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Risk-Based Monitoring

Bioclinica helps companies achieve ICH E6 compliance as well as the promise of risk-based monitoring through a modern, cloud-based solution. Our unique clinical trial quality management software allows you to deploy a risk-based, quality-management approach across studies, which easily leverages existing trial data, systems, and processes to predict and correct risk throughout the trial lifecycle – delivering improved patient safety and data quality.

How Does Bioclinica Empower Risk-Based Monitoring?

Patient Focus

Built for the Job

Start with a comprehensive, clinical trial quality management software application purpose-built for designing, deploying, and managing Risk-Based Monitoring (RBM) trials.

Maintain Control

Bioclinica Risk-Based Monitoring helps you oversee data quality and maintain control of trials even when outsourcing to multiple CROs.

See your Data, and use it!

Leverage advanced visualizations, analytics, and machine learning for robust, holistic risk prediction, detection, analysis, and management. Our technology is designed to fit into existing R&D ecosystems with no new software/hardware requirements.

Works with Multiple Data Sources

With a source data agnostic, API enabled solution you can seamlessly exchange data for use as a companion product. Integration is underway with all Bioclinica products.

Leverage Bioclinica's Expertise

What effect does ICH E6 R2 have on risk-based monitoring and overall clinical trial quality risk management?


Business Challenges


  • Reactive, non-risk-based approach
  • Manually driven processes using disconnected systems
  • Demonstrate quality oversight was achieved
  • Standardized approach to vendor oversight
  • Understanding quality in a multi-vendor model
  • Ensuring control over outsourced activities
  • Reactive vs. proactive
  • Data-driven decision making
  • ICH E6 R2
  • Inspection readiness


  • Market differentiation via technology
  • Pricing and margin pressures
  • Regulatory compliance
  • Site quality
  • Lack of transparency

  • Reactive vs. proactive
  • Data-driven decision making
  • ICH E6 R2
  • Inspection readiness

Traditional Attempts to Address Challenges

Excel Spreadsheets

Multiple Tools / Applications

In-House Built Systems

Pushing the Burden to CRAs

Outsourcing to CROs

Benefits of ClearSite

Bioclinica helps you take a quality management approach to trial execution, inclusive of risk-based monitoring. We help you detect and track identified risks using Key Risk Indicators (KRIs), as well as risks you may not be aware of through advanced machine learning and predictive analytic capabilities. Whether you are transitioning to a risk-based approach or are experienced with risk-based monitoring, Bioclinica can support your needs and help deliver:

  • Improved operational efficiency
  • Risk mitigation
  • Regulatory compliance


Benefits of ClearSite


RBM Professional Services Offerings

Download Overview Sheet

What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?

Download White Paper

Running Better Trials Taking an Intelligent Monitoring Approach

Download White Paper

Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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