EMA's Updated Guidelines: Key Changes For Computerized Systems & Electronic Data In Clinical Trials

To stay aligned with technological advancements and industry best practices, the European Medicines Agency (EMA) regularly updates its guidelines, ensuring their relevance and currency. In a recent regulation modification, the EMA released new guidance regarding computerized systems and electronic data in clinical trials as compared to the reflection paper on electronic data collection tools in clinical trials this guideline replaces.

The new guideline sheds light on the evolving landscape of electronic data management in clinical trials, aligning with themes seen in other regulations put forth by the EMA, such as EudraLex Annex 11. Stay up-to-date with these latest developments by accessing the full article below.