CROScheck™

CROScheck clinical analytics platform

Meet ICH E6(R2) Guidelines, Enable Risk-Based Monitoring,
Increase Your Oversight, Minimize Your Workload

CROScheck clinical analytics platform

The Business Need

  1. To follow ICH guidelines and meet regulatory requirements related to taking a risk-based approach
  2. To increase safety for patients, increase trial quality, spot potential misconduct, and optimize spend through more efficient monitoring
  3. To conduct independent verification of the quality and integrity of the data collected from sites

The CROScheckTM Solution

CROScheckTM combines leading statistical methodology with an easy-to-follow E6(R2) compliant workflow. It leverages information from Statisticians and Data Managers for the benefit of CRAs by identifying the key risk indicators, pinpointing where to focus monitoring effort, and providing a mechanism to track corrective actions. It offers Sponsors of clinical trials an independent oversight of data coming from sites. It enables:

  • Risk identification and review (web based RACT and IQRMP)
  • Data visualization of all data sources including site and patient profiles
  • Cross-study analytics
  • A statistical approach for Sponsors to meet the new requirements of ICH E6(R2)
  • Targeted monitoring and SDV
  • Alerts and tracking of corrective actions for CRAs
  • A more automated approach to determine and report on key risk indicators

The Key Components of CROScheckTM

Centralized Statistical Intelligence (CSI)

Deliverables

CSI gives sponsors oversight of the quality of data coming from sites. Its technology uses Principal Component Analysis, assigns a risk score per site, and highlights erroneous data and potential misconduct.

Risk Management Metrics

data management risk management metrics

Data Managers use a suite of threshold reports in conjunction with EDC technology platforms to produce real-time reports on potentially problematical data.

Data Visualization & Analytics

clinical data visualization

An advanced data analytics platform that includes:

Risk identification tools

Workflow functionality for CRAs and data managers to identify and resolve data issues

Comprehensive profiles of both sites and subjects

Immediate visibility across multiple sources of data such as EDC, CTMS, IXRS and eCOA

Visualization of datasets regardless of software application (technology agnostic)

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