Cloudbyz eTMF is designed so that filing is quick, QC is focused and documents are easy to find: drag-and-drop upload, one-click folder creation, AI-suggested classification, dashboards for completeness and timeliness, and portals for sponsors and sites. Because Cloudbyz eTMF is built natively on Salesforce, it uses a familiar interface and shares one login with Cloudbyz CTMS, EDC and CTFM. It is used by teams at emerging biotechs, large pharma, global multinationals, CROs and device companies.
When filing is slow or confusing, documents stay in email and shared drives until someone has time, and the TMF falls behind. The EU expects the TMF to contain the essential documents at all times and to be readily available to inspectors (EMA TMF guideline), so usability directly affects compliance.
|
Role |
What they see and do |
|---|---|
|
TMF managers |
Completeness, timeliness and QC dashboards; QC queue with flagged issues |
|
CRAs and study teams |
Drag-and-drop filing; signed monitoring reports filed from CTMS automatically |
|
Sites |
Controlled access to share and review documents |
|
Sponsors working with CROs |
Portal access to their own studies' documents |
|
QA and inspectors |
Fast search and retrieval, with metadata and audit trail |
According to Cloudbyz, role-based training is part of every implementation, each go-live includes two weeks of hypercare, and ongoing support is included, with premium and 24x7 options.
The Cloudbyz team can walk through Cloudbyz eTMF as a TMF manager, CRA or sponsor. Book a demo or visit cloudbyz.com.