niAnalytics™ is a next generation EDC software that has been developed directly in relation to client needs, providing added-value with its high degree of customization while increasing clinical trial efficiency and effectiveness.
It is an integrated SaaS solution, built to be as flexible as technology allows facilitating the customization of the system to client workflows without additional programming needs. This approach also ensures that mid-trial changes can be implemented easily.
Due to its built-in flexibility, niAnalytics™ is designated for all types of studies and different types of organizations, regardless of their size.
The following enablers allow for key customization:
- Unlike other systems, niAnalytics™ facilitates the clinical study process right from the beginning. The software enables users to carry out study planning tasks as e.g. writing the clinical trial protocol.
- This planning capability is assisted by a unique document management module which allows defined user groups to work on shared documents including versioning and approval workflows. Hence, study planning and other activities, traditionally derived by an expert team, are now supported by niAnalytics™. The system supports all types of documents. For example, the user can create documents from third party software such as word, pdf or excel, and can upload any of these into the system where other, authorized users can collaborate.
- When creating the clinical trial protocol using the designated elements the system automatically translates them into CRF objects.
- Current EDC systems only enable patient data collection through electronic Case Report Forms (eCRF). Although most important and complex, eCRFs only represent one data collection tool for prospective trials. With niAnalytics™ any kind of document or tool for data collection can be created. It empowers the user to create a whole set of Visit Report Forms (screening, initiation, regular, close-out) with powerful edit checks, data controls, alerts and queries. Hence, Patient Reported Outcome (PRO) instruments or any other workflow or clinical document for data collection can be used.
- With the unique user manager, authorizations can be defined in the desired granularity level. Together with the study organization module, the sponsor can define structures, workflows and authorizations.
The inclusion of planning activities into the application scope, remote collaboration, automated CRF creation and other features reduce planning and set-up time and cost considerably. In addition, all documentation related to one particular study can be stored centrally within that instance of our software.
Moreover, niAnalytics ™ supports the application of multiple trials on a single instance of the system (MTSI). Users can have different roles and rights across multiple trials. As a consequence, all trial-related documents are stored in one place. Combined with the document and object library that is available across all trials within the portfolio, this can become a powerful tool as well as all study document types and data collection instruments (objects) can be predefined or reused while being editable at all times. The availability and access to these templates can be managed on individual, trial or organizational level. This allows any organization with more than one trial to realize efficiency gains by re-using previously employed objects. MTSI capabilities (including libraries) are CROs, academic centers or cooperative groups.
NiAnalytics ™ enables the user to define basic clinical trial protocol elements through its graphical user interface.
The integrated planning module supports the user to create a timeline. The timeline tracks of patient visits, encounters, interventions or examinations during the trial period and is by one simple click exported to the trial calendar. Alerts and notifications help clinical trials professionals cope with the scheduled tasks. After inclusion of each patient, all important dates, visits, interventions or examinations are included in the schedule.
To top the planning process, the protocol is an integrated part of the EDC design system and the user can create basic eCRF structures directly from the protocol and the patient timeline.
NiAnalytics ™ is applied to all types of studies, independent of their size.
niAnalytics™ contains further modules, tools and features that ease the lives of clinical specialists and increase efficiency and effectiveness:
- The intuitive, drag-and-drop based trial set-up without programming needs shortens the time to market and helps saving cost.
- While we provide a standardized solution (CTCAE v4), the automated coding of adverse events enables the user to incorporate their own logic.
- Our system contains a real-time alert for adverse events to ensure prompt risk mitigation.
- Queries for any type of document can be tracked, managed and resolved through the intuitive user interface.
- niAnalytics™ comprises two independent software modules that support sample size calculation and randomization. Hence, the user can calculate the required sample size and randomize the study population into study groups. However the sample size calculator may also be used in case of interim analysis in order to evaluate the power or size effect for an event of interest.
- All collected data with its complete history is available for export at any time for further statistical analysis.
- The study metrics functionality helps you derive insights about your study and the allocation of time to different process steps.
- The system enables the integration of multiple languages (right-to-left as well as left-to-right) with adjustability at user level. This enables usability of the software for global studies.