ACCeSS AI Accelerator for Clinical Study Setup

The clinical study setup process, including electronic clinical outcomes assessments (eCOA), is resource-intensive and heavily reliant on specialized skills. Challenges such as translating protocols, retrieving requirements, managing questionnaires, and generating test data are often handled manually, leading to inefficiencies and increased operational costs.

The ACCeSS AI solution, powered by Microsoft Azure services, has been specifically designed to empower Life sciences’ customers like pharmaceutical manufacturers and clinical trial management solution providers to overcome these challenges and enhance operational efficiency.

This solution leverages a robust suite of Azure technologies, including Azure OpenAI, Blob Storage, Azure AI Search, Cosmos DB, Application Gateway, App Service, and Azure CDN to enable the automation and acceleration of clinical study setup, reducing time-to-market.

Background Building each study from scratch is time-consuming, requiring significant resources and delaying delivery. Errors, protocol amendments, and the resulting rework further escalate costs and extend study timelines, while the lack of standardization across independently built studies results in inconsistent workflows and reduced efficiency. Replicating successful study designs is difficult due to manual and ad hoc configurations and scaling them across multiple studies or sites requires extensive duplication of effort. Frequent protocol amendments add to the complexity, as updating the study build to reflect changes is labor-intensive and error-prone, particularly when changes impact multiple components. Additionally, extracting relevant insights from detailed protocols is challenging, leading to delays and missed opportunities to optimize trial success. These inefficiencies directly impact data availability for sponsors, CROs, and regulatory authorities, slowing decision-making and increasing time-to-market. The manual nature of the setup also makes onboarding new team members time-consuming, as they must learn intricate processes and potential pitfalls, further straining resources.

Solution Automated document generation The solution extracts critical insights from protocols and regulatory documents with high accuracy, eliminating manual errors and accelerating document analysis. This ensures consistent generation of high-quality and compliant documentation, speeding up the setup process. Accelerate Platform Setup The solution enables faster development and testing iterations for repeatable study designs by automating generation of configuration code, metadata, mockups and validation and test scripts.

Standardization The solution promotes standardization and minimizes effort duplication by automatically matching and retrieving reusable instruments from the eCOA library.