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Custom Electronic Trial Master File (eTMF) Software
Features, Development Process, and Investments
In healthcare IT since 2005, ScienceSoft engineers eTMF solutions for CROs, research organizations, pharmaceutical and biotech companies, and health systems. We deliver eTMF software that offers advanced document processing automation capabilities, provides instant visibility into document completeness and timelines, and ensures continuous readiness for regulatory inspections.
Electronic Trial Master File (eTMF) Software at a Glance
Electronic trial master file (eTMF) software provides a secure and structured environment for creating, organizing, and managing clinical trial documentation, tracking the progress of each document in real time, and preparing documentation for health authority inspection.
When it comes to eTMF, research organizations prioritize user-friendliness, comprehensive TMF analytics, and advanced document management automation. According to the 2023 TMF Industry Report, which surveyed 245 TMF professionals from contract research organizations (CROs), pharma, and biotech companies, the most desired improvements to today's eTMF systems include a more intuitive interface, better reporting capabilities, tracking of advanced TMF health metrics, and more sophisticated AI features.
Custom eTMF software is often chosen by research organizations that have faced the constraints of ready-made solutions:
- Inability to adapt the TMF structure to specific study SOPs and country-specific regulatory requirements.
- Insufficient scalability of the eTMF solution for handling complex multi-center or multi-country research.
- Limited ability to automate complex documentation management and collaboration workflows, e.g., labor-intensive document classification processes or efficient transfer of data to partners.
- Insufficient analytics capabilities, e.g., for tracking TMF completeness.
- Inability to integrate eTMF with multiple clinical trial systems, including legacy solutions.
Implementation time: from 5 to 10+ months.
Possible integrations for eTMF software: a clinical trial management system (CTMS), electronic data capture (EDC) software, a regulatory electronic document management system (EDMS), document collaboration software, an eSignature tool, and more.
Costs: $80,000–$300,000+, depending on complexity. Answer a few questions about your business needs, and our consultants will get back to you with a custom quote.
Main Capabilities of eTMF Software
Below, ScienceSoft provides an overview of an electronic trial master file system’s functionality that accommodates the key needs of our clients in life science R&D. In real-life projects, every solution has a unique feature set, as it is designed according to the specific requirements of the research organization.
eTMF study setup
- A wizard for setting up eTMF environment in line with study SOPs.
- Automatic generation of a new adjustable eTMF study plan based on the previously completed trials.
- Role-specific eTMF workspace customization.
- Specifying placeholders for country- and site-specific document uploads based on the reference model or customized templates
- Templates for building configurable document processing workflows.
- Defining task assignment rules.
- Setting up auto naming rules and configuring metadata.
TMF content creation and structuring
- Built-in TMF Reference Model defining the TMF structure, core and recommended documents, their properties, relationships, and hierarchies according to GCP standards.
- Creating, editing, and versioning documents in the TMF system.
- Document uploading and retrieval (including in bulk).
- Auto-populating TMF documents with data created and updated in CTMS and EDC systems (e.g., site qualification and initiation data extracted from CTMS).
- Automated generation and updating of an expected document list (EDL) that specifies missing documents.
- Duplicate document identification.
- Rule-based uploaded content standardization and verification for common errors.
- OCR (optical character recognition) capabilities to convert scanned documents or images into editable and searchable documents.
- AI-driven document metadata extraction (e.g., author, site, creation and modification dates, version number, etc.).
- AI-driven classification of uploaded documents into the correct TMF Reference Model folder.
TMF content viewing and searching
- Viewing the document catalog with a hierarchical folder structure (defined by the TMF Reference Model).
- Document filtering by country, site, partner, investigator, document type, status, due date, milestone, risk level, etc.
- Keyword search in document titles, content, and metadata.
- Viewing documents related to a particular trial phase or research event (such as protocol amendments or investigator brochure updates).
- Viewing document content in parallel with metadata.
- Ability to review all document versions and search through them.
- A customizable layout to resize, collapse, or view windows side by side (e.g., to view a document with metadata or versions of the same document).
Risk-based QC review
- Automated workflows for quality checks at the time points specified in the trial SOPs.
- Automatic assignment of risk levels to documents according to previous inspection and QC results with continuous real-time reassessment based on new data.
- Setting up risk tolerance limits for different document types, specifying when they should undergo QC.
- AI-driven document scanning for classification mistakes, blank fields, missing signatures and dates, illegible parts, PHI, duplicates, and other quality issues.
- Automatic confidence score assignment for every AI-driven quality check (based on QC specialists’ evaluation of model accuracy for different document types).
- Rule-based document assignment for QC specialist review according to confidence score and risk level.
TMF data exporting, migration, and archiving
- Data export to DOCX, XLSX, CSV, or PDF format.
