Key considerations on the impact of the new framework of globally applicable standards
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.
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