Electronic Trial Master File (eTMF) System
The electronic Trial Master File (eTMF) is an application which leverages software and server technology to guide and assist the setup, collection, storage, tracking and archival of essential clinical study documents.
The Trial Master File (TMF) is a structured collection of documents for a clinical trial to show evidence of regulatory compliance, allowing the conduct and quality of data collection to be evaluated. TMF contains study level, country level and site level documents, and those documents are collected at multiple points during the study (e.g. startup to study close). A related feature set, the electronic Investigator Site File (eISF) portal, can work in conjunction with your eTMF to facilitate document exchange between sponsor/CRO and sites.
| FREE UP YOUR INTERNAL TMF RESOURCES | OPTIMIZE PROCESSES & QUALITY | MAKE YOUR eTMF SYSTEM WORK FOR YOU |
|---|---|---|
| Leverage seasoned Trial Master File (TMF) Study Owners anytime anywhere. Obtain pragmatic training on TMF best practices & technology. Conduct efficient, accurate TMF migrations & imports at any scale. | Get a holistic view of completeness, timeliness & quality. Pinpoint & correct TMF completeness gaps. Embed TMF best practices around quality control & compliance. Obtain expert guidance for SOPs & eTMF technologies. | Align TMF technology with your people & processes. Leverage your eTMF to develop & automate better TMF workflows. Obtain hands-on, system-specific eTMF training. |
Features of ERIC ETMF
| TMF Completeness Heatmaps | TMF Quality Review | TMF Document Processing |
|---|---|---|
| Easily identify potential TMF problem areas in any eTMF system and enable a risk-based remediation approach. | A thorough quality assessment of your TMF, giving you detailed insight into its quality and completeness. | Ensure completeness, accuracy, and consistency from source to archive - regardless of your eTMF provider. |
| TMF Study Owners | TMF Consulting Services | Migrations & Imports |
|---|---|---|
| Our TMF Practitioners have successfully mastered the challenges you and your teams face every day. | Our expert TMF consultants help your company reach and stay in the TMF Health Zone. | Help ensure you are meeting GCP standards and regulatory requirements for essential documents |
| TMF Expert Training | eTMF Health Dashboard | Full-Service Trial Master File Management |
|---|---|---|
| Generate lasting benefits to your team and improve the overall health of your TMF | For inspection-readiness, the critical attributes of TMF health are completeness, timeliness, and quality. To achieve and maintain ongoing TMF health and inspection readiness – the “TMF Health Dashboard” – requires experienced people trained on effective processes using the right technology | The Industry’s Only Turnkey, End-to-End TMF Outsourcing Solution from a Single Expert Provider. |