- Automatic generation of files ready for health authority submission (e.g., investigator curriculum vitae and protocol training certifications).
- Transfer of the entire eTMF with audit trail information and relevant documents between sponsor and CRO systems.
- eTMF archiving according to ICH GCP, FDA, and EMEA document retention requirements, with support for searching, filtering, and reporting on archived content.
Analytics and reporting
- Role-specific dashboards for real-time tracking TMF completeness, timelines, and quality (e.g., the percentage of approved documents; the number of documents that didn’t pass QC, are missing, or are overdue, etc.).
- Built-in and ad hoc reports on document completeness, QC findings, adherence to timelines, etc., that can be exported.
- ML/AI-driven analytics to forecast TMF completion timelines and identify process bottlenecks (e.g., delays in getting documents from departments and partners).
Task management and team collaboration
- Real-time collaborative TMF document authoring on Microsoft Office platforms with version control.
- Customizable, automated workflows for document reviewing, e-signing, and approval.
- Task tracker with the ability to filter tasks by category, assignee, due date, status, and progress level.
- Creating announcements, notes, and comments for specific roles, individuals, or the whole team.
- Customizable notifications on task and document status updates.
- Alerts on overdue tasks and document deadlines.
- Role-based limited access to TMF documents for sponsor representatives (e.g., to oversee TMF inspection readiness) and auditors (to conduct audits directly in the software).
Regulatory compliance and data security
- Role-based access controls (multifactor authentication, access rights, action permissions, automatic logoff, etc.).
- Granular data access based on user roles and context (e.g., for individual reports, specific fields).
- Full data encryption at rest and in transit.
- Audit logs, including timestamps and detailed metadata on all user actions (e.g., document accessing, editing, approvals) to support traceability and accountability.
- Compliance with data privacy and security requirements outlined in HIPAA, HITECH, GDPR, and other applicable regulations.
- Support for workflows that ensure best practices in data quality management according to FDA Guidance on eTMF, EU Clinical Trial Regulation (CTR) 536/2014, EU Annex 11 (EMA), etc.
- Automated and semi-automated checks for data completeness, composition, and integrity according to ICH E6 (R2) guideline for Good Clinical Practice (GCP).
- Electronic document signing in compliance with FDA 21 CFR Part 11 requirements.
- Data protection from system failures, malfunctions, and accidents, with backup and recovery.
Possible Integrations for eTMF Software
- Clinical trial management system (CTMS) — to obtain data regarding site qualification, initiation, and monitoring, trial milestones, phases, visits, etc.
- Electronic data capture (EDC) system — to collect electronic case report forms (eCRF) with data on patient observations.
- Pharmacovigilance system — to include safety reports, such as adverse event line listings and summary tabulation reports, in the eTMF.
- Regulatory electronic document management system (EDMS) — to transfer documents intended for submission to regulatory authorities.
- Data analytics solution — to retrieve metrics for monitoring site performance, TMF completeness, quality, and timeliness; to forecast document completion timelines and identify potential risks or process bottlenecks; to investigate the root causes of bottlenecks.
Custom eTMF Software Development Process
Below, ScienceSoft’s experts share development steps and best practices to deliver robust electronic master file (eTMF) software while keeping the project’s budget and timelines under control.
1.
Requirement engineering
At this stage, business analysts work with the research organization’s executives, subject matter experts, and future software end-users from the site staff to define the optimal feature set suited to the company's needs.
For example, to address recurring TMF document quality issues, such as missing metadata, a medium-sized research organization might consider implementing a number of more basic features, like pre-configured metadata templates for different document types and mandatory field validation rules when uploading a document.
Meanwhile, a large pharmaceutical company with diverse divisions, external partners, and a high volume of documents might prefer to develop an AI/ML module to automatically check uploaded documents for missing metadata and auto-fill them.
Compliance experts analyze the internal processes of the research organization to create a list of features needed to support compliance with regulations like HIPAA, HITECH, GDPR, FDA 21 CFR Part 11, ICH E6 (R2) GCP, etc.
Planning features that support regulatory compliance requires careful analysis. For example, when planning the design of an electronic document signing service, we follow the FDA 21 CFR Part 11 guidelines, which specify that the reliability of an electronic signature must be equal to that of a signature on a similar paper document.
However, not all of the research organization’s documentation has to comply with this requirement. We work with the client to define the purpose of signatures for each document type. The costly digital signature technology, which ensures the authenticity and integrity of the document's contents, can be reserved for submissions. For internal documents, cheaper alternatives can be used, significantly reducing operational costs, as eTMF documents are signed in bulk.
2.
Architectural design
Software architectures analyze the functional and non-functional requirements documented during business analysis to select a suitable architectural type, define functional modules, and outline interactions between modules.
