ClinSpark Version 1.5.0 Released

October 15, 2020| | in category Development Announcement Comments Off on ClinSpark Version 1.5.0 Released

The Foundry Health team is excited to announce the latest release of ClinSpark, the world’s first CDISC ODM certified Phase I eSource and clinical trial automation system. Version 1.5.0 contains new functionality and improvements over its already feature-rich predecessor. Much of the development focus was based on Foundry Health’s product vision and shaped by ongoing customer feedback.

Improvements have been made focusing on ECG management, label design management, samples processing, volunteer management, study recruitment, and the Verified Clinical Trials interface.

ClinSpark now supports remote volunteer device monitoring capabilities. As the industry continues to see a rising trend in remote trials, more and more data is collected from study subjects when they’re not in the clinic. Wearable and mobile devices are ideal to capture such data with minimal effect on the subjects daily activities. ClinSpark version 1.5.0 introduces support for wearable and mobile devices associated with volunteers. Remote volunteer devices can be managed and connected to volunteer records, and the device data can be monitored directly via ClinSpark.

Connected device data can be reviewed in the Volunteer Monitoring module.
Connected device data can be reviewed in the Volunteer Monitoring module.

New ECG functionality now meets the ICH E14 guidelines for TQT trials. Sites can facilitate ECG workflows in TQT trials for cardiologist review in order to perform inter and intra reader variability (IIRV) measurements. Previously established ECG capabilities, used for study assessments intended for PI safety review, remain in place and accessible within the Subject component. 

The new ECG > Manage component provides insight to and management of ECGs collected in a study intended for cardiologists participating in inter/intra reader variability (IIRV) measures.
The new ECG > Manage component provides insight to and management of ECGs collected in a study intended for cardiologists participating in inter/intra reader variability (IIRV) measures.

A new Barcode Printing feature now supports the ability for sites to manage their own ClinSpark label designs. Using the Zebra Designer 3 software and configurable merge tags supported by the Foundry Health team, sites can now design and import their own labels templates for use. Barcode verification workflows also ensure that all designs imported are able to be successfully printed and scanned through ClinSpark.

The new Barcode Printing > Manage component provides users the ability to import and manage their own label template designs into ClinSpark for use across the application.
The new Barcode Printing > Manage component provides users the ability to import and manage their own label template designs into ClinSpark for use across the application.

Several enhancements supporting evolving lab requirements and intense sample processing pathway designs have also been included. The Samples > Configure component has been enhanced with a new interface to support a variety of complex pathway requirements. The interface shows configured pathways through a branching hierarchy to help visualize the relationships between various tasks. Sites can also now setup pathways with divergent paths, multiple specimen containers, and the ability to pool and separate aliquots.

A new interface in Samples > Configure now further assists users in designing and reviewing complex sample path configurations.
A new interface in Samples > Configure now further assists users in designing and reviewing complex sample path configurations.

ClinSpark also now supports a new interface with eConsent vendors, supporting study specific ICF workflows. Sites can now setup study ICF requirements to obtain consent information from eConsent vendors such as Medidata. Users can review and approve inbound consent requests.

A new component for Volunteers> eConsent supports the management of study specific consent requests coming from an external vendor.
A new component for Volunteers> eConsent supports the management of study specific consent requests coming from an external vendor.

Enhancements were also made across various components in order to better serve organizations using a single instance of ClinSpark to cover volunteer management, recruitment, and study participation in multiple geographical locations. Due to the distributed nature of recruitment teams and study volunteers geographically, we adopted changes to better support regional privacy laws, systems of measurement, and territorial entities impacting things like physical address/locations, phone numbers, and volunteer demographics.

A new feature supports the ability for users to acknowledge a customizable enrollment confirmation statement for new volunteers added to the database. This is an optional site setting.
A new feature supports the ability for users to acknowledge a customizable enrollment confirmation statement for new volunteers added to the database. This is an optional site setting.

There are many more exciting enhancements in version 1.5.0, driven by valuable customer input. Customers will have access to the full set of release notes and technical file artifacts through our official support channels.

Since our last release, ClinSpark has seen a rapidly growing user base. Listening to ongoing customer feedback and understanding the needs of users is of crucial importance to our development team. Our development and release approach continues to ensures fast and effective solutions built into a continuously improving product.

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