Electronic Trial Master File
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. The TMF must provide complete visibility on the trial conduct progress with complete documentation. Regulators such as the European Medicines Agency (EMA) 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.
Introducing Compier eTMF
Compier eTMF is a highly configurable GxP compliant digital Trial Master File (TMF) management solution that allows sponsors to develop, track, share, and manage all types of clinical trial documentation as per the TMF Reference Model for Trial Master Files, the EDM Reference Model for Regulatory Documents and the ICH eCTD model for Regulatory Submissions.
With the goal of establishing lean and insights driven Trial Master File (TMF) management across clinical sites, the Compier platform has modern technology capabilities to enable sponsors take informed decisions and always stay audit ready for regulatory inspections.
Our platforms helps sponsors to establish a comprehensive Digital Trial Master File with the following capabilities:
- Ensuring accuracy and completeness of electronic clinical trial documentation in the chronology order
- The platform has robust search and document retrieval and content viewing capabilities to quickly find and access documents based on user role permissions
- Managint the eTMF as per the standardized taxonomy of the TMF Reference Model using standard nomenclature.
- Allows sponsors to setup flexible metadata configurations to optimize Trial Documentation Management
- Facilitates fast and accurate data exchange between other source document systems like EDC, CTMS, etc.
- Provides stakeholders a comprehensive oversight on the progress of milestones and related TMF documentation
Key Features & Benefits
> Compier eTMF allows tracking milestone specific clinical trial documents are complete and maintained in a compliant manner.
> Facilitates the management of a wide-variety of clinical trial documents in varying size and formats.
> 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
> Compier eTMF maintains the confidentiality and integrity of the data along with authorized access controls
> The documents and data are handled with multiple protection privacy in the areas of patient safety, data protection and security.
Solution FAQs
Compier 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.
Yes, the Compier eTMF platform is a fully-managed cloud solution which is validated for 21 CFR Part 11 compliance. We will be providing the validation package at the time of cloud onboarding to clients.
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