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February 01, 2016
Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.
Mergers and acquisitions have changed the shape of the contract services market as big players seek to build full-service capabilities.
Only half of new drugs make it past Phase III. Adopting best practices and collaborating more closely with contract research organizations can help ensure success.
September 08, 2015
The partners will collaborate on a project to capture and integrate clinical trial data metrics on investigational cancer medications.
May 26, 2015
EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.
April 15, 2015
Pfizer announces that its Phase III trial for Ibrance met its primary endpoint and was ended early due to efficacy based on an assessment by an independent Data Monitoring Committee.
January 23, 2015
EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”
August 01, 2014
Evolving clinical trial research services give biopharmaceutical companies options for full and functional services.
February 01, 2014
Geographic location, customs and drug-development regulations knowledge, and transportation infrastructure were factors in Catalent Pharma Solutions' selection of Shanghai for its clinical-trials supply facility.
The relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development.