Introduction
The Global Clinical Intelligence team of a leading pharmaceutical company aimed to develop a web-based software platform that could efficiently measure the operational complexity of clinical trials. This complexity assessment is crucial for accurately comparing performance metrics between different studies and sites, as more complex trials typically encounter greater challenges regarding time, cost, and quality.
Operational complexity in clinical trials involves factors like study design, patient diversity, site management, and regulatory requirements. Measuring this complexity aids pharmaceutical companies with strategic planning, timely resource allocation, risk management, and effective communication, ensuring trials are completed on target time. This holistic understanding ultimately leads to more efficient and successful clinical trials.
Solution Overview
We developed a solution that assesses the operational complexity of clinical trials by evaluating factors like patient, site and study. This allows the client team to make informed decisions regarding the time, cost, and quality aspects of each clinical trial study.
Our Clinical Trial Scoring Solution for the global pharmaceutical company allows users to easily upload study documents, input basic information such as phase and scoring measures, and initiate the report preparation process to help assess the complexity and operational feasibility of the clinical trial.
Key Features and Benefits
Automated Complexity Scoring :Users input basic details such as the study phase and specific measure. The system calculates complexity scores for patients, sites, and studies. Aggregated scores provide a comprehensive view of the trial's operational complexity.
Feedback Mechanism :Users can adjust system-selected sub-measures and recalculate scores. Ensures accuracy and relevance in scoring.
Report Generation and Analytics: Automatically generates graphs, reports, and aggregated analytics that include scores, values, relevant images, instances, and justifications. Reports can be viewed and downloaded for stakeholder discussions.
Data Storage and Retrieval: All data is stored securely in the database and accessible within the application. Users can retrieve old records with a few clicks.
Collaboration and Centralized Access: SMEs can collaborate within the platform, eliminating the need to share reports via email. Acts as a single source of truth for all study documents and results.
Document Library Integration: Users can score studies directly from the application’s document library if they don't have local copies.
Our Approach
The project was executed in phases to ensure smooth integration with the company's existing operations
- Requirement Analysis: Collaborated with the company's team to understand their specific needs and challenges.
- Solution Design: Created a tailored solution using a combination of AI and machine learning tools.
- Development and Testing: Developed and tested the solution iteratively to meet all requirements.
- Deployment and Training: Deployed the solution and provided comprehensive training to the company's staff.
Outcomes
The IDP solution led to significant improvements in the company's clinical trial processes:
- Increased Efficiency: Reduced document processing time by 50%, allowing faster decision-making and accelerated trial timelines.
- Enhanced Accuracy: Achieved over 95% accuracy in data extraction and document classification, minimizing errors.
- Regulatory Compliance: Ensured all documents were processed in compliance with industry standards, reducing the risk of regulatory issues.
- Data-Driven Insights: Provided valuable insights through advanced data analytics, helping to identify patterns and optimize trial processes.
Conclusion
The Clinical Trial Scoring Solution developed for the Global Pharmaceutical Company provides an advanced, automated method for assessing the operational complexity of clinical trials. By leveraging AI and cloud technologies, the customized solution offers precise, flexible, and efficient scoring and reporting mechanisms. This enables the Global Clinical Intelligence team to make informed decisions, ensuring better management of time, cost, and quality aspects in their clinical trials.
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