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Highly informative early-phase studies will minimize risks and reduce costs
Fort Lauderdale, FL - Enhanced patient safety and improvements in the delivery of healthcare are the twin forces behind an innovative, technology-driven think tank newly launched by OmniComm Systems, Inc., a leading provider of clinical data management technology, and the Centre for Human Drug Research (CHDR), one of the largest and most-established, early-phase drug development organizations in Europe.
CHDR and OmniComm will collaborate in a new technology evaluation center in Leiden, the Netherlands, where innovative products and electronic data capture (EDC) management systems will be immediately tested in an onsite clinical setting. Through this unique collaboration, both organizations will create and launch a broad portfolio of devices and EDC processes that will ultimately help the life sciences industry develop medical therapies to improve the quality of healthcare services around the globe.
In the near-term, the collaboration is expected to yield a revolutionary mobile app for patient-reported outcomes. This technology will enable participants in clinical trials to directly report or transmit related healthcare data into a trial’s database. In the EDC industry, the planned mobile app - by enabling patients to self-report - represents a major step in the emerging E-source trend in clinical trials. With an emphasis on ease-of-use, efficiency and accuracy, this mobile app is being designed to give researchers additional tools for testing the safety and effectiveness of medical therapies during clinical trials. The revolutionary app for direct patient reporting of outcomes is expected to be tested by subjects in a large trial in patients with a psychiatry indication during the first half of 2017.
Additional products in the pipeline include a platform for the integration of data from wearable sensors, thereby allowing patients to directly report a large part of the research on new medicines and devices in the comfort of their home, using the CHDR Trial@Home methodology. Trial@Home aims to perform highly informative, data-intensive studies under naturalistic conditions in the comfort of the subject’s home, office or any other environment beyond the standard clinical research unit.
“Such collaboration between a clinical data capture and management technology provider and a CRO is unique and provides immediate feedback on the utility of OmniComm’s products,” said Cornelis Wit, CEO of OmniComm Systems. “We are pleased to be partnering and working with such a world-class organization.”
“There is a lot of technology for performing measurements in patients,” said Adam Cohen, CEO of CHDR. “But many of the existing products are not yet sufficiently integrated into the general data management of trials and are often not well-validated or reliable. In this collaboration, we will produce products and services that are both innovative and exciting, with the robustness and quality required in a strict regulatory environment.”
Senior leaders from both organizations express admiration of the collaboration and view the joint evaluation center as a partnership that unites OmniComm’s technological expertise and experience in the EDC industry with CHDR’s depth of experience in the healthcare industry.
About the Centre for Human Drug Research (CHDR)
Centre for Human Drug Research (www.chdr.nl) provides a full range of early-stage clinical pharmacology services. CHDR specializes in early proof of pharmacology and in the complex process of drug development, and offers an efficient route towards proof of concept in patients. By conducting highly informative early-phase clinical studies, development risks can be minimized and costs can be reduced.
About OmniComm Systems, Inc.
OmniComm Systems, Inc. is a leading strategic software solutions provider to the life sciences industry. OmniComm is dedicated to helping the world’s pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organizations drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. OmniComm provides comprehensive solutions for clinical research with an extensive global experience from more than 5,000 clinical trials. For more information, visit www.omnicomm.com