Nukleus is our Electronic Data Capture (EDC) platform built for the emerging market, making use of first world technologies. The web-based platform can be accessed from any device.
Our system is designed for the collection of clinical trial data in electronic format for use mainly in clinical trails.
EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drug and medical devices.
Our solution allows the customer to configure their solution entirely through the front-end. The configuration includes role based access, edit check validators, skip/add logic, derived calculations and more.
The structure of the platform follows the idea of a patient/subject file, where each file contains a number of different folders (which can represent a patient/subject visit) with a number of different forms/procedures inside. Each of the forms/procedures contains one or more questions/data-points which is captured against the specific subject.
Electronic Patient Reported Outcomes (ePRO) is a method that allows patients to complete questionnaires. Our platform allows for this to be done in the form of web-based surveys, two-way text message communication or USSD (Unstructured Service Supplementary Data)
With a click of a button, the system will allow you to make a PDF backup of ALL the information for a participant. This is useful if you want to build a library of information of your own and you want the participant information in a nice neat package.
The tool allows the user to select the layout and format of the print out.
The tool is available on a global overview of the entire case profile, per Visit or per Procedure level.
VISIT SCHEDULE WIZARD
The visit scheduler component within Nukleus takes the schedule of events (as defined within the protocol) into account and calculates the different visit dates per participant.
The window periods are defined upfront and are automatically linked to edit check validators which will warn the investigator if a visit is overdue (out of window) or missed.
OFFLINE (Launching Beta Release in Dec 2019)
Offline capability is useful when you want to use an EDC system in an area where network connectivity is poor (for instance, rural locations) or where you want users to be able to work disconnected from the network. Some of our platforms support this and stores all data until network connectivity is available and data can be synced.
This feature relates to the automated creation of documents in Portable Document Format (PDF) for submission to CDER (Center for Drug Evaluation and Research) or CBER (Center for Biologics Evaluation and Research), that align with ICH M2 recommendations and that are in a format that the receiving Center (FDA) currently supports.
FDA APPROVED SUBJECT EXPORTS
INTERACTIVE RESPONSE TECHNOLOGY
The Interactive Response Technology (IRT) module within Nukleus includes the following features:
Importing randomization schedules generated from SAS or any other statistical software,
Applying rules based on stratification criteria.
Shipping and allocation of IP to specific sites,
Allowing for replacement of IP,
Generating the randomization number for enrolled participants in real time based on stratification variables.