Clinical Trial Computerised Systems and Electronic Data – Lessons Learned Implementing the New EMA Guideline

Healthcare > Clinical Trials11/28/2023 3:00 PM

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The new framework of globally applicable standards for clinical trial data, effective from September 9, 2023. All companies now need to implement the EMA guideline on computerised systems and electronic data in clinical trials if the data will be used to support a marketing authorization in the European Union (EU). Effective on September 9, 2023, the guideline sets forth consolidated requirements on the use of computerized systems, the collection and use of electronic data and introduces a new framework of standards to be upheld by sponsors, investigators and their service providers globally. The new guideline impacts sponsors, investigators and service providers involved in running clinical trials. Join this ICON webinar to gain the knowledge required to achieve compliance with the new regulatory regime, with a strong focus on data accuracy, security and operational efficiency of the trial.


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ICON plc

ICON plc

ICON plc is a Clinical Research Organisation (CRO) that specializes in drug development. Their solutions span the entire lifecycle of product development and commercialization, and can be adapted to suit small local trials or large global programs. With expertise in various therapeutic areas, ICON works with leading investigators to manage studies in major geographies. They also provide services in clinical & scientific operations, consulting, early clinical, laboratories, language services, medical imaging, site & patient solutions, strategic solutions, and Symphony Health Technologies.