Risk Based Monitoring Services

In order to drive cost efficiencies, reduce clinical trial complexity, and ensure regulatory compliance, pharmaceutical companies are adopting a risk based monitoring (RBM) approach. However, shifting to the RBM model brings in challenges such as hiring staff with the right expertise, ensuring data integrity, defining key risk indicators (KRIs), and investing in change management.

TCS’ RBM Services leverage industry standard tools and methodologies and centralizes risk functions for holistic assessment of clinical trials to ensure patient safety and data integrity.

The TCS Advantage

TCS partners with pharmaceutical companies to create a risk based monitoring strategy that aligns with TransCelerate’s model for effective risk management. We also offer the following unique advantages:

ValueBPS: Our ValueBPS approach helps enterprises achieve significant and sustained business outcomes by leveraging our deep domain expertise and operations redesign methodologies such as FORE. Our approach also encompasses robotic process automation (RPA), analytics and insights, our unique IT-BPS synergy, Business Process as a Service (BPaaS) models, and business process management (BPM).

Industry domain expertise: TCS has extensive expertise in RBM methodologies, global clinical project management, and in setting up and running centralized monitoring operations.

Analytics and insights: Our integrated data warehouse supports predictive analytics across data sources. Clients can develop customized TIBCO Spotfire reports to assess critical trends in patient enrollment, safety, and site performance.

BPaaS/Platforms: We offer a single application to view and respond to monitoring results. It also supports role definition for users and offers the ability to view and interact with study dashboards developed in TIBCO Spotfire from within the user interface of the centralized data monitoring system.

Solutions We Offer

TCS Risk Based Monitoring services include:

  • Identification and monitoring of critical processes across clinical trial phases using TCS’ KRI repository along with study-specific KRIs
  • Generation of study risk scores and a dynamic Targeted Source Data Verification (TSDV) strategy by mapping KRIs to the Risk Assessment Categorization Tool
  • Site feasibility assessment for clinical trials using the site risk scoring tool, which can be customized to study requirements
  • Access to real-time reports and dashboards based on clinical operations inputs, using a centralized data monitoring portal

Benefits

TCS Risk Based Monitoring Services enable pharmaceutical companies to reduce drug development cycle time and clinical trial costs, obtain faster regulatory approvals, and improve the ROI on risk management. In addition, it offers the following benefits:

  • Over 30% savings in clinical trial costs
  • Increased patient safety through high-quality data
  • Improved clinical trial efficiency driven by risk assessors with accurate data
  • Reduced exposure to risks

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