Electronic Trial Master File System (eTMF)
Complete Visibility into All Clinical Trial Documents
Bring Real-time Quality, Completeness and Timeliness into Your Clinical Trial Documents
LifeSphere electronic Trial Master File (eTMF) system streamlines inspections, ensures compliance readiness, and improves efficiency from study start to close-out. As the first system to support the open eTMF exchance mechanism standard, LifeSphere eTMF brings real-time quality, completeness, and timeliness to the cloud. The system is unified with LifeSphere Clinical Trial Management System (CTMS) and LifeSphere Clinical Platform. LifeSphere eTMF offers everything an emerging organization needs to manage trial documents in a simple, cloud solution that delivers eTMF with the benefits of an integrated CTMS.
Streamline eTMF Inspections
Quickly and effectively respond to inspection requests at any point in the clinical trial, including study closeout and archiving, with on-demand access to all TMF trial-related information and a clear view of expected documents by milestone status.
Ensure GCP compliance with out-of-the box embedded workflows and dashboards that allow authorities to easily reconstruct the trial. Leverage industry best practice processes to ensure your eTMF tells the complete story.
Save Time and Effort With Your eTMF
Replace time-intensive manual tasks with automated workflows, giving stakeholders confidence in existing documents, processes, and data so they have time to focus on what matters most.
Delivering Real Results to a Global Client Base
Of Top 50 Biopharmas
80% of the top 50 biopharma companies are our clients
Leader in Life Sciences
Building software to streamline life sciences innovation
100% compliance with all present and upcoming regulatory standards
LifeSphere eTMF: visible, easy to manage, inspection-ready.
LifeSphere eTMF is an easy to use clinical trial document management solution that streamlines inspections, future-proofs compliance, and saves time and effort for all stakeholders, from study start-up through closeout.
The Evolving Role of CTMS in Risk Management
Getting Connected: The Benefits of a Unified Clinical Platform
As the pressure to achieve faster, most cost-effective results, and to tap into new technologies to expand capabilities mounts, clinical operations will need a more progressive approach to managing every aspect of the clinical trial. A unified platform is the way forward.
The Clinical Domain is Evolving. Make Sure your CTMS is Evolving with It.
The Evolving Role of CTMS in Risk Management takes a broad look at the challenges facing clinical trial management, how the clinical domain is changing, and how the industry can better respond.
Partnering With the Industry’s Best
Fast, Easy TMF Planning
Our template-driven approach expedites TMF planning by ensuring alignment on expected document types. Quick and easy process to apply refinements to Yes/No and expected document counts.
Inspection-Ready TMF Viewer
Easy and intuitive hierarchy and viewer make browsing LifeSphere eTMF a breeze for internal consumers and auditors alike.
Global Search for Increased Productivity
As easy and quick to use as Google or Amazon, our global search returns your related documents and date records ranked by relevance.
Flexible and Easily Configured
Configurable watermarks, headers and footers, combined with the ability to have multiple rendition options per document type, provide limitless options to meet all your business needs.
User-, role-, and group-based security rules ensure consistent, reliable security across organizations of any size, outsourcing or service model.
Fast, knowledgeable teams adhere to industry best practices to get your teams up and running within 4-6 weeks.
Streamline Cross-Functional Collaboration
Unified with LifeSphere EasyDocs for content management, enabling real-time eTMF visibility across all departments. Easily connects with existing systems via open architecture, leveraging API connectors, and web services.
With full audit trails and 21 CFR Part 11 compliant eSignatures you gain a turn-key solution ready for Life Sciences companies of all sizes.
Unified eTMF and CTMS Platform
CTMS project plan milestones drive expected documents. Document progress drives milestone statuses. With a unified eTMF and CTMS you have a real-time understanding of both your eTMF and your study status.