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eTMF

Electronic trial master file

Essential Document Collection Made Easy

We make sure that all electronic trial master files (eTMFs) are DIA TMF formatted and accessible to you and trial monitors through a secure portal that’s managed by our experienced eTMF personnel. Quality, completeness, and timing metrics are built into the system for inspection-ready files.

DIA Reference Model

We update our system structure with the latest DIA Reference Model recommendations annually.

eTMF Plan

We give each study its own eTMF plan outlining required documents and processes.

Access

Access for your team members, inspectors, and monitors can be defined and selected for the appropriate level of security.

Sponsor Oversight

We make sure metrics outlining the quality of documents, timing of submissions, and file completeness are dashboard standards in your eTMF.

Management

Documents are collected and filed by experienced eTMF personnel, trained in the DIA model and GCP regulations.

Innovations

ClinQuick®

Innovations

Celexus®

Innovations

ECG Core Lab

Innovations

E-Lab Notebook

Innovations

EDC - Electronic Data Capture

Contact

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Related to "eTMF"

News & Events

Celebrating a Decade of Biosimilars Development

06.30.20

Celerion Recognized as 2020 CRO Leadership Champion for Reliability and Receives CRO Leadership Award for Capabilities, Compatibility, Expertise, and Quality

06.19.20

Open for Business: Early Phase Clinical Drug Development during the COVID-19 Pandemic

06.18.20

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Resources

Development of an Antibody Dependent Enhancement(ADE) Assay to Support SARS-CoV2 Vaccine Development

Video

Developing an Ultrasensitive Simoa Immunoassay for IL-1β as a Biomarker for NASH

Video

Nuventra Recording: Drug Development During COVID-19 Panel Discussion – Fred Pritchard

Covid-19

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