July 29, 2014fda

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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 newspaper reviewed examples of notorious scientific articles that were later retracted. Career pressures in academia are cited as the prime reason for mistakes. The silver lining? Some experts say the scientific community may be getting better at detecting problems. The roles of industry pressure or deliberate fraud aren't explicitly explored. Retraction Watch is a blog devoted to the topic; one of its authors is a Harvard-trained physician. Philadelphia patient recruitment firm Acurian is using a system with elevated IT security from Oracle. In a news release about the importance of strong data encryption, Andrew Fichter, Acurian’s chief privacy officer, had…more...

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CDER Chief On OMOP

Woodcock At Harvard

May 11, 2011

Like those who work in quarries and mines, journalists covering the pharmaceutical industry wear special ear protection while on the job. It's all required by OSHA and has greatly advanced over…more...

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DIA Web Seminar

FDA Pushes For E-source

March 03, 2011

Late last year, the FDA released a draft guidance on electronic source, or "e-source." It's not as exciting as rebelling Libyans or Charlie Sheen's rants, to be sure. But the ramifications…more...

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Temple, O'Neill At DIA

Global Doubts

July 12, 2010

As the industry scrambles to find the patients it needs outside the U.S., the organizers of the 2010 annual Drug Information Association (DIA) in Washington, D.C. decided to assemble the sort…more...

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Lax Trial Oversight

HHS Assesses FDA Overseas

July 07, 2010

Are international clinical trials regulated? By the FDA? By anyone? In gentle language, the U.S. Department of Human Services says that one of its own fiefdoms, the FDA, has been unable to keep up with the rapid growth in clinical research outside America. The push to find clinical trial patients outside the U.S. is not news. But…more...

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2010 Keynote Address

Hamburg At DIA Annual

June 17, 2010

The 2010 annual Drug Information Association meeting began with a new dual-element musical interlude. The first composition amounted to elevator music, by an anonymous band inspired by the hard rock of Van Halen. The purpose of that aural interlude? To inspire and energize. The second musical offering at DIA, a live string quartet (performers on stage with…more...

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Converging Data Challenges

How To Help FDA

June 10, 2010

Not long ago, the Drug Information Association (DIA) and FDA’s two most important divisions, CDER and CBER, held a joint meeting. Its title was less than intuitive: “Computational Science Annual Meeting.” But the goal of the meeting was laudable and significant to everyone in clinical research. The idea was to explore how technology, broadly defined, could help…more...

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Not An SMO

AMR: An 18-Site Alliance

June 09, 2010

In the early 1990s, site management organizations (SMOs) began to form. The idea was simple. Sponsors would be happier if they could go to a single company that served as the management headquarters of many sites, instead of having to approach many disparate, individually run sites separately and forge contracts with each. SMOs like Radiant Research started…more...

All Sites Benchmark

MCC Goes Sigma

Quality-improvement principles infiltrate metrics in a far-reaching industry collaboration.

Rising Star

Medpace Rated Highly

The CRO is loved by sites and has ex-FDA scientists in top executive positions.

Our How-To

Special Protocol Assessments

To double-check that Phase III protocols are viable before a study starts, sponsors can approach the FDA for a quick sign off.

China Purchase

PPD to Spin Off, Acquire

The CRO announces some restructuring of business development.

Tuesday News

India Trials Report

WIth bulletins about DZS, NextDocs, Lab Research, MDS, Phase Forward and India.

Exit Strategy

MDS Pharma To Be Sold

MDS never quite recovered from an FDA audit, and is now trying to sell MDS Pharma Services.

Tuesday News

Warner Chilcott To Buy P&G’s Pharma Business

News from FDA, Parexel, PPD, Ligand Pharmaceuticals, D-Pharm and Orexigen.


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