LIFESPHERE®
Among the Best eTMF Systems in the Market
Key eTMF Software Features
Fast, Easy TMF Planning- Inspection-Ready TMF Viewer
- Global Search for Increased Productivity
- Flexible and Easily Configured
- Enterprise-Grade Security
- Worry-Free Implementation
Fast, Easy TMF Planning
Everything an Emerging Organization Needs to Manage Trial Documents in a Simple, Cloud Solution
LifeSphere 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 exchange mechanism standard, LifeSphere eTMF (electronic trial master file) software 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.
BENEFITS
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.
Future-Proof Compliance
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.
RESULTS
Delivering Real Results to a Global Client Base
80
%
Of Top 50 Biopharmas
80% of the top 50 biopharma companies are our clients
30
years
Leader in Life Sciences
Building software to streamline life sciences innovation
100
%
Compliance
100% compliance with all present and upcoming regulatory standards
FEATURES
Fast, Easy TMF Planning
Our template-driven approach expedites trial master file 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.
Enterprise-Grade Security
User-, role-, and group-based security rules ensure consistent, reliable security across organizations of any size, outsourcing or service model.
Worry-Free Implementation
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.
Complete Compliance
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.
PARTNERS
Partnering With the Industry’s Best
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