Clinical Development Module

The QuantHealth Clinical Development Module is an AI-powered platform designed to help leading pharmaceutical companies design, optimize, and de-risk their clinical trials. By enabling trial design teams to virtually test thousands of clinical hypotheses in minutes, the platform accelerates drug development and supports more informed, strategic decision-making across the full spectrum of clinical development activities.

The platform is highly adaptable, allowing granular modifications to virtually any protocol parameter — including inclusion/exclusion criteria, treatment and control arms, comparators, outcomes, endpoints, and analysis methods — while simultaneously assessing the clinical, operational, and commercial impact of each change.

Protocol Design and Optimization

• Modify any protocol parameter and instantly assess its clinical, operational, and commercial impact.
• Optimize inclusion/exclusion criteria to maximize clinical effect size without compromising feasibility or commercial viability.
• Evaluate different drug combinations to maximize efficacy while minimizing safety concerns.
• Test thousands of clinical hypotheses in minutes, dramatically reducing the time required for trial design iteration.

Indication Selection

• AI-based module that predicts the efficacy and safety of drugs across a wide range of medical conditions.
• Draws on variability within and across diseases to provide comprehensive coverage.
• Presents results in an intuitive and clinically relevant manner to support precise and efficient decision-making in early clinical development.

Target Product Profile (TPP)

• AI-based module that predicts key TPP parameters, with a focus on primary endpoints and safety.
• Enhances strategic decision-making by providing a reliable perspective on the therapeutic potential and safety profile of an asset.

Probability of Technical Success (PTS)

• Integrates rigorous efficacy and safety simulation with real-world evidence.
• Aids in optimizing clinical trial investments and minimizing risk.
• Enhances decision-making processes throughout drug development.

Market Forecasting

• Predicts the expected number of patients across various geographical markets based on a specific cohort definition.
• Enables comparison of global patient populations across different cohorts.
• Supports more informed and strategic commercial planning.

Enrollment Prediction

• Predicts site-level and global trial enrollment over time by analyzing the patient cohort and hundreds of protocol parameters.
• Parameters assessed include protocol complexity, site burden, estimated site performance, and investigator characteristics.
• Supports site selection and feasibility analysis, providing an essential operational perspective for trial design teams.

Prospective Validation

• The platform has demonstrated the ability to predict trial results before readout, without sponsor data, with 85% accuracy on the primary endpoint.
• Validated against multiple real-world clinical trials, including IMVOKE010 (a randomized Phase III study of atezolizumab as adjuvant monotherapy in squamous cell carcinoma of the head and neck), TROPION-Breast01, and ELOQUENT1.

QuantHealth's Clinical Development Module is built for pharmaceutical organizations seeking to reduce trial failure risk and improve the efficiency of their clinical programs through AI-driven simulation and real-world evidence integration.