LIFESPHERE®

Checklist: Essential Features of a Future-Proof Automated eTMF System

Don’t let insufficient Trial Master File tools hold your team back

Managing the Trial Master File (TMF) is one of the most critical and challenging aspects of running a successful clinical trial. If your organization is relying on legacy tools or homegrown processes — there are modern and reliable solutions to ensure the TMF meets regulatory standards.

As you evaluate a new solution, this checklist can be used to ensure the one you choose has the essential functions and capabilities you need to deliver comprehensive and compliant TMFs – now and into the future.

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
LifeSphere Clinical eTMF Submission Checklist

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.

LifeSphere Clinical eTMF Dashboard
LifeSphere Clinical

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