CenterWatch Monthly May 2009

Friday, May 1, 2009 11:00 AM

U.S. Sites Rate Novo Nordisk, Novartis and Eisai as Top Sponsors in 2009

Results of the CenterWatch 2009 Survey of Investigative Sites in the U.S. are in. For the second time in a row, U.S. sites have rated Novo Nordisk and Novartis the top one and two sponsors to work with, respectively. Eisai was ranked third by U.S. sites, a very high ranking considering that it is the first time that the company has elicited a significant response.

The total number of U.S. investigative sites responding to CenterWatch’s survey was 950, up nearly 50% the last time the survey was conducted two years ago. According to nearly half of responding sites, contract and budget negotiations are the factor that causes the most study delays.

CROs Going Private

Three large global CROs—Quintiles, PRA and PharmaNet—have gone private in recent years. Though each had company-specific reasons for the move, other large CROs may also want the freedom to pursue a long term strategic vision without worrying about the quarterly reporting demands of Wall Street.

Industry analysts believe that two or three small to mid-size public CROs that have weak financial results may consider going private in upcoming months, and a recent survey of public companies revealed that nearly one-quarter of respondents were considering going private due to corporate governance and disclosure reforms.

Inspection Programs Move from Retrospective to Risk-Based in Europe

Until the Clinical Trials Directive (2001/20/EC) went into effect five years ago, Good Clinical Practice (GCP) inspections were conducted retrospectively, often voluntarily and only with marketing authorization (MA) application. Now all 27 member states have at least one GCP inspector, and European Medicines Agency (EMEA) is using this collective body of expertise to widen the scope of inspections and push its prospective inspection program forward.

Eye On: Gastrointestinal Diseases

Gastrointestinal diseases may affect different sites in the entire digestive system from the mouth to the esophagus, stomach, small intestine, colon, rectum and anus. The liver, gallbladder and pancreas also secrete enzymes needed to break down and metabolize ingested food.

Symptoms of gastrointestinal disorders may include blood in the stool (melena or hematochezia), altered bowel habits, diarrhea or constipation, severe abdominal pain, unintentional weight loss and heartburn not responding to antacid treatment.

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May 18

Research for All Act reaches Congress for second time seeking gender equality in basic research, clinical trials

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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