Gastrointestinal clinical trial technology solution to accelerate development and reliability

September 23, 2020

PRINCETON, N.J., September 23, 2020 – Bioclinica, an integrated solutions provider of clinical life science and technology expertise, delivering powerful insight into clinical trial development in bringing new therapies to people worldwide, today announced a strategic partnership with Daniel Mishkin, MD, and GI Reviewers, LLC to develop technology for the interpretation and analysis of colonoscopy videos in clinical trials of inflammatory bowel disease (IBD) including ulcerative colitis (UC) and Crohn’s disease.

The partnership includes Bioclinca’s acquisition of existing technology and intellectual property (IP) developed by GI Reviewers as well as a development collaboration to further extend the technology using machine learning/deep learning methods.

Clinical trials in IBD use colonoscopy examinations to identify the target patient population as well as to evaluate treatment efficacy. Many trials have been successfully completed using central reading of colonoscopy videos to more reliably assess study endpoints. Nevertheless, the variability of central reading can be high even when performed by expert readers.

“Based on our initial investigation, we believe computer automation has a high potential of improving the reliability of central interpretation of colonoscopy videos in UC and Crohn’s disease trials,” said Bioclinica’s Chief Science Officer, Thomas Fuerst, PhD. “This can be done by both assisting expert readers with an enhanced reading environment as well as through automated computer-based assessments of disease severity that are objective and repeatable.”

The exploding application of machine learning in medical imaging is transforming its use in both the clinical and research settings. Particularly in clinical trials, computer-based analysis and interpretation of images can greatly improve the accuracy and reproducibility of imaging endpoints used to assess treatment outcomes. Bioclinica’s Chairman and CEO, Euan Menzies, said, “At Bioclinica we are making a large investment in the application of machine learning methods to the challenges facing our customers in the clinical trial arena. I am excited by the opportunities created by combining our imaging and technical expertise with subject matter experts like Dr. Mishkin and forward-thinking clients looking to bring novel methods to their research programs.”
Bioclinica and GI Reviewers have collaborated to provide high quality central reading in IBD trials since 2012. “Given our common interest in improving IBD trials and ultimately helping patients, in addition to our long and successful collaboration, Bioclinica is the perfect partner to advance this research,” said Dr. Mishkin, CEO of GI Reviewers.

Bioclinica will continue to partner with GI Reviewers and their team of accomplished gastroenterologists for central reading services in clinical trials.

About Bioclinica

Bioclinica is an integrated clinical life science solutions provider, delivering powerful insight into clinical trial development, assuring greater client success in bringing medical therapies to market, for people around the world. Through deep medical, scientific and technology expertise, the company provides medical imaging and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments; clinical trial management software; and drug safety solutions. Bioclinica’s global team of life science experts serve more than 500 pharmaceutical, biotechnology and device organizations – including the top 20 biopharmaceutical companies and leading CROs – through offices in North America, Europe, and Asia.


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