May 26, 2019Bulletins

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Plus: A Diary NDA

Adaptive Tools from Aptiv

February 17, 2012

ER Squared, a clinical trial technology consultancy founded by ex-Bayer executive Robert Musterer, has added another employee. John Fontenault will serve the Connecticut firm as VP of operations. ER Squared advises clients about eclinical challenges, software vendors, biostatistics staffing and data management, among other topics. Says Musterer: "I'm very optimistic. Companies…more...

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Friday News

Biotech Funding Trends

October 28, 2011

Theorem Clinical Research (once known as Omnicare) appointed Adam Serody as VP of global business development. Serody previously worked at PharmaNet and Paragon Biomedical, according to a news release. Parexel will augment its commercialization services group. "Biopharmaceutical companies need to address commercialization goals as early as possible to develop products and…more...

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Hedge Fund Deal

PPD Sold for $3.9 Billion

October 07, 2011

Patient diary firm CRF has shepherded some of its technology through the FDA registration process for medical devices. In a news release, the firm says it is the first among peers to do so: "TrialMax is categorized as a Class 1 MDDS under regulation 21 CFR 880.6310. And because it uses…more...

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Tuesday News

New PPD CEO

September 20, 2011

Easy, convenient SMS messaging has generally been underutilized by the research sector of the pharmaceutical industry, with a quasi-obscure British firm as one of the rare companies that had a vision of what was possible. But ePharmaSolutions is experienced in research-oriented texting, too. It just announced a new version of its…more...

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With Devices News

PPD In Play

August 24, 2011

In a new exercise in government by symbolic gesture, the Obama administration announced a plan to delay or eliminate a small number of federal regulations while simultaneously implementing thousands of new ones. Such announcements typically arrive during the doldrums of the late summer news cycle, when U.S. reporters are even more…more...

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Monday News

FDA: App Regs for Devices

August 15, 2011

Research and Markets has published an $1,800 report on the contract research industry in China. The company estimates that there is a $2.6 billion Chinese market for research services. The bulk of the work appears to be nonclinical and laboratory-related. While there are almost 500 contract research organizations (CROs) operating in…more...

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With FDA, publication news

Parexel Earnings Plummet

August 10, 2011

The medical literature is increasingly inaccurate. That's the sour conclusion of peer-reviewed journal editors and reporters at the subscription-only Wall Street Journal. The rate of article withdrawal has increased 15-fold lately, with more than 200 retractions so far in 2011 alone. Citing data from its own arch rival Thomson, the Murdoch…more...

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With Clinipace, Study Manager

Icon Profits Fall

July 22, 2011

Spectranetics, a medical device manufacturer, chose Clinipace for a restenosis trial in 350 U.S. patients. Here's a release. Drexel University's College of Medicine selected the clinical trial management system (CTMS) of Study Manager. “We sought a CTMS that would help centralize clinical trial data and research processes,” said Donna Walsh, COO…more...

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With Covance, CER

Icon Buys CTMS Firm

July 14, 2011

The OpenClinica solution for electronic data capture (EDC) will be used in trials in Europe and Israel. Projects run by the Safe-T consortium—a €36 million effort which includes Amgen, Lilly, Novartis and Pfizer—will use the free EDC system to detect drug-induced safety issues. Said Ben Baumann, OpenClinica's director of business development:…more...

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With WIPRO, PPD

Academics Slam Medtronic

June 30, 2011

India's Wipro, one of the largest IT consulting firms, has built a specialized clinical trial portal for communication and project/document management. "There is an intensifying need in the market for a platform that can centralize information, manage financing, facilitate accurate reporting, automatic scheduling and provide the ease of patient recruitment," the…more...

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Plus: A Diary NDA

Adaptive Tools from Aptiv

With news about ER Squared, the NIH, China, Oklahoma, Insys, invivodata, and Aptiv

Friday News

Biotech Funding Trends

With news about Theorem Clinical Research, Parexel, FDA, BMS, AstraZeneca, BBK, TrialReach and Ernst & Young

Hedge Fund Deal

PPD Sold for $3.9 Billion

With news about CRF, FDA biosimilars, Merge, Dell, Pointcross, Bio-Optronics, Quintiles and PPD

Tuesday News

New PPD CEO

With news about SMS, ePharmaSolutions, Quintiles, public knowledge of FDA, BioClinica, OmniComm, PharmaPros and PPD

With Devices News

PPD In Play

News about FDA, medical devices, Pfizer, Quintiles, the Carylyle group and PPD

Monday News

FDA: App Regs for Devices

With news about China, CROs, obesity, BioClinica, biotechnology and device-related app regulations


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