eTMF

Simploud's Trial Master File (eTMF) solution is designed to help life sciences organizations manage their TMF with confidence, keeping it complete, current, and inspection-ready from the very first day of a study. Managing a TMF across multiple stakeholders and sites is inherently complex, and disorganized files, missing documents, or inconsistent timelines can pose serious risks to trial integrity. Simploud addresses these challenges by bringing structure and order to the entire TMF process through configurable workflows and built-in compliance logic.

The platform is purpose-built for organizations operating in regulated environments — including pharmaceutical, biotechnology, medical device, CRO/CDMO, and digital health sectors — where GCP compliance and audit readiness are non-negotiable requirements.

Key Compliance and Standards Alignment

• Aligns with the DIA Reference Model and Good Clinical Practice (GCP) standards to ensure the TMF structure meets industry expectations
• Built-in compliance logic reduces the manual effort required to maintain a standards-conformant file
• Supports inspection readiness as an ongoing, day-to-day state rather than a last-minute effort

Document and Workflow Management

• Tracks document versions, approvals, and timelines throughout the lifecycle of the trial
• Configurable workflows allow teams to tailor processes to their specific organizational and study needs
• Enables cross-stakeholder and cross-site collaboration on a unified, centralized TMF

Oversight and Risk Management

• Built-in audit trails provide a complete, tamper-evident record of all document activities and changes
• Role-based access controls ensure that only authorized personnel can view or act on specific documents
• Real-time flagging of gaps and overdue items helps teams proactively address compliance risks before they escalate

Simploud's eTMF is part of a broader platform described as secured, scalable, and compliant, with integration capabilities suited to the diverse needs of life sciences organizations. A free 15-day trial is available, allowing teams to evaluate the platform against their own specific use cases and workflows.