A US-based clinical trials organization (CRO), known for its commitment to advancing medical research, faced significant challenges in managing and validating their suite of customized software tools and applications used at clinical trial sites. The complexity of automating studies, coupled with the need for code changes for each new study, resulted in inefficiencies and increased manual effort, hindering their ability to maintain high standards of accuracy and efficiency in clinical trials.

• Complex Validation Processes: The company’s computer system validation (CSV) services required extensive support in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing. Automating a study was not straightforward, as each new study demanded specific code changes, making the process cumbersome and time-consuming.
• Legacy System Maintenance: Maintaining and validating legacy software suites while integrating new tools posed significant challenges. The legacy systems required continuous updates and validations, which added to the complexity.
• Manual Effort and Inefficiency: The need for manual effort in test execution and validation processes was high, leading to inefficiencies and increased potential for human error. This manual approach was not sustainable in the long run, especially with the growing number of studies and sites.

Airo provided a comprehensive AI Data Engineering solution to address these challenges. Our approach included:

• Framework Design: Created a single, unified framework that integrated various tools to support UI, API, and mobile automation. This framework was designed to be adaptable, allowing for seamless integration of new tools and technologies as needed.
• Automated Scripting: Provided KEYWORD designer support for automated scripting, which allowed for the configuration of reusable test scripts based on new site requirements. This approach ensured that each new study could be automated more efficiently, without the need for extensive code changes.
• Legacy System Assessment and Maintenance: Conducted thorough RPA assessments and proof of concepts (POCs) for test automation in legacy software suites. This included evaluating the current systems and identifying areas where automation could be most effectively implemented.
• New Product Integration: Assessed and implemented new products to replace legacy systems where appropriate. This involved evaluating new technologies and tools that could enhance the validation process and streamline operations.
• Custom Questionnaire Automation: Automated the customized questionnaire screens using LF objects. This allowed for consistent and accurate data collection across different sites and studies, reducing the risk of errors and improving the reliability of the data collected.

The implementation of Airo’s AI Data Engineering solutions led to significant improvements for the clinical trial organization:

• 30% Increase in Test Execution Cycle: The streamlined processes resulted in a 30% increase in the test execution cycle, enhancing overall efficiency. This allowed the organization to conduct more studies in a shorter period, accelerating the pace of their research.
• 40% Reduction in Manual Effort: Automation significantly reduced the need for manual effort, leading to a 40% reduction. This freed up valuable resources and allowed the team to focus on more strategic tasks, improving overall productivity.
• Over 80% Automation Achieved: The high level of automation achieved (>80%) resulted in more reliable and consistent validation processes. This not only improved the accuracy of the data collected but also ensured compliance with regulatory standards.

Partnering with Airo enabled the clinical trial organization (CRO) to transform its validation and testing processes. The comprehensive AI Data Engineering solutions provided streamlined operations, reduced manual effort, and enhanced efficiency, allowing the company to focus on its core mission of advancing clinical trials. By automating complex validation tasks and integrating new technologies, Airo helped the organization maintain its competitive edge in the life sciences industry.

Our collaboration exemplifies how strategic AI data engineering and automation can drive success and innovation in the life sciences industry. The clinical trial organization is now better equipped to handle the growing demands of medical research, ensuring that they can continue to deliver high-quality, reliable results that contribute to the advancement of healthcare.