The first Society for Clinical Data Management (SCDM) Data Driven Innovation Award was awarded to DSG. The Data Driven Innovation Award recognizes excellence in the advancement of clinical data management. The winner was a partnership between DSG and Sirion Therapeutics that used DSG’s eCaseLink/eSource electronic data capture solution product. “We are very pleased to be honored with this award,” said Tony Varano, CEO of DSG. “Our eCaseLink EDC solution enabled Sirion Therapeutics to consolidate the randomization, drug accountability and clinical database of a major trial, saving them critical time and resources.” We’re working on a more extended look at this story.

The Inspector General office of the U.S. Dept. of Health and Human Services (HHS) has issued a report critical of the FDA’s oversight of clinical trial operations. It says clinical trial sites and institutional review boards (IRB) are poorly tracked by the FDA and almost never inspected by a tiny agency staff devoted to the task.

Cmed, a fully integrated contract research organization (CRO), announced the expansion of its senior management team. Alan Eggleston was appointed global head of marketing and sales. Eggleston joins Cmed from his recent position as VP of business development, Europe, at PPD. He will be responsible for both the strategic direction of growth within Cmed and the coordination of all elements of marketing and sales.

The Los Angeles Times published a critique of the industry. The paper quotes the editor of the New England Journal of Medicine and other anti-industry voices. The article notes there is no central and easily searchable database that require drug makers to submit all trial results. That makes it difficult for scientists outside the industry to use data from different trials and make comprehensive studies of the findings, and that can lead to problems similar to those surrounding the Avandia drug. The paper does not address whether the new federal user fee legislation will address the database issue.

LRG Capital Group, a global merchant bank and manager, has invested in VirtualScopics, a provider of quantitative, image-based solutions for clinical trials. Roswell Capital Partners and Gemini Strategies were co-investors in the transaction. Existing investors in VirtualScopics include Pfizer, GE Healthcare, and the University of Rochester. “VirtualScopics has developed state-of-the-art software which is a leap over legacy imaging solutions for clinical trials,” said Lawrence Goldfarb, CEO of LRG Capital Group. “Ten of the top fifteen pharmaceutical and biotechnology companies are turning to VirtualScopics to reduce the costs and time required to conduct clinical trials.”

Simulations Plus, a leading provider of simulation and modeling software for pharmaceutical discovery and development, announced the appointment of John Crison as director, life sciences. Walt Woltosz, chairman and chief executive officer of Simulations Plus, said: “John’s 17 years of R&D experience and 8 years as a registered pharmacist include about ten years working with our long-time collaboration partner, Gordon Amidon of the University of Michigan and Therapeutic Systems Research Laboratories (TSRL), where John was corporate vice president, research and development. He joined Pfizer at La Jolla, California, in 2002, becoming an associate research fellow.”

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