news roundup
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 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, 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.
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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.
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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