Clinical Investigation Site Summary: Integrity Clinical Research Treating Nonalcoholic Steatohepatitis (NASH)

Clinical Investigation Site Summary: Integrity Clinical Research Treating Nonalcoholic Steatohepatitis (NASH)

In an ongoing effort to provide our readers the most relevant and useful news regarding clinical research, we are covering Integrity Clinical Research in Doral, FL. They are one of over 300 clinical investigation sites involved in a new treatment for Nonalcoholic Steatohepatitis (NASH). Also see our coverage of The Institute for Liver Health in Arizona and the Fresno Clinical Research Center in California.

About IRC

As described on their website, “Integrity’s staff has over 35 years of clinical research experience in South Florida. All staff members are fully bilingual medical professionals with research experience in both the private and academic settings. Our seasoned Principal and Sub-Investigators provide Integrity with access to a large network of primary care physicians and specialists with admitting privileges at the largest facilities in the area.

“Once awarded, our staff will design a personalized recruitment strategy for your trial using a database containing over 10,000 prescreened subjects covering all medical conditions. Together, our team will review every aspect of your protocol in order to develop a plan of implementation that will offer your trial the highest chances of success when applied to South Florida’s unique demographic.”

Study Sponsor

The sponsor of this study is Genfit, a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases where there are considerable unmet medical needs, corresponding to a lack of approved treatments.

Study Title, Dates, and Participation

The study is officially titled: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis.” The start date was in March 2016 and the end date is planned for December 2021. Patients are currently being recruited for this study, and it is estimated to have over 2,000 participants.

Key Principal Investigator

TrialSite News researchers were not able to identify the key principal investigator at Integrity Clinical research, as their staff was not listed on their site and Google was of no help.

FDA Findings & Online Presence

There were no significant FDA findings that our researchers were able to identify. And when digging into their online presence, they had no reviews and little activity on their Facebook page, they did not have a Yelp page, and their Google listing showed one review.

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