ClinSpark version 1.4 Released
Press Release: Foundry Health releases version 1.4 of ClinSpark, the eSource platform for Phase I automation
Grafton, WI March 11, 2019 – Foundry Health is proud to announce the release of version 1.4 of its Phase I software platform ClinSpark®. This new version contains many significant improvements over its already feature-rich predecessor. Major improvements have been made in the areas of Study Subject management, ECG review and Informed Consent procedures. Connectivity enhancements have been made benefiting safety lab interfaces and a connection has been established with Verified Clinical Trials to check for potential duplicate subject enrollments.
In version 1.4, subject status monitoring has been greatly enhanced through a dedicated section under study conduct. Built with physicians in mind, it allows for actionable management of Subject Status, Adverse Events (AEs), Assessments, Eligibility, Informed Consent, Over-Volunteering, Subject Details and Audits. The feature also supports a flexible dashboard mechanism similarly seen in other areas of ClinSpark®.
ClinSpark® now allows for a detailed level of ECG review, typically only seen with ECG core labs. Through a built-in connection to the world-renowned CalECG software from AMPS, investigators can analyze and annotate ECGs, overlay multiple ECGs to look for trends, or change automatically placed calipers for a more accurate manually adjusted assessment of key ECG parameters. The ECG module works with the hardware of all major ECG vendors.
Volunteer safety and GCP compliance are improved by a robust process for assessing study subject eligibility. A sophisticated barcoded, version-controlled Informed Consent procedure ensures that study procedures can only proceed if the valid version of the ICF has been signed. Deep insight into a subject’s status against eligibility criteria supports enriched review by the investigator to support better decision making. Invoking verification against the Verified Clinical Trials database from within ClinSpark® ensures enhanced security against duplicate enrollment.
Brock Heinz, CEO of Foundry Health stated: “With version 1.4, our clients have even more powerful features to further support the world’s most demanding users, and difficult trials. Our modern, cloud-based technology is a tremendous asset in the fast development of new functionality. We’ve included a long list of technical and process enhancements, and made ClinSpark® even easier to implement and use. The connectivity potential of our platform is unique in the industry, which allows us to bring the world’s most sophisticated technology into the hands of our clients’ clinic staff. So whether our customers are running PK-studies, complex first-in-man trials, or large Thorough-QT trials, ClinSpark® is a natural fit.”
ClinSpark® enjoys a rapidly growing user base. The feedback and needs of users is of crucial importance and there is a direct dialogue between them and the ClinSpark® development team. The agile development approach ensures fast and effective solutions built into a continuously improving product. The enhancements seen in version 1.4 are therefore of real practical benefit to Phase I units.
To accompany the release of version 1.4, a new website is launched – www.clinspark.com. The site contains details of unique ClinSpark® features, shows the software in action, and details pricing information. The blog section gives access to in-depth product highlights, development announcements, and news.
About Foundry Health
Foundry Health is the company behind ClinSpark® (www.clinspark.com), the eSource platform for Phase I automation. Its modern infrastructure allows for easy connection to clinical devices, labs, databases and data review tools of all sorts. The CDISC ODM certified data structure ensures compliance with all regulatory and data standards. The modern ‘mobile-first’ user interface and fast barcode enhanced navigation, make the system easy to use and contributes to the highest user experience ratings in the industry. ClinSpark® is offered as a SaaS (Software as a Service) solution with no long-term commitments, and a competitive ‘pay-per-use’ pricing structure. Being hosted on the world’s most advanced cloud-infrastructures, ClinSpark® allows for infinite global scaling without performance degradation. For more information, visit www.clinspark.com or www.foundryhealth.com.