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 EDC platform is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs 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 several 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.
LOW CODE PLATFORM
We follow the design principal of low code platforms where we allow business users and subject matter experts to create an entire research platform without writing one line of code.
All the edit check and derived calculations are created via the front-end using one of our GUI creation tools.
Our platform allows studies to be configured using existing libraries of questions and procedures (pre-coded with SDTM naming standards). Putting generic procedures together is done within minutes as most of the derived calculations and edit checks also form part of the pre-configured library.
Study specific data points and procedures are created using several tools which allows for everything to be done via the front-end using a single resource.
We approached reporting in the same way we approached rapid configuration of studies. Our comprehensive reporting tools allow all stakeholders within the clinical research life cycle (Sponsors, Project Managers, Clinical Research Associates, Data Managers, Safety Physicians, etc) to build and export reports based on their interest.
This also feeds into our fully customized dashboards feature which is linked to each personal profile within the study.
ePRO / eCOA
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)
VISIT SCHEDULE WIZARD
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.
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.
INTEGRATED INTERACTIVE RESPONSE TECHNOLOGY (IRT)
The randomization schedule is generated by the statistical team using a program like R/SAS, which is then imported directly into the IRT module of Nukleus. The stratification criteria can then be configured within Nukleus.
The IRT module includes the following functionality:
Allocation of replacement IP
Re-ordering of IP
2-tiered authentication when receiving IP at site
Automated notifications related to successful randomization
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.
Medical records are rapidly migrating away from paper files to electronic records. Our Nukleus solution has the ability to extract data directly from the eSource platform, removing the burden of transcription from the site. This method reduces the need for Source Data Verification (SDV) and also empowers a more sophisticated form of centralized monitoring.
INTEGRATED MEDDRA MEDICAL CODING
Our Nukleus EDC platform allows for different coding libraries (ie. MedDRA, MIMS, ICD 10) to be used to either help code the concomitant medication, medical history or adverse event terms
These coding libraries are fully integrated and can be included in any of our solutions should the sponsor company, CRO or research facility be licensed to do so.
The coding is configurable and allows the user to use either the verbatim term, lower level term or preferred term as their primary point to data capture.