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AUGUST 06/2019


news roundup

Research Partnership Studies Heart Failure Measures

Biofourmis, a digital therapeutics provider, has entered a research partnership with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI), a joint effort between Yale University, Mayo Clinic and the FDA. Biofourmis' mobile platform BiovitalsHF will be used in a study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis should be placed on these measures in the drug approval process.


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CTI Collaborates in South Korea

CTI Clinical Trial and Consulting Services, a multi-national CRO, has signed a Memorandum of Understanding (MOU) with Samsung Medical Center (SMC), located in Seoul, South Korea to advance clinical research in fields such as rare and orphan disease, regenerative medicine, and hematology/oncology.


Novotech Partners in Singapore

Novotech, an Asia-Pacific CRO, has further strengthened its presence in the region through a Partnership with the Skin Research Institute of Singapore (SRIS) to promote combined capabilities in skin research clinical trials.


Articles

Study Shows Low Awareness of NASH

Continuum Clinical conducted a survey of 1,014 adults in the U.S. and found only 2% were aware of NASH. A follow-up study of 450 adults with comorbidities associated with NASH revealed only 6% were aware of the disease.


The Revised Common Rule

Components that are essential to the informed consent process include the person presenting the research opportunity to potential subjects, and how thoroughly they have been trained in matters related to effective communication with subjects, the role of the consent document in the initial consent discussion and the ongoing process that consent is supposed to be.

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In this edition

AI Mitigates Placebo Response
Research Partnership Studies Heart Failure Measures
The Revised Common Rule

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AI Mitigates Placebo Response

In this interview, Dominique Demolle, CEO of Tools4Patient, will discuss the effect AI is having on the statistical impact of clinical trial placebo response by creating personalized baselines per patient with AI.


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Lisa Henderson
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LHenderson@mmhgroup.com

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Todd Baker
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