials across the MSHS.
  • Increase efficiency of trial management and reduce trial-related costs.
  • Provides comprehensive tracking & reporting functionality for subjects, documents, financials and compliance.

Impact

Department level enhanced clinical trial management functions:
  • Electronic data capture & data management.
  • Protocol & subject life cycle management.
  • Subject visit tracking.
  • Research billing compliance, budgeting & invoicing.
  • Effort tracking.
  • Task management.
  • Reporting.
  • Security – HITECH compliant & customizable security & access roles.

Phased roll-out of OnCORE by department

Department participation will require:
  • Analysis of current workflow.
  • Gap analysis.
  • Identification of super-user for implementation and training.

Return on Investment

  • Increased functionality, efficiency and compliance.
  • Reduction of redundant and duplicative steps.
  • Central access to study data & comprehensive overview throughout conduct of study.
  • Standardization across multiple sites & the health-systems.
  • Enhanced clinician/researcher awareness of study activities.

ConduITS and Research IT are working together to implement this enterprise-wide enhancement for the clinical research community. Periodic updates, communications and timelines via the research listserv will be shared to assist in your planning for this transition to a centralized electronic clinical trials management system.

If you have any questions please contact us via: ORS Research 411 Portal