Clinical Trials Articles

Projections "made by various industry analysts and market research companies...vary" on clinical trial growth in the Asia-Pacific region, but "estimates project growth of clinical research in China and Korea to be 25% and 30% per year, respectively," observed Stanford S. Jhee, PharmD, senior director of research, early phase development, for Parexel.

CTMS Addresses Small–Midsize Company Needs

Enhanced version is integrated with IVRS/IWRS and EDC

Perceptives enhanced TrialWorks 2.1

The recent Bayer incident in which two products had received warning letters from the FDA and were voluntarily withdrawn from market in late October has made it apparent that though these combination products—a drug combined with a dietary supplement—are not common, there may be a lack of understanding of where they stand on the regulatory front.

As an active member of ICR (Bourne End, UK) for more than 20 years and a clinical research consultant for Ipsen Ltd (Slough, UK), Graham Belgrave has been recognized as the 100th ICR Chartered Scientist.

Megan Sturm

The concept of supply chain automation has revolutionized manufacturing and distribution processes during the past two decades, and has resulted in dramatic ongoing business opportunities for large software and consulting companies such as SAP and Oracle.

This month, Applied Clinical Trials highlights the Academic Medical Center and its role in clinical trials. We have provided this special issue, focusing on different aspects of this segment, to provide insight into the AMC as it too turns toward a new decade, and new changes in drug development.

The European Union lurches into another difficult year, with—for the first time ever—the Czech Republic holding the rotating chairmanship for the next six months, and consequently largely responsible for setting the agenda.

The new administration, Congressional leaders, payers, and providers are eager to transform the nation's health care system to curb unnecessary spending and make coverage more fair and efficient. The main problem is that the U.S. health care bill keeps rising faster than the rest of the economy, with little to show in quality improvement.

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John Tomera

* Joining WorldCare (Boston, MA) as director of regulatory affairs and associate medical director, John Tomera will become responsible for managing all quality assurance and regulatory affairs operations.

Elaine Taylor

Rater reliability is the cornerstone of data accuracy for drug trials that depend on clinician-rated subjective instruments to assess efficacy. Every pharmaceutical company seeks unambiguous evidence that its product is the new best treatment for a given disorder.