Digital transformation in healthcare has led to the use of computerised systems and electronic data in healthcare more widely than before. Large volumes of patient data need to be managed and analysed regularly, bringing the need for data privacy and security into play. Upgrading rules and regulations around the use of this data is important to safeguard patients who are participating in clinical trials. EMA has established a new guideline to be effective from 9 September 2023 to guide sponsors, investigators, CROs and other related parties in the use of computerised systems and electronic data gathered during clinical trials. After this effective date, any biotech or pharmaceutical company in the EU seeking marketing authorisation of medicinal products will need to implement this guideline to ensure compliance of individuals accessing or using electronic data.

This whitepaper provides you with:

• Overview of the evolution of the guideline, its scope and impact
• Requirements for establishing reliability and accuracy of computerised systems used in trials
• Non-technology related perspectives for sponsors such as processes, people, project delivery, financial, vendors and investigators
• Guidance on systems such as eCOA and ePRO which are linked to the growing use of decentralised clinical trials
• Key insights on the use of electronic data from ICON’s IT, QA, Delivery and Digital experts
• Strategic considerations for sponsors.