Participate in a Study

Participate in a Study

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

Webinar: COPD – Tackling the Unmet Needs

06.04.2019 - 06.04.2019

2019 DIA

06.23.2019 - 06.27.2019

New England Drug Metabolism Discussion Group (NEDMDG)

06.12.2019 - 06.12.2019

All News & Events

Resources

Validation of an IFNg Elispot Assay in the Bioanalytical Laboratory

Scientific Poster

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White Papers

Aegyris The Simple and Efficient Solution for the Validation of Immunogenicity Assays to Support Vaccine Clinical Trials

Scientific Poster

All Resources