Say goodbye to local directories and any other non-validated document management solutions! With the BSI eTMF you have an instant overview of your trial master file documents. It stands out with its comprehensive eTMF functionality, providing trial master file management, document plans, reviews and approvals, exports, archiving, and more.
Study Design
Individually set up your clinical trials in the BSI eTMF according to the study protocol.
- Flexible study data setup with high-level information for phase 1-4 trials, including therapeutic area, cost estimate, number of planned sites and patients
- Interventional and non-interventional studies
- Umbrella function allows for grouping within clinical trial program and indications (diseases)Group trials below products and indications (diseases)
- Regions and countries
- Trial teams
- Involved organizations
Trial Master File (eTMF)
Set up your individual trial master file structure or use the TMF reference model from CDISC.
- 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 metadata for all eTMF documents, for example: granting rights, review and approval workflows, required signatures, etc.
- Enhance the document metadata with your own additional fields
- Organize documents in folders
- Create document plans: document placeholders will be automatically created for each document listed in the plan
- Configure document templates for any category you need
Work With Your Trial Master File
With the BSI eTMF, your study partners will find working on the trial master file documents easy and enjoyable.
- Upload, link, and save documents
- “Drag & Drop” emails into your trial master file
- View documents with the integrated document viewer functionality
- Create and upload new versions
- Set up 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 metadata cover page for each document, including audit trail information
- Optional PDF/A document conversion by download
Trial Closure and Reporting
The BSI eTMF empowers every user with our unique flexible reporting functionality. Easily create your own document reports using all the available data. You can also export your reports to Word or Excel. Want to save some time? Use our pre-configured reporting options.
- Search documents using the ‘Global Search’ function
- Get complete status of documents on trial, country and site level, among others
- 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
BSI Portal
Use the BSI Portal to connect your eTMF with study centers (sites).
- Plan the documents that will be part of the sponsors eISF (Investigator Site File)
- Give the site personnel access to easily upload or view documents
- Plan and execute document trainings, site personnel can perform and confirm with their electronic signature
