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Tuesday News

Covance, WuXi Drop Deal

September 30, 2008

The FDA said an analysis of 41 trials suggests the statin class poses no risk of Lou Gehrig’s disease. There are anecdotal reports of other central nervous complications with the statin class that remain unresolved. Here’s the agency’s statement. Bio-Imaging Technologies appointed Peter Benton as president of its electronic data…more...

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Monday News

Trial Publication Lag

September 29, 2008

Merck will join Lilly in disclosing almost all physician payments. The company said it supports pending federal legislation to require the disclosure of payments. Here’s the release and an article. Microsoft is encountering a variety of problems. Business Week recently noted that HP is working on a shadow operating system,…more...

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Friday News

Kendle In Fortune 100

September 26, 2008

The Pittsburgh electronic patient-reported outcome (ePRO) firm invivodata announced its technology captured secondary endpoint data in a study of elagolix in endometriosis. Said Chris O’Brien, chief medical officer, Neurocrine Biosciences: “invivodata’s process for designing and implementing ePRO was comprehensive and straightforward, and easily fit within our clinical development timeline. When…more...

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Thursday News

Award for Oracle CTMS

September 25, 2008

Search engines just unearthed an April news release for us. Frost & Sullivan picked Oracle as the 2008 North American Market Leadership Award recipient for clinical trial management systems (CTMS), recognizing Oracle’s Siebel CTMS. Frost & Sullivan selected the winner based on revenue and market share. “We are impressed with…more...

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Wednesday News

Commonwealth Anthrax Tool

September 24, 2008

Accelerated Community Oncology Research Network (ACORN) named Tara Webb as senior director of business development. Webb brings a successful record of establishing and cultivating contract research organization (CRO) relationships. “Tara Webb has an exceptional background of work in the CRO field and is widely respected for her industry knowledge, capabilities…more...

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Monday News

FDA Safety Newsletter

September 22, 2008

Octagon Research issued a release noting that it is helping the Clinical Data Interchange Standards Consortium (CDISC) train the FDA as part of a two-year contract to train agency personnel on regulatory submissions and data standards. Fred Wood, principal consultant and lead of the data standards consulting group at Octagon…more...

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Thursday News

CDISC FDA Training Contract

September 18, 2008

Clinipace, a provider of electronic data capture, announced ten new contracts collectively valued at more than $1 million. The North Carolina firm estimates it can offer cost savings of 30-50 percent compared to what more established competitors charge. “We are committed to serving the needs of emerging and mid-tier biopharmaceutical…more...

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Wednesday News

2008 Reg Affairs Pay Survey

September 17, 2008

Mission3 announced a major new release of its internet-based project and document management tool. The company’s software now supports non-eCTD Submissions such as 510ks, PMAs, combination products and/or study reports. The press release notes web-based authoring of scientific documents. The pricing is $2,900/month with no other setup or IT fees.…more...

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Tuesday News

Pfizer Drug Safety Page

September 16, 2008

Nextrials hired replacements for two key executives. Anthony Costello and Robert Lyons left the California electronic data capture (EDC) firm earlier this year. Now Robert Barr is coming in as chief technology officer; he is a former VP of software engineering for ClinPhone, which has just been acquired by Parexel.…more...

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Monday News

Octagon Raises $12 Million

September 15, 2008

Clinical suite DataTrak International is suing executives who came aboard as part of the ClickFind acquisition. DataTrak alleges that the sellers in that $18 million transaction misrepresented their authority to sell their own software, which (unbeknownst to DataTrak) had already been licensed to a contract research organization, Emissary. That licensing…more...

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December 3, 2008

Friday News

ProTrials Wins Award

Bulletins on Encorium, PDI, SRA International, GSK, NPR, Halloran Consulting Group and ProTrials.

Thursday News

WuXi in Deloitte Fast 50

News about WorldCare Clinical, WuXi PharmaTech, etrials, Peak 10, AstraZeneca, Recipharm and Clinilabs.

Tuesday News

Averion Revenues Double

With news about PharmaVigilant, Merck, adaptive trials, Omnicare, Google, Genentech and Averion.

Monday News

Icon Buys NY Lab for $35M

With news about FDA, drug safety, Inc Research, Prescription Project, SAS, and Icon.

Friday News

New etrials CEO

Bulletins about SCDM, WuXi PharmaTech, Averion, Biotrial, FDA communications and etrials.

Thursday News

Lilly Pediatric Diabetes Donation

Bulletins on Spherix, Icon, Lab Research, Acorn CRO, Lilly and AAIPharma