The integration of computerised systems and electronic data standards continues to play a vital role in the conduct and management of clinical trials as well as in ensuring the clinical trial data reliability and the protection of patient safety and rights from systems and electronic data perspective. The EMA released its guideline on Computerised Systems and Electronic Data in Clinical Trials in September 2023. All biotech or pharmaceutical companies worldwide seeking marketing authorisation of medicinal products in EU are subject to this guideline. As the implementation deadline has come and gone, we explore the ongoing challenges of navigating the boundaries of scope related to compliant implementation – from the high resource investment required to develop and adapt systems across multiple stakeholders to understanding the regulatory layers around impacted data systems.

Bracing for Broad Impacts on Clinical Research
The EMA’s new guideline introduced a future-focused framework for ensuring the integrity, security and traceability of electronic data. Among its key provisions, it reinforces the importance of access controls, user authentication and data encryption to safeguard against unauthorised access and breaches. Additionally, it places greater emphasis on audit trails, ensuring transparency and traceability in data modifications and reinforcing the reliability and authenticity of electronic data in clinical trials.

One of the most significant shifts the guideline introduced is expanding the scope beyond clinical data. Under the new framework, “any trial related data handled in electronic systems for the purposes of conducting and reporting a clinical trial, and relevant for the clinical trial”, as clarified by EMA, is now within its remit. This change has prompted sponsors, sites, CROs and vendors to reevaluate their computerised systems and electronic data management, ensuring that all relevant systems and system owners align with the new requirements. As organisations reorient around this shift, a critical challenge remains identifying and mitigating potential gaps that now fall under regulatory scrutiny.