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U.S. Slips On Mega Projects

Top 2010 Trials

January 06, 2010

Which organizations are running the biggest, most complex portfolios of clinical trials in 2010? To find out, ClinPage analyzed the listings in ClinicalTrials.gov, the U.S. government's database of more than 80,000 research projects. Our exclusive list of the 50 largest ongoing studies is below. The list is a magnificently global one. Many of the top organizations tend…more...

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Fearless With Sponsors

Palm Beach Research

January 05, 2010

A successful stand-alone investigator site—one not affiliated with an academic institution, a hospital or any other sites—is a rarity in clinical research. Most sites that try independence find that they can't find a steady flow of studies. Palm Beach Research Center is an exception. The 15-year-old, 25-employee investigator site chugs along with many Phase II and III…more...

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Private Equity Buyer

MDS Sells Central Labs

October 14, 2009

The corporate parent of contract research organization (CRO) Chiltern bought MDS Pharma's central labs. Last week, private investment group Czura Thornton agreed to pay $8 million for the labs and an additional $4 million later if performance thresholds are met. The sale is part of Canadian conglomerate MDS Inc.'s continued selling of clinical assets, including MDS Pharma…more...

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Knowledge Gap

A Deep Process Problem

September 24, 2009

Those who do not know history are doomed to repeat it. Dogs do it. Frogs do it. Logs do it. (At least as long as they are part of the tree.) Companies do it. Even ones like GM, even if they have to be forced. Moving forward, I mean. Evolving. Keeping things that work and discarding things…more...

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Staying On Track

Icon: This Too Shall Pass

September 23, 2009

Not so long ago, Icon Clinical reached the final stage of getting regulatory approval for a large global project involving a new diabetes drug. As fate would have it, the FDA issued a warning letter about another drug in the diabetes category. The regulatory counterparts to the FDA elsewhere in the world said a collective whoa.In…more...

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Robust Growth

New Parexel Sourcebook

July 20, 2009

There are more active, commercial investigational new drug applications (INDs) circulating through the FDA than ever. Exactly 5,700 at the end of 2008. That's a record high—up 20 percent over the previous year. For now, clinical programs do not appear to have been affected by the larger economy. Numbers of filings are surging, too. A record 795…more...

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Vagelos Podcast

Merck’s Wise Man

May 29, 2009

Most of the ClinPage podcasts are done in a pretty typical Q&A format. Today, however, we're posting a different type of audio: some snippets from the 2009 Clinical Trials Congress, held earlier this year. We thank the Institute for International Research (IIR), which organizes a fabulous conference every year, for their permission to do this. The speaker…more...

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Reuben, Baystate, Pfizer

Exclusive: Fraud Postmortem

March 20, 2009

So much for multimodal pain therapy. A leading proponent, anesthesiologist Scott Reuben, is watching his abruptly damaged reputation. The fraud continued for twelve years, from 1996-2008. More than twenty of Reuben's thirty peer-reviewed articles have been retracted or are being reassessed. It's a black day for peer review. The honor system. And anesthesiology. What industry critics will…more...

March 14, 2010

Reuben, Baystate, Pfizer

Exclusive: Fraud Postmortem

A research scandal at a Tufts facility shows that peer review cannot identify scientific fraud quickly.

Whale Watching

Projecting Pfizer Revenues

Thoughts on the numerical implications of the impending mega mergers between Pfizer-Wyeth and Merck-Schering-Plough.

Rx For 2009

Obama’s Biggest Problem

Reflections on the new year and what pharma should do to avoid a pounding from politicians.

Litigation Avoidance

How to Not Get Sued

To avoid lawsuits, train employees to pretend a lawyer is reading every email, text message and Microsoft Word document.

Setting The Record Straight

The Future of ODM, SDTM and CDISC

Despite a cancelled FDA pilot project, CDISC leaders explain why the ODM data standard still matters.

100 Languages Spoken Here

Profile: Global Language Solutions

With ISO certification, a California firm tries to lower regulatory risks inherent in translation by ensuring high quality—and avoiding mistakes.


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