Complete Clinical Trial Monitoring in One Unified Solution

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.

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.

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 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.