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Achieving a centralized view of investigative site trends and comparative performance is critical to optimizing efficiencies and data quality in today’s complex clinical research landscape. ERT’s Centralized Data Surveillance solutions are designed to support Risk-Based Monitoring (RBM) strategies by providing instant visibility into potential risks related to data quality, subject safety, and trial integrity. With instant visibility into all study data from eCOA, lab, EDC and other sources, study teams can identify, mitigate, and rectify issues as they are identified, before they become costly trends.

With the ability to centralize data in near real-time and apply clinical and operational business analytics, Centralized Data Surveillance helps research organizations optimize trial oversight with real-time insight into operational risk & performance criteria, and protocol-specific outcomes data.

Standard Surveillance categories include:

  • Operational – Study and Site Performance Metrics, Helpdesk Trends,
  • Quality – Data Integrity, Site/Patient Misconduct and Compliance Monitoring, Rater Analysis
  • Clinical – Endpoint Correlation and Trending, Predictive Analysis, Patient Safety, Outlier Analysis
  • Financial – Scope Management, Financial Transparency (Sunshine Act, EFPIA)
  • Industry Benchmarking – MCC Metrics
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Information is only valuable if it can be acted upon. To be “actionable,” information must be accessible, timely, and presented in a “decision-ready” format. .

Surveillance Process

ERT’s Centralized Data Surveillance is a data-driven solution designed to enable risk-based monitoring workflows across ERT’s Cardiac, Respiratory, and eCOA solutions. Centralized Data Surveillance leverages real-time business analytics based on relevant historical performance indicators to proactively identify and manage risk and performance trends.  Based on defined surveillance requirements, data is integrated from various sources, translated into a common language and then visualized so that study teams and ERT Project Managers can take the appropriate level of action.

Surveillance Services

With ERT’s unmatched industry experience in centralized endpoint data collection, our data surveillance teams include highly trained experts who are available to help analyze and act on the signals produced by surveillance analytics. Real-time alerts signal ERT specialists and study team members to review outliers and trends to get a detailed understanding of the root cause of the issue. The results of the findings are then used to drive a collaborative corrective action process between the sponsor and the ERT project team, using a fully documented process.

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Identifying risk is important; acting on it is critical for success.