Projects

Open Source Clinical Application Projects

Coming Soon! Clin.Net is proud to announce the availability of a range of applications, technology, services and de-identified clinical data sources for clinical R&D and AI

Electronic Trial Master File App

SureETMF is an Electronic Trial Master File (eTMF) content management application for clinical trials under Clin.Net’s free open source projects. SureETMF utilizes a flexible standards-based classification model, and can support any content classification model, such as the OASIS ETMF Standard or the TMF Reference Model. Built on web standards, SureETMF supports knowledge graph technologies used in AI applications. This app is scheduled as a new Clin.net project for Q3 2024. SterlingBio is the contributing corporate sponsor. SterlingBio is contributing the app to Clin.Net under the Apache 2.0 open source license. SureETMF has been used by major CROs, sponsors and medical device companies on over 500 clinical trials and has passed multiple FDA audits. FDA, EU and ISO compliance validated versions available separately.

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Electronic Investigator Site File App

SureEISF is an Electronic Investigator Site File (ISF) content management application for Investigator Sites under Clin.Net’s free open source projects. SureEISF utilizes a flexible standards-based classification model, and can support any content classification model, such as the OASIS ETMF Standard or the TMF Reference Model. Built on web standards, SureEISF supports knowledge graph technologies used in AI applications. This app is scheduled as a new Clin.net project for Q3 2024. SterlingBio is contributing corporate sponsor. SterlingBio is contributing the app to Clin.Net under the Apache 2.0 open source license. SureEISF has been used by major CROs, sponsors and medical device companies on over 500 clinical trials and has passed multiple FDA audits. FDA, EU and ISO compliance validated version available separately.

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Quality Management System App

SureQMS DocTrain and SureQMS Events are modules in a Quality Management System (QMS) application for biopharma and healthcare. SureQMS utilizes a flexible web standards-based classification model, and can support any quality reference model. Built on web standards, SureQMS supports knowledge graph technologies used in AI applications. This app is scheduled as a new Clin.net project for Q3 2024. SterlingBio is contributing corporate sponsor. SterlingBio is contributing the app to Clin.Net under the Apache 2.0 open source license. SureQMS has been used by SureClinical for hundreds of sponsors and medical device companies globally. SureQMS has independent compliance validation certified by USDM (2024) for FDA Part 11, EU, ISO-9000, SOC1, SOC2, SOC3 and many more certifications. Compliance validated version available separately.

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