Celerion Protocols for Safe Clinical Research. Learn More

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

Get Your Drug to Market Faster.

Partner with us to get fast, actionable data you can rely on.

Related to "eTMF"

News & Events

AAV Vector Shedding Assay— Best Practices in Clinical Gene Therapy Method Development

06.20.2023 - 06.20.2023

Celerion Receives a 2023 CRO Leadership Award in All Categories for the Eighth Year Running

05.10.23

Alternatives for Rifampin as a CYP3A Inducer in DDI Studies in View of N-Nitrosamine Impurity Issues

06.14.2023 - 06.14.2023

All News & Events

Resources

Onsite Pharmacy Compounding for Your Phase 1 Clinical Study Webinar

Webinar

Global Cell and Gene Therapy Services Overview

Fact Sheet

The impact of N-nitrosamine impurities on clinical drug development: Drug-Drug Interaction Studies

Presentation

All Resources