Interactive Response Technologies

Vendor Selection and System Implementation

• Evaluate and recommend the best IRT vendor based on the Sponsor’s trial needs (e.g., Medidata Rave RTSM, Suvoda, 4G Clinical).
• Assist in system configuration to match trial protocol requirements, including randomization, drug supply management, and patient enrollment.
• Conduct User Acceptance Testing (UAT) to ensure the IRT system functions correctly before deployment.

IRT Training and Site Support

• Provide training and support for sites and investigators on how to use the IRT system effectively.
• Offer help desk support to troubleshoot issues related to patient randomization, drug allocation, or system errors.
• Monitor site performance and escalate non-compliance to the Sponsor.

Randomization and Treatment Allocation

• Design and manage randomization strategies to ensure unbiased and compliant treatment allocation.
• Ensure blinding integrity by controlling access to treatment assignments for different stakeholders (investigators, pharmacists, etc.).
• Provide real-time monitoring of randomization trends to prevent imbalances in treatment groups.

Drug Supply Chain and Inventory Management

• Use IRT to track and automate drug supply logistics, ensuring sites have the correct medication without overstocking or shortages.
• Optimize resupply algorithms, reducing drug wastage and saving costs.
• Manage drug returns and destruction, ensuring compliance with Good Manufacturing Practice (GMP) and regulatory guidelines.

Patient Enrollment and Site Management

• Automate screening and enrollment, ensuring patients meet eligibility criteria before randomization.
• Prevent over-enrollment or under-enrollment by monitoring site recruitment targets.
• Ensure protocol adherence by setting IRT rules that prevent protocol deviations (e.g., dosing limits, patient eligibility criteria).

Regulatory Compliance and Data Integrity

• Maintain audit trails of all IRT transactions for compliance with regulatory agencies (FDA, EMA, MHRA).
• Ensure IRT data aligns with Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS) for accurate reporting.
• Support risk-based monitoring (RBM) by using IRT data to flag potential protocol deviations or issues.

Real-time Reporting and Analytics

• Provide Sponsor with custom dashboards and real-time reports on:
  • Patient enrollment status
  • Drug supply levels
  • Treatment compliance trends
• Generate ad-hoc reports for decision-making and regulatory submissions.
• Assist in data reconciliation between IRT, EDC, and other trial systems.

Cost and Efficiency Optimization

• Help Sponsors reduce trial costs by optimizing drug shipments and minimizing waste.
• Improve trial efficiency by automating key trial processes, reducing manual errors and administrative burden.
• Use predictive modeling to anticipate supply needs and prevent delays in trial execution.