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    Risk-Based and Centralized Monitoring

Improve Quality, Minimize Cost

Enable successful risk-based monitoring through our simple, smart, flexible solutions.

OmniComm leads the industry in providing advanced solutions for risk-based monitoring (RBM) through:

  1. An integrated EDC (TrialMaster) and analytics solution (Acuity) that enables risk-based monitoring and ICH E6 (R2) compliance.
  2. A platform-agnostic solution that integrates data from multiple systems, thereby allowing study teams to monitor key risks from different operational and scientific aspects. We think of risk monitoring beyond data from EDC systems.
How does Acuity Analytics platform achieve this?
  • Risk Plan: Assists with holistic risk planning, mitigation and cross-functional collaboration, which can be customized to study and organizational needs.
  • Central Monitoring: Risks that need to be monitored can be objectively deciphered and measured using key risk indicators (KRIs) and critical data points. Central data monitoring is enabled through our data visualizations that can be readily leveraged from a standard library. We also provide the flexibility to create data visualizations and custom logic for effective monitoring to suit your needs.
  • Decision Factory: When complemented with data review through Acuity data visualizations, the Decision Factory provides insights into how sites perform on KRIs through an aggregate site risk score. Hence, two impressions emerge – a macro-level site risk assessment to understand which sites have a higher risk propensity and a granular level of specific insights into which subjects or operational aspects are contributing to the risk.
  • TrialMaster Targeted SDV: As the outputs of central monitoring through data visualizations review and site risk assessments are generated, this information can be used to rationally perform targeted and focused source data verification (SDV) at the site on pertinent subject data using the T-SDV module in TrialMaster.
  • Action Center: The issues that emanate from central monitoring and/or targeted SDV can be captured through the Action Center, which enables issues to be managed and resolved productively in a single place without using multiple systems such as email, trackers, etc. Essentially, Action Center is a closed loop issue management tool.

RBM Enablement Consulting  - Guided by deep clinical R&D and RBM expertise, we will enable your organization to build or fill the process gaps and enable technology implementation during early stages of adoption.

Click here for more information on Acuity Analytics and Risk-based Monitoring.

Contact Us      North America +1 877.468.6332      Europe +49 (0) 228 227 440      Click Here to Email Us

Contact Us
North America
+1 877.468.6332
Europe
+49 (0) 228 227 440
Click Here to Email Us