When the stakes involve patient outcomes and the credibility of clinical trials in the medical, health and pharmaceutical sectors, maintaining data accuracy, integrity and privacy is essential.
In 1997, the US Food and Drug Administration (FDA) initiated a series of regulations to provide guidance on how to ensure the trustworthiness of electronic records and data. Over the ensuing decade, these guidelines were revised and formalized as the FDA Code of Federal Regulations Title 21 (FDA 21 CFR Part 11).
Anthony Chamberas, who recently led an FDA 21 CFR Part 11 certification process at Steritas commented, “The regulations make sure that an organization has embedded policies and practices that ensure security and compliance, as well as data and algorithmic integrity.”
He further elaborates, “From a software standpoint, three types of tests need to be performed: operational, performance and installation.
Operational tests ensure the software operates the way it is intended to and performance tests ensure accurate responses to queries are output. Finally, installation tests ensure the software can be installed and used in the systems it is intended for.”
Developing and recording test plans, and subsequently consolidating the results into a report, is critical. If any test fails, the report needs to delineate the prospective remedial measures. Given that these tests are mandated after each update, automating them, despite their initial labor-intensive nature, can expedite an organization's ability to roll out updates swiftly – a crucial aspect in the agile software development landscape.
"The adoption of agile development methodology and automated testing frameworks enables us to continually refine the platform and rapidly deploy updates, bypassing the necessity for manual testing with each minor modification. Naturally, the addition of new features requires the incorporation of new tests in both the plan and the report,” added Chamberas.
“In this instance, we weren't just automating tests to iterate quickly but to also ensure consistent quality. Steritas has rebuilt the entire platform from the ground up to better support investigators in the pharmaceutical and biotech industries, academic clinicians, as well as health economics and outcomes researchers (HEORs) and health systems that investigate claims databases.”
The new platform provides access to the entire Steritas eCOA suite, which includes the GTI, pGTI and GTI-MD, and is the only way for licensees to be assured of validated results. It provides a wide range of connectivity options including a web application for bulk data uploading as well as manual data entry on individual patients. In addition, APIs and Software Development Kits or “libraries” provide both cloud and on-premise hosting options.
The completely rebuilt digital platform delivers significant speed by returning calculated toxicity scores for 100 patient records in less than a second.
Most importantly, all eCOAs have been fully tested for compliance with FDA 21 CFR Part 11 to ensure the safety and integrity of data matches the scientific standards of the instruments in the suite. Steritas made this substantial investment to support the speed and accuracy that are essential to research into new treatment regimens, health economic and outcomes research (HEOR), and decisions about individual patients at the point of care.