Agile software development requires an agile approach for computer system validation of clinical trials software products

Personalized medicine seems to be a potential solution to the known challenges facing clinical research and drug development. However, the personalized approach requires many new software tools that are able to interact with each other. These applications are often developed by academic groups as part of a research project. To be employed in clinical trials, these tools must undergo a process called computer system validation (CSV) for compliance with Good Clinical Practice (GCP), regulatory and ethical requirements. Four academic developer groups of the EU project p-medicine (www.p-medicine.eu) were interviewed to evaluate the readiness of their developed products to be used for clinical research in a regulated environment. An analysis of the survey results showed that considerable gaps exist in tool maintenance, quality management and compliance documentation. Because all developer groups use agile development methods, recommendations for agile quality assurance usable in academic groups and a concept of “compliance by design” were developed to enhance quality management, prepare tool development for computer system validation and usage in clinical trials.