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Spotlight

Digitalisation in clinical trials: what, how, why? 2 Biotech case studies

For their second joint webinar flanders.bio, BioWin & BeCRO have the pleasure to invite you to learn more about what digitalisation means for your organisation and how and why it should be integrated in your clinical development process.
Register now for this webinar on June 22nd 2021 at 11:30 am by clicking on the link https://www.eventbrite.com/e/webinar-digitalisation-in-clinical-trials-what-how-why-tickets-154356399145.

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Clinical Trials Information System (CTIS) reaches major milestone towards go-live and application of the Clinical Trial Regulation

EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022. The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary […]

Read More "Clinical Trials Information System (CTIS) reaches major milestone towards go-live and application of the Clinical Trial Regulation"

EU regulators expand use of remote source data verification in clinical trials during the COVID-19 pandemic

The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic (V4 04Feb21) expands the use and scope of remote source data verification (rSDV) in clinical trials. Now, in addition to trials involving the treatment or prevention of COVID-19, remote SDV may be considered for […]

Read More "EU regulators expand use of remote source data verification in clinical trials during the COVID-19 pandemic"

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