Tag Archives: document management

Webinar on Growing need of Clinical Data, PMCF & Registries for Devices

  Post Market Clinical Follow Up (PMCF) studies are a critical component of the clinical evidence required to comply with the new European regulations. As Clinical Evidence Reports (CERs) encounter more and more scrutiny by Notified Bodies (NBs), the gaps … Continue reading

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Webinar on eTMF – Challenges, Opportunities & Trends

Essential Documents are the evidence that demonstrate Investigators, Sponsors, and Monitors have met the expectations of Good Clinical Practices (GCPs) and related regulations. The documentation stored in the Trial Master File is becoming increasingly digitized driving eTMF adoption across the … Continue reading

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