Weekly Features

Crohn’s & Colitis Foundation launch Clinical Trials Community

Monday, July 31, 2017

On July 20, 2017, the Crohn’s & Colitis Foundation launched a Clinical Trials Community (the Community) for the education of patients, family members, caregivers and healthcare providers regarding the study of irritable bowel disease (IBD). Specifically, the community will provide education on the clinical trial process as well as its value for facilitating improvements in care. Subsequently, this process may help reduce barriers to patient enrollment in IBD clinical trials, thereby enabling faster routes to therapeutic discovery.

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Partnership unveils EHR-EDC integration

Monday, July 24, 2017

Two industry innovators have joined forces to take the lead in real-world studies. Clinerion and Cisiv have formed a groundbreaking partnership to offer a revolutionary approach to observational research by enabling automated data transfer from electronic hospital records (EHRs) to electronic data capture (EDC).

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Mayo Clinic and nference form Qrativ, AI platform for developing rare disease therapies

Monday, July 24, 2017

The Mayo Clinic and nference, a healthcare data synthesis company powered by artificial intelligence (AI), recently announced they’re joining forces to form the startup company Qrativ. This startup will combine nference’s AI knowledge synthesis platform and the Mayo Clinic’s experience and expertise in medicine and healthcare to identify and develop new therapies for patients where an unmet need exists. Orphan diseases have been chosen as the prime focus of Qrativ’s efforts.

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Innovation Initiative to modernize the FDA

Monday, July 17, 2017

New FDA Commissioner Scott Gottlieb intends to release a far-reaching plan aimed at modernizing regulatory processes and speeding approvals for new drugs and devices, which could allow greater patient access to new medicines through unprecedented scientific and technological advancements.

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FDA announces new Orphan Drug Modernization Plan to eliminate orphan designations backlog

Monday, July 10, 2017

On June 29, 2017, the U.S. Food and Drug Administration (FDA) announced a recent initiative for the eradication of the agency’s orphan disease designation request backlog. This backlog includes around 200 orphan drug designation requests. In addition to eliminating this backlog, the FDA has in place a new strategic plan of action for the prevention of a future requests backlog via the implementation of a 90-day response system.

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Skipta-Continuum launch real-world, observational studies joint venture

Wednesday, July 5, 2017

The launch of the Center for Observational Research by Skipta and Continuum Clinical aims to create opportunities for physicians to participate in real-world studies. These are noninterventional, observational studies that do not take place at the academic centers and trial sites one usually associates with clinical trials. The intriguing aspect is that this center exists entirely online. It is a network designed to connect interested physicians with observational studies smoothly and efficiently, and to accelerate the pace of enrollment and data collection.

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