ICT Innovation in Clinical Trials

 

ICT Innovation in Clinical Trials GmbH ("ICT") is a limited liability company based in Vienna, Austria. ICT was founded in September 2015 as a spin-off of J&P MEDICAL RESEARCH LTD. ("JPMR"), a research institute with many years of experience in designing, managing, and monitoring clinical trials on an international level. ICT combines an interdisciplinary team of professionals (former JPMR staff members) in the fields of medical research, international management, economics and IT.

 

Since June 2016, ICT and JPMR have been joining forces to develop a novel tablet-based IT solution that will digitalize the informed consent process in clinical trials. With patient centricity as its core element, this solution, called premierConsent®, aims at providing full transparency and optimized patient education during the entire consenting process.

 

Based on innovative tablet technology, premierConsent® will - for the first time - combine patient education using custom-tailored multimedia content on the one hand and informed consent process capturing using audiovisual recordings on the other hand. At the same time, premierConsent® will serve as a clinical trial information hub for several stakeholders involved, such as clinical monitors, institutional review boards, ethics commissions, regulatory authorities, and trial sponsors, with varying levels of access and information detail depending on applicable regulations.

 

Additionally, premierConsent® will harmonize the delivery of essential information on risks and benefits of a clinical trial across all trial centers. It will also offer a long-needed opportunity for underprivileged patient populations, such as minors, elderly, poorly educated or illiterate people, to intuitively understand the activities involved in clinical trials.

 

Ensuring the highest standards of patient safety and privacy as well as data protection and security has been a prerequisite for the development of premierConsent® from the very beginning on. Additionally, premierConsent® will eliminate the need for paper documents and thereby significantly impact and enhance clinical trial safety, data reliability, regulatory compliance and cost efficiency.

 

For operational and strategic purposes, JPMR was entrusted with developing and marketing premierConsent® by way of a license agreement as of June 2016. Since then, JPMR's team is in charge of product and software development as well as financial operations. Not being tied up in day-to-day operational tasks, ICT's management team can therefore focus on long-term planning, establishing investor relations and building strategic alliances and partnerships for introducing and expanding premierConsent® on the market for clinical trials.