11 December 2025
Integrations
While integration of eTMF with other systems offers great value, achieving it successfully requires careful planning, standardization, and change management. Here’s a practical guide to doing it right.
Start with an eTMF solution that offers well-documented, standard APIs (e.g. RESTful), supports metadata exchange, and allows configuration for folder structures, workflows, and user roles. This flexibility makes it easier to connect with CTMS, EDC, safety, and QMS tools.
Integration only works smoothly if all systems “speak the same language.” Establish a shared data model and metadata taxonomy (for documents, subjects, sites, versioning, status, etc.). Use widely accepted reference models — for example, the common document classification models for TMF content — to ensure consistency across systems and stakeholders.
Integration must align with how your organization manages trial operations. Define when and how data/documents are transferred, who approves or reviews them, how version control and audit trails are handled, who has access, and how exceptions (e.g. missing data, QC failures) are managed. Well-documented Standard Operating Procedures (SOPs) ensure clarity and compliance.
Before going live, perform integration testing to confirm data integrity, metadata mapping, error handling, and system performance. Validate that audit trails, version control, user permissions, and data synchronization work correctly. This is especially critical for compliance with regulatory requirements.
Transitioning from separate systems (or paper-based workflows) to integrated eClinical platforms requires user training, stakeholder buy-in, and effective change management. Staff must understand how integration affects their workflows, use of the system, responsibilities for uploading/approving documents, metadata input, etc. Without user adoption, even a technically sound integration can fail.
Once integrated, actively monitor system performance, audit logs, document completeness, metadata accuracy, and compliance with SOPs. Periodic audits help catch discrepancies early. Maintain version control, backup practices, and access control to safeguard data integrity.
If you’re moving from legacy or paper-based systems, consider running the new integrated setup in parallel initially. Migrate a subset of trials first, validate workflows, gather feedback, then scale up. This phased approach reduces risk and improves user comfort.
