CenterWatch Monthly May 2009
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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