Collaborate and Digitally Streamline Trial Master File Documentation Across Studies and Sites using Sentinel eTMF
With increasing concerns on patient safety, Regulatory agencies expect sponsors to have clinical sites audit-ready with an accurate Trial Master File (TMF) to account for all trial activities and provide complete visibility on the trial conduct progress with complete documentation. Regulators such as the European Medicines Agency and Medicines & Healthcare Products Regulatory Agency (MHRA) expect, at a minimum, that an organization’s TMF accurately reconstructs how a clinical trial was conducted to demonstrate effective sponsor oversight, support decisions made, and comply with GCP guidelines.
Key Solution Capabilities
- Sentinel eTMF offers a secure and centralized digital collaboration space
- The platform has robust search and document retrieval and content viewing capabilities
- Allows users to quickly find and access documents based on user role permissions
- Facilitates the management of a wide-variety of clinical trial documents in varying size and formats.
- Allows sponsors to setup flexible metadata configurations to optimize Trial Documentation Management
- Provides stakeholders a comprehensive oversight on the progress of milestones and related TMF documentation
- Has powerful features to facilitate electronic records import and export
- Facilitates fast and accurate data exchange between other source document systems like EDC, CTMS, etc.
- Sentinel eTMF maintains the confidentiality and integrity of the data along with authorized access controls, single sign on (SSO) and active directory integrated thus making it regulatory 21 CFR Part 11 compliant cloud platform.
- The documents and data are handled with multiple protection privacy in the areas of patient safety, data protection and security.
- Has time-based and event-based built-in alerts and notifications
- Allows tracking milestone progress and ensuring that all relevant clinical trial documents are complete and maintained in a compliant manner.
- Leverage standard reports to gain insights on documentation progress, open issues and overall quality
- Keeps users informed on critical timelines, document status, key risks and activities summary
Stay Audit Ready with Sentinel eTMF
How We Deliver
Sentinel eTMF is offered as a fully-managed SaaS solution to pharma companies, CROs and other life sciences organizations. Clients can leverage our pre-validated platform to rapidly begin the eTMF setup. Our team of specialized consultants will provide extended knowledge support for the eTMF implementation and rollout.