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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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Friday News

BMS: Accenture Deal, FDA Rebuff

September 12, 2008

SAFE-BioPharma and the Clinical Data Interchange Standards Consortium (CDISC) have announced they will collaborate to advance the electronic exchange of information across the global biopharmaceutical and health care communities. Specifically, the two groups are developing a specification to enable the CDISC operational data model (ODM) to accept SAFE digital signatures…more...

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Thursday News

MedNet On Inc. 5,000 List

September 11, 2008

Quintiles will double the size of a regional headquarters in Singapore and raise its profile in Asia. “Quintiles is the largest and fastest growing clinical development group in Asia,” said Dennis Gillings, chairman and CEO. “Since entering the region in the 1990s, we have built a strong staff of 2,800…more...

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Wednesday News

Rho Wins $39M NIH Project

September 10, 2008

Texas-based Pharm-Olam International said net service revenue grew by 47 percent for the first half of 2008. The private company didn’t release any dollar amounts. Said Iain Gordon, VP of global business development: “We are on track for another year of record sales. We have the largest global spread of…more...

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Tuesday News

UNC Drug Safety Center

September 09, 2008

Prostate-specific antigen (PSA) screening may be complicated by aspirin and other pain relievers. So says Reuters. A recent study of 1,319 men suggests men taking painkillers had 10 percent lower PSA levels. With eyes wide, the Wall Street Journal medical blog has discovered ... electronic data capture (EDC). Which is…more...

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Monday News

FDA Safety Watch List

September 08, 2008

Praxis released a new version of its patient recruitment software, with enhanced views and reports available via an internet portal. Says the company: “PraxisDirect 2.0 collects Praxis pre-qualified candidate data through the centralized recruitment center, as well as integrates data from sponsors IVRS/CTMS systems.” Here’s a release. MDS Pharma reported…more...

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Friday News

Phase Forward Buys Clarix

September 05, 2008

Bridge Laboratories announced that the FDA accepted data submitted from its Beijing facility on behalf of a U.S. biotech client. The Good Laboratory Practices (GLP) nonhuman primate toxicology data was submitted last month as part of an IND package. Bridge’s Beijing facility was built to conduct GLP studies in support…more...

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January 8, 2009

Monday News

PRA Expands In Mexico City

Bulletins on Pharm-Olam, Kika, breast cancer award, PRA, medical ghostwriting, ACRP and the Shanghai Clinical Research Center.

Friday News

Pentagon Drug Safety Project

Bulletins on Icon, Isis, AAALAC, MDS Pharma, DataTrak, Pantheon, and PhaseForward.

Thursday News

Thermo Fisher Facility In India

Bulletins on MDS, Cmed, Roche, Bio-Imaging, AG Mednet, Decision View and Thermo Fisher Scientific.

Wednesday News

Agenda for Clinical Trials Congress

Bulletins on Parexel, SITS, Cortia, asthma, SeraCare, PDL Biotech and the Clinical Trials Congress.

Monday News

ThotWave Joins CDISC

Bulletins on ThotWave, CDISC, FDA, AstraZeneca, APP Pharmaceuticals, Velos, University of Kansas, VirtualScopics and ISSCR.

Friday News

UK Pfizer Picks Exco Gadgets

Bulletins on Decision View, OpSource DIA, PRA, FDA, WebMD, Phase Forward and Pfizer UK.