Featured Content

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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Preparing sites for acquisition

Saturday, July 1, 2017

The unprecedented level of M&A activity in the clinical research site sector during the past 24 months has spurred many investigative site owners to consider selling their businesses.

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Standard data, extraordinary innovations in clinical trials

Saturday, July 1, 2017

As clinical trials require more robust and user-friendly systems to monitor data and conduct effective risk-based monitoring, the use of industry data standards can greatly drive efficiencies and reduce variations in data format from one study to the next. The increasingly wide acceptance of Clinical Data Interchange Standards Consortium (CDISC) standards, and subsequent requirement of the CDISC Study Data Tabulation Model (SDTM) standards , has opened innovation opportunities within the industry.

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