Platform Description
TrialKit is a platform of interconnected applications running from a common web service hosted on secure dedicated web servers. The platform allows users to configure databases for their own unique data collection requirements, and then deploy the database to their own managed users for inputting the targeted data. Development of the platform, and its functional requirements are authored and conducted under health sciences industry-specific regulatory guidelines for clinical research data.
This knowledge base can be used to find any information regarding functionality, compliance, and security.
What is each version of TrialKit and what makes them different
As a cloud based platform, all users are kept on the same latest version. For auditing purposes, it might be necessary to track changes over a long period of time for studies that are conducted over that period.
The version certificate available in the trust portal has the details of this information, but below is a summary of why each new major version was released. In between each of these major versions are several minor versions containing dozens of new features and enhancements.
v4 (2019) - First formalized validation performed under established SDLC process.
v5 (2020) - Data model changes were introduced that raised the risk of change and required a full re-validation of the platform. Impact was ultimately rated low.
v6 (2021)- The Quality department triggered the requirement for full platform re-validation based on several changes made in the SDLC process
v7 (2023) - New framework of web forms was introduced. This is considered a major change requiring full re-validation. The use of this new function was not forced to be used on existing studies, so the impact remained low.