ThoughtSphere 1.12 Release Notes

We are stoked to announce several new features and functionalities within our modular platform to continue to push the needle and advance clinical trial operations.

New Features:

ICH E8 R1 Compliance

The integration of ICH E8 R1 requirements into the platform to capture Critical to Quality (CtQ) Factors and trace their path throughout the study from risk mitigation through data review and tracking activities to ensure project teams are focusing on errors that matter.

Clean Patient Tracker

Going hand-in-hand with the ability to monitor CtQ Factors is the introduction of our all-new Clinical Patient Tracker (CPT) Module. This module automates the tracking of data collection & review tasks at the patient level to support Database Lock, interim analyses, data snapshots, and batch cleaning plans. A key feature of the CPT that you’ll love is the comprehensive dashboard that allows you to quickly see and drill down into trends by site, review type, and CtQ Factor.

Auto Query to EDC

You asked and we answered! Our data management capabilities have been expanded to offer auto-query write back to EDC. Now users can automate the data validation process from data check creation to query generation using the platform’s AI-enabled Smart Check engine and query write back functionality. By simply turning on the auto query function, whenever a data check’s conditions are met, a query will be generated and written back to the EDC for the site to address.

Incremental Listing Review

We have also added incremental listing review functionality to save end-users valuable time and energy reviewing lengthy listings and/or manually tracking data changes between listing review cycles. Using the platform’s digital workflows, the system deciphers new and changed data since the last review cycle and highlights this data to the end-user so they can target their review accordingly and not spend hours combing through data that hasn’t changed.

Biostatistics & Programming

Another big-ticket item included in this release is new functionality in our Biostatistics and Programming offering. The platform now supports the creation of analysis and tabulation datasets, including an ADaM dataset generation and approval workflow. Our controlled terminology library provides an exhaustive list of currently published terms that can be applied to a Study level ADaM dataset or users can create study specific controlled terminology and associate it with ADaM variables.

Outbound Data Framework

And last but not least, the platform now offers an outbound data framework to expedite data exports and integrations. Users can extract raw, transformed or aggregated data at the subject, site, study, or program level to support interim analyses or other data deliverables. The data can be delivered through an SFTP data dump or extracted through an API call to integrate data with other systems, automate data archiving, and provide timely data to external stakeholders with ease.

Updates & Enhancements

We have also updated and enhanced many of our existing features, that might not make the headlines, but provide real value to our customers, including:

• BI Tool UI upgrades for enhanced user experience
• Data snapshot capabilities and the ability to track data changes by version
• Smart Map metrics to monitor mapping efficiency gains

Want to learn more?

To all our existing customers, let’s talk about next steps to updating your platform version so you can capitalize on all the new features and capabilities! Please reach out directly to your customer support lead or contact us at support@thoughtsphere.com.
To non-existing customers that want to learn more about our latest release and see a product demo, reach out to our sales team at sales@thoughtsphere.com. We look forward to connecting with you!