IQVIA Electronic Trial Master File (eTMF) delivers a high performance, turnkey solution. This software-as-a-solution for SaaS is easy to access, monitor, manage and maintain for all your global stakeholders. IQVIA eTMF is
Promotes inspection-readiness to simplify regulatory compliance
Supports accountability with completeness, quality and timeliness views
Trusted by sponsors and CROs of all sizes
Eliminates redundancy and improves transparency by providing a unified platform
The specific structure, strategy and schedule of your trial are the backbone of your customized eTMF solution. Once it is set up, dashboards and detailed reports give you visibility in real time and guidance to help address issues and improve efficiency.
Site-level documents account for more than 80% of the average trial master file.
SiteZone lets you start up portals for all sites, those within a specific country, or select sites. It manages user accounts and doesn’t put a large burden on your IT staff.
SiteZone automatically requests documents as they are due and can gather electronic signatures from site personnel in place of ink and paper signatures. It also reduces or eliminates many of the routine tasks that can consume your CRA's time, including documents handling, tracking and reconciliation.
IQVIA offers a secure global archiving solution with validated backup and disaster recovery. eArchive provides inspector access at the study, country or site level in just a few minutes, and is remotely accessible by your authorized users and inspectors at all times.
eArchive is annually certified for both SSAE 16 Type II and ISO 27001.
IQVIA lets you capture timely, accurate information directly from each region and share it globally. Our regulatory information system gives you the ability to manage regulatory information from correspondence and commitments to submissions, registration and tracking.
IQVIA regulatory information management is simpler – often eliminating manual data entry and spreadsheets. It’s scalable, creating and validating multiple submissions across global sites. And it’s more efficient, providing unified, real-time access to relevant submissions, commitment information and registration and tracking across your product portfolio.
Move to streamlined, risk-based processes to manage clinical, commercial and regulatory content.