“Ask AI” RACT

AI-Enhanced Risk Assessment in Clinical Trials

Smarter Workflows

Address AI-detected risks during protocol design or transfer selected risks to RACT

Targeted Mitigation

Receive AI-suggested mitigation actions for relevant risks

Self-Learning Adaptability

Libraries that adapt across studies, eliminating redundant setups and surpassing Excel’s limits

Breaking Free from Spreadsheet Limitations

Managing risks in clinical trials can be overwhelming due to complex protocols, patient diversity, and dynamic operational changes. Many teams rely on Excel-type worksheets, which are prone to errors, manual effort, and limited scalability. Without an effective process, teams face issues like trial delays, safety concerns, and data integrity risks.

  • Excel can’t compete: smarter risk management AI-guided, self-learning and GCP-compliant workflows replace manual spreadsheets for a scalable, future-ready solution

Would you like to optimize in the area of:

  • Manual Risk Tracking

    • Move beyond static spreadsheets with real-time, cloud-based automation.

  • Therapy-Specific Risk Identification

    • Address risks unique to indications like Oncology, Heart Failure, and Rare Diseases.

  • Scalable Risk Libraries

    • Tap into self-learning risk libraries that grow with your studies.

  • Integrated Mitigation Actions

    • Easily link risks to AI-enhanced mitigation steps without manual cross-referencing.

Risk Management Optimization Opportunities

Explore how the MyRBQM® RACT can support you:

  • Automated Risk Tracking

    • RACT automates data capture and risk categorization, providing a centralized, real-time platform that eliminates manual data entry and reduces errors common in static spreadsheets.

  • Therapy-Specific Risk Management

    • The MyRBQM® RACT module includes risk libraries tailored to specific therapeutic areas, ensuring that risks unique to Oncology, Heart Failure, and other indications are effectively addressed from the start.

  • Self-Learning Risk Libraries

    • RACT’s self-learning risk libraries evolve with every trial, automatically capturing lessons learned and expanding to support diverse therapeutic areas and study designs without requiring manual updates.

  • AI-Linked Risk Strategies

    • On-demand, RACT links risks to AI-suggested mitigation actions, allowing teams to easily select and implement the most effective strategies without manual cross-referencing or additional configuration.

Key Benefits for Risk Managers

Ask AI to Suggest Mitigation Actions Tailored to Your Trial’s Needs

MyRBQM® RACT – More Than Just a Spreadsheet

In 2013, TransCelerate introduced the Risk Assessment and Categorization Tool (RACT) as a simple, spreadsheet-based approach for assessing risks across clinical trials. Cyntegrity took this concept further by integrating RACT into a cloud-based platform with AI capabilities:

  • Built-in Integrated Quality Risk Management Plan – IQRMP
  • AI-augmented mitigation action suggestions directly linked to identified risks
  • Real-time study team collaboration for stakeholder alignment

Cyntegrity’s constantly evolving MyRBQM RACT module includes over 10 indication-focused libraries, covering areas such as Healthy Volunteers, Rare Diseases, Heart Failure, Oncology, Pulmonology, Diabetes, and more. These libraries address specific risks like subject safety, therapy cycles, and disease-specific outcomes.

AI-Enhanced Protocol Assessment Tool

Before entering the RACT step, the AI-Enhanced Protocol Assessment Tool analyzes protocol documents and highlights potential risks, allowing teams to optimize the protocol before the trial begins. If the protocol has already been signed off, users can manually select and transfer relevant risks to the RACT module for further mitigation.

Request a Demo and Learn More

Streamline your trial’s risk assessment today!

Discover our RBQM Solutions

  • Technology

Perfectly suited for all trial formats, including Decentralized Clinical Trials (DCTs) and Hybrid approaches, the MyRBQM Portal puts data quality, reliability, and patient safety first.

  • People

Embrace a quality-by-design (QbD) culture with education that helps study teams grasp and reap the benefits of risk-based trial management, ensuring full adoption and compliance.

  • Process

To facilitate the successful roll-out of a cross-functional RBQM system, our Functional Service Provider (FSP) model extends to the associated processes and activities.

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