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Complete Clinical Trial Monitoring in One Unified Solution

Agile monitoring models that enhance your data and patient safety

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The traditional method for monitoring clinical trial activity has leaned heavily on in-person site visits, manual source data validation (SDV), and dispersed systems that delay data visualization. LifeSphere Clinical is challenging the traditional method with intelligent monitoring that offers real-time, comprehensive views into critical patient and site data. Conduct clinical trial monitoring across multiple sites and regions with ease. All while knowing that you’re accessing the latest view of your protected data while remaining globally compliant.

What is the purpose of Clinical Trial Monitoring according to regulators?

Clinical trial monitoring is critical. It ensures that the rights and safety of clinical trial patients are protected and also ensures clinical data for research is conducted in compliance within regulation.

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Guideline for Good Clinical Practice established and continue to maintain guidance surrounding the ethical practice of clinical trial monitoring.

According to the ICH guidance, the purpose of clinical trial monitoring is to:

  • Verify the subjects’ rights and well-being are protected throughout the course of the study.
  • Ensure that all trial data is accurate, complete, and verifiable against source documents.
  • Operate the trial in accordance with the currently approved protocol.

As organizations scale their clinical research or as new regulations are introduced, it can become increasingly difficult to conduct clinical monitoring in accordance with ICH guidance without the right technology to support. As clinical trials globally grow in complexity, more life science organizations are turning to innovative technology purpose-built for the industry to navigate seamless site monitoring and document navigation.

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LifeSphere eTMF is the first industry system to support both the TMF Reference Model and the eTMF Exchange Mechanism Standard which provides Clinical operations with everything they need to streamline trial oversight and documentation.
Clinical Product Suite Choosing the best platform for your clinical trial needs is essential to setting your organization up for success. That’s why LifeSphere CTMS is built differently from other platforms with your organization in mind, providing the best, complete solution to meet your Clinical needs. LifeSphere Safety Document Distribution is the clear solution for your SUSAR reporting needs and more. By enabling you to have reports distributed as needed and paired with cover letters in the language you specify, you’ll enjoy a streamlined and simplified global document distribution process. In the development lifecycle, documentation seems endless. Bring your data and documentation together in an easy-to-use, cloud based solution designed specifically for life sciences organizations. Your team needs support beyond just another digital file system, and LifeSphere EasyDocs can help you to.

How LifeSphere Clinical enables teams to fulfill the purpose of clinical trial monitoring

Without a holistic view of clinical trial activity, how can organizations ensure the rights of their subjects are protected, their trial reported data is accurate and complete, and that the trial is conducted in compliance with protocol, Good Clinical Practice (GCP), and other regulatory requirements?

LifeSphere Clinical was built by industry innovators to deliver better oversight and collaboration on critical trial documents while helping you maintain patient safety and compliance.

LifeSphere Clinical enables better clinical trial monitoring by:

  • Replacing on-site activities with remote monitoring workflows reducing the need for travel and lowering your overall monitoring costs.
  • Connecting your clinical ecosystem through LifeSphere Clinical to enable faster data sharing from theInvestigator Site File (ISF)to theTrial Master File (TMF)andClinical Trial Management System (CTMS).
  • Digitally enabling site monitors to review more sites at once and conduct faster overall reviews with remote dashboards and collaborative data sharing.
  • Reducing manual data entry or risk of human-error through automated workflows and error reporting.
  • Providing Clinical Operations teams with confidencethat all LifeSphere Clinical products are compliant with present and future regulatory standards.

LifeSphere Clinical’s Trial Monitoring Ecosystem

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LifeSphere CTMS

A complete solution for your study start-up, payments, and advanced site monitoring that has been proven to expedite site monitoring trip reports by 30%

LifeSphere Safety Document Distribution

LifeSphere Safety Document Distribution

Monitor and manage global compliance from a centralized report distribution system.

etmf dashboard

LifeSphere eTMF

Align your clinical documentation with regulation and study protocols to manage and maintain a single source of truth for your clinical research.

Having a production-ready unified suite of clinical solutions unlocks unprecedented synergy and efficiencies within your clinical research. Having a single source of trial data creates a powerful repository that not only aids in generating faster investigational or site monitoring reports, it also provides deeper data-driven insights.

Learn more about the benefits of a connected clinical ecosystem

Discover the Benefits of LifeSphere Clinical for your Clinical Trial Monitoring

Streamline Site Operations

Optimize your site monitoring and payments with remote workflows that replace the need for on-site visits and increase your data accessibility and accuracy

Unify Your Study Management

Connect your monitoring efforts to your larger clinical ecosystem with LifeSphere Clinical’s unified, natively interoperable solutions.

Accelerate Your Trials

With a solution crafted for clinical teams, you can automate operations and streamline data sharing across dispersed teams to decrease the risk of human error, increase data accuracy, and achieve study milestones sooner.

Enhance Clinical Collaboration

Connect your sponsors, CROs, site, and study management teams on a single solution that offers role-based access and live data sharing optimal collaboration

Clinical Trial Monitoring dashboard

Comprehensive features for flexible study oversight:

  • Seamless data sharing on a cross-platform, cloud-based application.
  • Advanced site monitoring workflows including flexible site payments and study start-up in one solution.
  • Automation workflow purpose-built to detect data discrepancies, manage risk, and reduce human error.

Seeing is believing
See LifeSphere CTMS in Action

LifeSphere Clinical was built by industry leaders to combat the rising complexity and costs associated with traditional clinical trial management and monitoring. Our solutions have helped sponsors, CROs, and life science organizations harness the power of a connected clinical ecosystem to optimize their trial monitoring efforts. Improve interactions with your investigation and research sites while improving the visibility and accuracy of your clinical trial data.

LifeSphere Clinical

LifeSphere Clinical was built by industry leaders to combat the rising complexity and costs associated with traditional clinical trial management and monitoring. Our solutions have helped sponsors, CROs, and life science organizations harness the power of a connected clinical ecosystem to optimize their trial monitoring efforts. Improve interactions with your investigation and research sites while improving the visibility and accuracy of your clinical trial data.

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Read about life science companies making the leap – and benefit from – moving to a unified clinical ecosystem

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Leading Clinical Research Organization Selects LifeSphere Safety Document Distribution

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