Sponsor
Records of the sponsor's own trial activities.
- Protocol and amendments
- Regulatory submissions and approvals
- Monitoring plans and reports
Healthcare / Clinical Trials eTMF
Clinical trials eTMF software that stays inspection ready
A trial master file fails an inspection when records are late, misfiled or missing a signature, not when the software lacks features. Agnotic Technologies builds eTMF software that classifies each record on upload, routes it through quality checks and shows what is still missing for every site and milestone.
TMF Standard Model
Classification adapted to your SOPs
Expected lists
Missing records shown per site
Read-only access
For monitors, auditors and inspectors
Trusted by global innovators
Industry Overview
What is an eTMF?
An electronic trial master file (eTMF) is the system that holds a clinical trial's essential records, such as protocols, approvals, site and sponsor documents, filed, quality checked and kept ready for inspection and archiving. Agnotic Technologies builds clinical trials eTMF software with TMF Standard Model classification, completeness tracking, site workflows and retention controls.
Who files
Who files what in a trial master file?
Essential records come from several parties. The eTMF has to know who owns each record, who may see it and where the original is kept.
CRO and service providers
Records for activities the sponsor has transferred to them.
- Filing under the sponsor's structure
- Access agreed for the life of the trial
- Hand-back at study close
Investigator site (ISF)
Records the investigator or institution generates and controls.
- Signed consent forms and source records
- Delegation and training records
- Site copies of sponsor safety information
Vendors with trial systems
Records behind the systems used in the trial.
- Validation records for trial systems
- Data transfer agreements
- IRT, eCOA and lab documentation
Industry Challenges
What do inspectors find in a weak TMF?
The same failure points come up again and again. Most are process problems the software can prevent.
Late filing: records uploaded months after the event, so the TMF does not show how the trial was run at the time.
Misclassification: a record filed under the wrong artifact cannot be found when an inspector asks for it.
Version gaps: a superseded document replaced with no history, so nobody can show which version was in use.
Missing signatures or dates: records filed without the approval they need, discovered at QC or at inspection.
Unknown locations: records held in another system or at a vendor, with no record of where they are.
Our Approach
How should eTMF records be classified?
Classification decides whether a record can ever be found again. These are the rules we build around.
One taxonomy, adapted
Zones, sections and artifacts follow the TMF Standard Model, adapted to your SOPs and agreed before the first upload.
Metadata at upload
Study, country, site, artifact, version and document date captured when the record arrives, not added later.
Suggested, then confirmed
Classification can be suggested from the content, but a person confirms it before the record is filed.
Location of every record
Records kept in another system are listed with where they are held, so the TMF stays complete.
Capabilities
What does an eTMF system do?
Modules we build for an eTMF, alone or connected to the trial systems you already run.
Upload and classification
Single and bulk upload, scanned paper capture and classification to your artifact list.
Quality control workflow
A review step for each record, with findings sent back to the person who filed it.
Completeness tracking
Expected records by study, country and site, with missing and overdue items shown.
Site exchange
A portal for sites to send records and receive sponsor documents, while their own ISF records stay under their control.
Inspection access
Read-only, time-limited access for monitors, auditors and inspectors, with every view logged.
Archive and retention
Study close, archiving with full history and retention dates set per record type.
How It Works
What happens to a record from upload to archive?
The path we build for every essential record. Each step is recorded with who did it and when.
Capture
A record arrives by upload, scan, email capture or a feed from another trial system.
01
1
Classify and describe
The filer confirms the artifact and adds the metadata the taxonomy requires.
02
2
Quality check
A reviewer checks the record is complete, legible, signed and dated where needed, and correctly classified.
03
3
File
The approved record is filed, earlier versions are kept, and the expected list for that site updates.
04
4
Use during the trial
Study teams, monitors and sites see the records their role allows, and inspectors get read-only access.
05
5
Close and archive
At study close the TMF is reconciled, locked and archived with its audit history and retention dates.
06
6
Engineering Stack
Standards and technologies behind an eTMF
The taxonomy, document handling and platforms behind the eTMF software we build.
Taxonomy
CDISC TMF Standard ModelYour SOP-specific artifact list
Documents
PDF rendering and archiving formatsOCR for scanned recordsElectronic signatures
Backend
Node.jsPythonPostgreSQLObject storage with versioning
Infra
AWSAzure
Completeness table
Which records should the eTMF expect, and when?
An example of the expected-record list we configure. Your trial design and SOPs decide the real list; ICH E6(R3) notes that some essential records should generally be in place before the trial starts.
| Stage | Example records | Who usually files | What the eTMF checks |
|---|---|---|---|
| Before the trial starts | Investigator's Brochure, signed protocol, IRB/IEC approval and composition, sample case report forms and participant information | Sponsor or CRO | Present and approved before site activation |
| Site activation | Site staff qualifications, delegation records, site approvals | Site, through the exchange portal | Present for each site before its first participant |
| During the trial | Protocol amendments, safety notifications, monitoring reports, investigational product shipment records | Sponsor, CRO and sites | Filed within the agreed time and in the current version |
| Participant level | Signed and dated consent forms, enrollment log | Site, in the ISF | Location recorded; originals stay with the site |
| Close and archive | Product accountability and disposition, final reports, clinical trial report | Sponsor and sites | Reconciled, locked and given retention dates |
Measured Impact
How healthy is the TMF?
Measures we build into the TMF dashboard, agreed with your clinical operations lead.
Completeness
Expected records filed
By study, country and site.
