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ClearSite RBM

Bioclinica's ClearSite is helping 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.

What is ClearSite?

Patient Focus

Bioclinica ClearSite

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

Bioclinica ClearSite

provides sponsors the ability to oversee data quality and maintain control of trials even when outsourcing to multiple CROs.

Bioclinica ClearSite

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

Bioclinica ClearSite

is source data agnostic, API enabled and 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?

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Business Challenges

Sponsors

  • 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

CROs

  • 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's ClearSite is designed to support a quality management approach to trial execution, inclusive of risk-based monitoring. ClearSite helps you detect 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's ClearSite can support your needs and help deliver:

  • Improved operational efficiency
  • Risk mitigation
  • Regulatory compliance

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Benefits of ClearSite

ADDITIONAL RESOURCES

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

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Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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