While designing eTMF software architecture, the specialists ensure it will support all the relevant regulatory requirements. For instance, to plan the implementation of features that will support compliance with FDA 21 CFR Part 11, architects choose logging frameworks for maintaining immutable audit trails and define mechanisms for implementing timestamp accuracy (e.g., NTP, blockchain).
Another essential factor architects consider when designing eTMF architecture and choosing suitable techs is performance, which becomes especially crucial for Phase 3–4 clinical trials, where the eTMF must process tens of thousands of large files.
When choosing integration methods to connect the eTMF solution with existing clinical trial software, architects consider that the integrations must support standardized health data formats HL7 or FHIR. This is usually done by developing FHIR APIs. If it isn’t feasible because of the limitations of the legacy systems, integrations can be implemented, for example, using a secure file transfer protocol (SFTP) that supports HL7 data transmission.
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3.
UX and UI design
Designers aim to create role-specific interfaces with easy access to all the automation tools. For example, to reduce site staff's manual data entry during document uploads, designers can ensure that tools like metadata auto-population, document auto-naming, and placeholder auto-generation are readily available directly in the upload interface.
Another important task is to make navigation convenient and the interface elements intuitive. To achieve this, designers can implement breadcrumbs navigation to let users easily track their position within the eTMF and side navigation with collapsible sections to let them view only the areas relevant to the current task. To gather feedback and make adjustments based on user needs and pains, designers may also involve future software users in usability testing during the prototyping stage.
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4.
Development and testing
At this point, developers code user interfaces, the back end of eTMF software (including advanced modules like the AI model for TMF document classification), and set up data storage.
Testing usually happens in parallel with development to identify and fix issues as quickly as possible. Solutions for clinical research, which are subject to strict regulatory requirements, demand particularly rigorous security testing. Another major priority is integration testing, as it’s necessary to ensure smooth data flows and prevent delays in uploading or updating large files in TMF.
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5.
Deployment and support
Before the solution goes live, developers run a pre-launch compliance audit to double-check the software's compliance with regulations. After the launch, they monitor the solution’s performance, resolve any remaining issues, and organize a knowledge transfer to the research organization’s support engineers, who will handle further eTMF software support and maintenance.
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How Much Does It Cost to Develop a Custom eTMF Software?
The costs for building a custom electronic trial master file software vary from $80,000 to over $300,000. The major cost factors include the number of integrations and the need for advanced analytics and AI capabilities.
Here’s an approximate estimate of the costs for building basic, standard, and advanced eTMF solutions, along with a summary of what they offer.
Basic
From $80,000
Main capabilities:
- Document uploading, versioning, viewing, filtering, searching, and exporting.
- Task tracker.
- Basic automated workflows for task assignment.
- Basic TMF readiness tracking.
- TMF archiving.
- Integration with EDC and CTMS.
Standard
From $150,000
In addition to the basic features:
- A wizard for eTMF study set-up.
- Automated workflows for document co-authoring, QC reviewing, and approval.
- Analytics for TMF completeness, quality, and timeliness metrics.
- Integration with regulatory EDMS.
Advanced
From $300,000
In addition to the standard features:
- AI-driven document classification.
- AI-assisted QC reviewing.
- Integration with 4+ systems (e.g., EDC, CTMS, regulatory EDMS, CRM, and LMS).
- Predictive analytics (e.g., to forecast TMF timelines).
Learn the cost of your eTMF software
ScienceSoft's experts are ready to provide a quote for your specific case.
Why Choose ScienceSoft for Your eTMF Project
- Since 2005 in healthcare IT.
- 150+ successful projects in the domain.
- Experience in meeting GCP, FDA, HIPAA, HITECH, and GDPR requirements.
- ISO 13485- and ISO 9001-certified quality management, ISO 27001-certified information security management.
- #1 in Healthcare Software Development according to the Black Book™ 2023 market survey.
Our Awards and Recognitions
Listed among Healthcare IT Service Leaders in 2022 and 2024
Growing faster than Amazon, Google, and ServiceNow
Recognized for reliability and trustworthiness
Recognized by Health Tech Newspaper awards for the third time
Top Healthcare IT Developer and Advisor by Black Book™ survey 2023
Best in class in medical device connectivity (2023)
A top outsourcing provider for three consecutive years
ISO 13485-certified quality management system
ISO 27001-certified security management system
ScienceSoft as a Reliable Partner for Healthcare Solution Development
bioAffinity Technologies hired ScienceSoft to help in the development of its automated data analysis software for detection of lung cancer using flow cytometry. We would recommend them as a trustworthy vendor.
During our cooperation, ScienceSoft proved to have vast expertise in the Healthcare and Life Science industries related to development of desktop software connected to laboratory equipment, a mobile application, and a data analytics platform.
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Founder and CEO
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