Removing the paper element in clinical research
We have a leadership & development team with more than 100 years of combined experience in drug & software development. We make use of the latest technologies to ensure that our development platforms are current and relevant to the industry changes. Although we abide by the strict rules set out by the FDA on developing applications storing sensitive information, we are forward thinking in our processes and venture to produce market relevant and user-friendly systems.
Our Nukleus(R) Suite revolves around the core module being an Electronic Data Capture (EDC) system, which is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. An EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and clinical research organizations (CRO).
UNIQUE PRODUCT SOLUTIONS
Keeping track of patient and study related income and expenses is made easy using our finance module with Nukleus Product Suite.
Making contact with patients or participants in a clinical based in rural settlements are made easy using our emerging market mobile technologies.
A fully integrated participant and investigator scheduler module is part of the Nukleus EDC and EMR product – this improves diary management.
Entire clinical trials are setup through the front-end making use of data point and edit check wizards. A centralized library of common data points and edit checks are shipped with every install.
Standardized reports are shipped with each of our solutions and include a number of modules where customized reports can be generated and exported to a file type of your choice.
Creating regulatory documents (formal letters, personalized reports, etc) takes up a lot of time – our letter generator module makes this very easy using customized letterheads and footers for each customer.
Our solution stack allows for a number of integration methods to be used – ranging from import/export to web service calls using APIs.
Our solution stack was built in the beginning with customization in mind. The unique platform framework allows customers to design their own solution within days using our setup wizards.
All of our solutions are cloud hosted within SOC-3 certified data centers across the globe. We have certified Amazon Web Services partners and make use of AWS hosting facilities where possible.
LATEST NEWS & RESOURCES
We are delighted to share the following significant changes and positive developments which took place recently within the TCD Group. New Ownership EOH, a JSE-listed South African based Knowledge Management group, have been in negotiation with the TCD Group since the last quarter of 2015, sharing the strategic objective to expand in the field of […]
“A lot has happened in the clinical trials industry in 2016, as biopharmaceutical enterprises are just starting to delve into clinical trial innovation. Risk Based Monitoring (RBM) is starting to expand into new concepts in Quality Risk Management; enterprises have aggregated their data to generate clinical trial predictive models; the definition of patient centricity is […]
For most people the concept of three-dimensional (3D) printing is still seen as something from a science fiction novel, but the medical world is busy embracing this technology and is a major driving force behind its growth. Dr Thomas Bartel, section head of the Heart and Vascular Institute at Cleveland Clinic Abu Dhabi said the following […]
“In the last six months, we’ve gathered more than 10 billion sensor measurements from more than 100,000 contributors. Of course, raw sensor data is not a biomarker, a biomarker is not a diagnosis, and a diagnosis is not a therapeutic,” co-founder of Cardiogram Brandon Ballinger wrote in a blog post. “This volume of data has let us […]
mHealth (mobile Health) is more and more becoming the standard when it comes to Patient Reported Outcomes (ePRO) or patient engagement in the discipline of pharmacovigilance. According to the Center for Connected Health Policy, remote patient monitoring is the use of “digital technologies to collect medical and other forms of health data from individuals in […]
The Microsoft corporation is assisting the oncology team at the Australian National University (ANU) to uncover more about the genomics of cancer. This process will help identify which genes have been affected in a negative way in the genome. “The collaboration between biologists and computer scientists is actually key to making this work,” Microsoft’s corporate vice-president Jeannette Wing […]
The growth of the digital healthcare market has been steady over the past 10 years but in recent times this growth curve has changed exponentially. The introduction and adoption of mobile applications and wearable devices related to wellness and healthcare have been one of the main drivers behind this. “Mobile network operators view mHealth as […]
TransCelerate BioPharma Inc.(“TransCelerate”) is a non-profit organisation dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies.The Clinical Data Interchange Standards Consortium (CDISC) is a 501(c)(3) global non-profit charitable organisation that streamlines research and enables connections to healthcare through the development of clinical […]
GlaxoSmithKline (GSK) has been on the forefront of research innovation and this is no exception. By using Apple’s ResearchKit, London-based GSK are aiming to reduce research costs and improve overall efficiency in terms of data accuracy and patient recruitment. Phase IV observational trials, such as this one, can take months or even years to recruit and enroll patients, […]
Freestyle Libre, that is the name of the new wearable glucose monitor created by Abbott. They shared the results of their clinical trial at this year’s annual meeting of the American Diabetes Association. Some of the results include that wearers of the device spent 38% less time in hypoglycemia compared to patients that still need […]