Outsourcing

Articles

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.”

EMA Recommends Suspension of 700 Drugs Tested at GVK Site

Scott Maisto is associate director, strategic finance at PPD, Wilmington, NC; email: ppdinfo@ppdi.com.

Bryan Haas is vice-president at PPD, Wilmington, NC; email: ppdinfo@ppdi.com.

Dave Agrella is executive director, Functional Service Partnership at PPD, Wilmington, NC; email: ppdinfo@ppdi.com.

Evolving clinical trial research services give biopharmaceutical companies options for full and functional services.

Weighing Clinical Trial Outsourcing Options

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.

Clinical-Trial Material Supply by Way of Shanghai

Janis Hall is a senior consultant at The Avoca Group

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.

Managing Clinical Development Risk: Pharma and CRO Report

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Clinical research organizations see reform in clinical-trial process, including the establishment of chief innovation officer at FDA.

CROs Urge for Modernization of Clinical Trials

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

Quality Issues for Multiregional Clinical-Trial Materials

The author analyzes the results of a survey that polled pharmaceutical executives and managers about both sides of the outsourcing relationship. Read this and other preferred organization articles in this special issue.

The Future of Clinical Service Provider-Sponsor Relationships

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

FDA's final rule on clinical trials

As emerging markets become increasingly important for the pharmaceutical majors, companies are re-evaluating their outsourcing strategies. This article is part of the 2010 Outsourcing Resources special issue.

Contract R&D and Clinical Materials Outsourcing in Emerging Markets

Pfizer Ends Second Tanezumab Clinical Program; Catalent VP Joins USP Panel; And More.

Contract Research Services