Medical Device Trials | Applied Clinical Trials

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•	CRO Expands to U.S.
•	eClinical Device Study
•	FDA Device Advice
•	Postmarket Safety Data
•	510(k) Premarket Examined
•	CRO Changes Name

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November 4, 2009

Premier Research Expands Medical Device Operations to US
CRO Premier Research Group, offering medical device clinical trial services in Europe since 1997, expanded those services to the U.S., and is being led by Efraim Roe Kozorovitsky, Executive Director, Medical Devices, and a four-year veteran of the company. More...

Datatrak Signs 6-Yr Study
eClinical solutions provider Datatrak signed to provide services to a six-year, U.S.-based study with a device client evaluating the use of a thoracic stent graft in aneurysm repair. More...

FDA Advises Investigators on Medical Devices
In a finalized Guidance for Industry, Investigator Responsibility—Protecting the Rights, Safety, and Welfare of Study Subjects issued October 2009, included an Attachment B: Investigator Responsibilities for Significant Risk Device Investigations. The attachment describes specific investigator duties related to investigational medical device trials and their management. More...

FDA’s Electronic Safety Reporting Proposed for Devices
The FDA’s changes to postmarket safety reporting regulations will extend to the Center for Devices and Radiological Health (CDRH). Currently, CDRH receives most of its mandatory medical device adverse events reports on paper, and then manually entered into the centers MAUDE database. More...

Premarket Clearance Process Goes to IOM
The FDA announced that the Institute of Medicine (IOM) has been commissioned to examine the premarket notification program or the 510(k) process for medical devices. The CDRH, in parallel, will evaluate the same process. More...

Name Change to Novella Clinical
PharmaLink has changed its name to Novella Clinical and will continue to serve its biopharmaceutical clients with Phase I through postmarketing programs and its medical device clients with Class II and III device programs. More...

Key Topic Updates

Regulatory

Medical Device Compliance

Combination Drugs and Devices

FDA’s Proposed Rule for Postmarketing Safety Reporting for Combination Products

Community

ClinOps Adds Senior VP of Clinical Operations

Cutera Promotes Employee to Lead North American Sales Organization

SonoSite Appoints Senior VP of Strategic Development and Patient Safety Innovations

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