This major release 2.0.0 comes with main changes to our system structure, improved and entirely new features, as listed below.
Changes & improvements:
- The patients, (S)AE and samples module, previously modules on instance level, have been moved underneath a study, now presenting sub-modules of a study. Thus, all study relevant events and information are linked to its respective subject within a study.
- Collaborator rights access (sites, roles, management rights) and input form set-up, previously on instance level, can now be managed within a project (study or survey).
- User rights are now configurable on a more granular basis, differentiating between main users (instance rights) and collaborators (users with project access). In addition, distinguishing between site rights (i.e. subject-specific rights) and management rights (i.e. project configuration rights) within a project is now possible.
- The new audit trail layout for the subject audit trail per project will make it easier for users to view and filter for the information needed.
- Navigation and project set-up flow are adapted based on the new structure, (sub-)modules activated and customized project configurations. These changes, also referred to as the Isolated Project Cosmos (IPC), will enable our customers to manage multiple projects with different partners within the same instance and at the same time.
- The progression widget allows users to see the development of a subject's data points (e.g. lab parameter) captured over time (e.g. across multiple study visits).
- The benchmarking widget helps to compare a defined data point of a subject to the values of the study's subject population. Benchmarking can be performed for one specific point in time as well as for the entire or filtered study population.
- A new field type, the smart field, performs automatic real-time processing and calculation of a subject’s data based on a configurable syntax logic.
- Export of collaborators per study including assigned site and management roles.
- Configurable enrolment screen per study.
- And many more!
- This update contains multiple fixes in all areas mentioned above, please find all details in the release notes.
You can view and download the release notes for the 2.0.0 version update here.