GlobalTMF

Mission3's electronic Trial Master File solution, GlobalTMF, enables the comprehensive electronic searching and viewing of TMF documentation in accordance with ICH guidelines and 21 CFR Part 11.

Mission3’s electronic Trial Master File solution, GlobalTMF, enables the comprehensive electronic searching and viewing of TMF documentation in accordance with ICH guidelines and 21 CFR Part 11. GlobalTMF follows the DIA best practices for the Trial Master File Reference Model that spans 233 different document types across 11 zones (trial management, central trial documents, regulatory, IRB/IEC and other approvals, site management, IP and trial supplies, safety reporting, centralised testing, third parties, data management, and statistics).

Total clinical trial document management

When Mission3 talks about Global eTMF we mean much more than just clinical trial documentation storage. Easy to use but powerful document management is critical to ensure both user acceptance and compliance of your trial master files. GlobalTMF encompasses everything related to a clinical trial document’s lifecycle, which promotes greater compliance with your SOPs, improves process efficiency and drives control of study cost and quality.

Health authority compliance

Gain control over documents, better allocate resources, and reduce the time to market.

Remain compliant with Health Authorities and ensure the conduct of a trial and the quality of the data produced.

• 21 CFR Part 11 compliant
• Utilizes repositories defined in the Drug Information Association’s (DIA) best practices for Electronic Trial Master Files (eTMF Reference Model)
• Proves the validity of your trial conduct and the integrity of data collected and that the investigator, sponsor, and monitor complied with Good Clinical Practices (GCP) and applicable regulations throughout the clinical trial.
• All of your clinical documents are in one place, clearly organized, backed up electronically, and visible over the Internet from anywhere any time of day.

Realise the value of an out-of-the-box, cloud-based, SaaS as related to the bottom line. The cost of scalability, hosting, reliability, security management, IT support costs, networking becomes the responsibility of the SaaS provider. Implementation is quick and easy and utilises industry best practices for meta-data capture so few decisions are needed. Mission3 can even scan, index, and archive your documents for you so you can continue business as usual while we build your eTMF in the background.

The key functions of GlobalTMF centre around its full document management capabilities and include extensive searching, check in/check out, version control, audit trail, workflows, lifecycles, tracking and reporting, etc.