Timeliness
Event to filing
How long records take to reach the TMF.
QC findings
Records returned at review
By finding type, so training targets the right people.
Open items
Missing or overdue records
Assigned to an owner with a due date.
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Use Cases
Who builds an eTMF with us?
Teams whose trial records need a structure shaped to their own processes.
01
Sponsors moving off paper or shared drives
A first eTMF built around the SOPs they already follow.
02
CROs
One eTMF across many sponsors, with each sponsor's structure kept separate.
03
Site networks
Electronic investigator site files across many research sites.
04
Device and diagnostics sponsors
Trial records alongside device-specific documentation.
05
Academic trial units
Investigator-led trials that need an inspection-ready TMF.
06
eTMF for startups
Clinical trials eTMF for startups building a trial operations product or service.
Integrations
Systems an eTMF connects to
The systems that send records to the eTMF or read its status.
Milestones and sites
CTMS
Data management records
EDC and CDMS
Supply and unblinding records
IRT
Safety notifications
Safety database
Approvals
Electronic signature
Intake
Document capture and email
Compliance-First Development Services Backed by Global Standards
We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.
General Data Protection Regulation
Implement lawful consent flows, data minimization, and secure processing for global data privacy.
Our Edge
Why Global Leaders Choose Us
We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.
Enterprise-Grade Security
We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.
High-Performance Scaling
Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.
Accelerated Time-to-Market
Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.
Embedded AI Integration
Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.
Engagement Model
How does an eTMF project run?
How to build clinical trials eTMF software around your existing SOPs. Timing depends on scope, and we agree a fixed first release on the scoping call.
01
Scoping call
We agree the studies, the parties who file, the systems to connect and any records to migrate.
02
Taxonomy workshop
Your artifact list mapped to the TMF Standard Model, with metadata and expected lists agreed.
03
Fixed-scope first release
Upload, classification, QC and completeness tracking for one study.
04
Sites, archive and migration
Site exchange, inspection access, archiving and migration of records from paper or another system.
05
Validation and support
Specifications and test evidence for your validation team, then support under agreed terms.
Facts and sources
Which rules and standards shape an eTMF?
Short facts behind trial master file software, each linked to its primary source.
ICH E6(R3) says essential records should be kept in repositories held by the sponsor and by the investigator or institution, which may be called the trial master file (TMF) and, at the site, the investigator site file (ISF).
Source: ICH E6(R3), Appendix C.2.3 (ICH)ICH E6(R3) says sponsors and investigators should keep a record of where essential records are located, and that storage systems used during the trial and for archiving should provide identification, version history, search and retrieval.
Source: ICH E6(R3), Appendix C.2.4 (ICH)ICH E6(R3) says essential records should be retained so they stay complete, readable and readily available, directly accessible on request by regulators, monitors and auditors, and any alteration should be traceable.
Source: ICH E6(R3), Appendix C.2.6 (ICH)CDISC describes the TMF Standard Model, formerly the TMF Reference Model, as a standardized taxonomy and metadata for TMF content that can be adapted to an electronic or paper TMF and does not require any specific technology.
Source: CDISC, Trial Master File StandardUnder 21 CFR 312.57(c), an IND sponsor must retain its required records and reports for 2 years after a marketing application is approved for the drug or, if it is not approved, until 2 years after shipment and delivery for investigational use is discontinued and FDA is notified.
Source: 21 CFR 312.57(c) (eCFR)
Voice of success
We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.
“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”
Aaron Phelan
Founder, Benchmark
“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”
John Pasmore
Founder, Latimer
“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”
Kim Smith
Founder, My Lauren
Related services
Related clinical trial and document services
Pages for the systems around the trial master file.
Clinical trial management software (CTMS)
The operational layer: sites, subjects, visit schedules, enrollment and monitoring.
Life sciences and clinical trial software development
The wider view of study software: recruitment, eConsent, participant apps and Part 11 controls.
Medical document processing automation
Scanned and faxed documents turned into classified, searchable records.
HIPAA requirements for software teams
The safeguards we build into every system that holds patient data.
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The technical patterns behind this platform translate naturally into adjacent verticals.
Frequently Asked Questions
No. CDISC states that organizations are under no obligation to adopt it, and that it is meant to be adapted rather than used off the shelf. Most teams start from it because it gives a shared structure with CROs and auditors.
It depends on the regulations that apply to the trial. For a US IND, 21 CFR 312.57 and 312.62 set sponsor and investigator retention periods tied to marketing approval. We build retention dates per record type, set by your regulatory team.
They can, as long as records the investigator generates stay under the investigator's control. We build site areas with their own access rules, so the sponsor sees only what it should.
Yes. We map your current structure to the new artifact list, move records with their metadata and versions, and produce a reconciliation report so nothing is lost. Copies that replace originals follow your certified copy process.
With HIPAA-ready engineering: encryption, role-based access, logged views and downloads, and hosting in your cloud account where needed. Records with participant information, such as signed consent forms, stay in the site area. Agnotic signs a business associate or data processing agreement where needed.
The number of studies and filing parties, the taxonomy work, integrations with CTMS and other systems, migration from paper or another eTMF, and the validation evidence your quality team needs. We describe these drivers on the scoping call rather than quote a price before it.
It depends on scope. We agree a fixed first release on the scoping call, usually upload, classification, QC and completeness tracking for one study, and give you a timeline for that release.
AI tools help our engineers draft code and tests. An engineer reviews every change, and every release is tested against the requirements and test scripts your validation team signs off.
Industries