Say goodbye to local directories or any other non-validated document management solutions. With BSI eTMF you have an instant overview of your trial master file documents. It stands out with its comprehensive functionality, providing trial master file management, document plans, reviews and approvals, exports, archiving and a lot more.
Individually set up your clinical trials in BSI eTMF according to the study protocol.
- Flexible study data setup with high-level information for phase 1…4 trials, such as, therapeutic area, cost estimate, number of planned sites and patients
- Group trials below products and indications (diseases)
- Regions and countries
- Trial teams
- Involved organizations
Setup your individual trial master file structure or use the TMF reference model from DIA.
- Optimize the trial master file structure per trial or (as a CRO) per sponsor
- Keep the sponsor TMF and Investigator Site File (ISF) in one place
- Define the required meta data for all documents of the eTMF e.g. granting rights, review and approval workflows, required signatures …
- Enhance the document meta data with your own additional fields
- Organize documents in folders
- Create document plans. Document placeholders will automatically be created for each document listed in the plan
- Configure document templates for each category where required
Your various study partners will enjoy working on the trial master file documents using BSI eTMF.
- Upload, link or save documents
- Drag & Drop e-mails into your trial master file
- View documents with the integrated document viewer functionality
- Create and upload new versions
- Setup review and approval workflows
- Review, approve and electronically sign documents
- Document deadlines with alerting function
- Download individual documents or the complete trial master file with a meta data cover page for each document, including audit trail information
- Optional PDF/A document conversion by download
BSI eTMF empowers every user with our unique flexible reporting functionality. Create your own personal document reports using all available data in BSI eTMF by pure configuration and export the data to Word or Excel. Or simply use the out-of-the box reports.
- Search documents using the Global Search function • Get completeness status of documents on e.g. trial, country and site level
- Create general document reports for all users or for specific user groups
- Export documents according to the trial master file structure in a ZIP file including cover pages
- Limited access to inspectors and auditors of the eTMF
Use the BSI Portal to connect your eTMF with the study centers (sites).
- Plan the documents that shall be part of the sponsors eISF (Investigator Site File)
- Give the site personnel access to easy upload or view documents
