Trial Documentation made better

McDougall manages your trial documents with the same sophistication as it manages your data. Using accepted standards – i.e. The Trial Master File Reference Model (eTMF-RM), or your custom document architecture, certified document managers work with you to document your unique needs in the eTMF Plan.

The resulting eTMF validated repository:

• Provides access control – from ‘read-only’ (only view the reports) to full rights to upload documents and easily ‘file’ them via easy to use meta data fields.
• Documents progress through a Sponsor-driven QA/QC lifecycle until approved
• All documents can be monitored through the lifecycle with pre-programmed views, email alerts and status reports to ensure ongoing audit readiness
• Navigation is intuitive and familiar and is fully integrated with your Outlook e-mail system, not only for notifications, but for document retrieval and filing.
• At the end of the trial, the completed approved and fully documented eTMF can be exported electronically to easily integrate into your submission software
• McDougall can also arrange for long-term digital archiving options if requested.

Trial documentation made better, through ongoing transparency and validated processes. Managing your research information is what we do – and we do it very well.