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CenterWatch Monthly October 2009

Monday, October 5, 2009

The Changing Role of Clinical Data Manager

EDC technologies for data collection, along with growth in outsourcing data collection responsibilities to CROs and information technology companies, has dramatically changed the job expectations for clinical data managers.

Membership in the Society for Clinical Data Management, the largest clinical data management society in the world, has grown an average rate of 15% per year during the past five years, and now stands at more than 2,600. The size of the global outsourced clinical data management market is estimated at more than $1 billion.

Comparative Effectiveness Funding Presents Opportunity, Uncertainty

The American Recovery and Reinvestment Act, signed into law in February, contains $1.1 billion for comparative effectiveness research (CER). The IOM and the Council both issued recommendations to the president and Congress about what shape this research would take. 

Opportunities for CER funding exist for CROs, academia and patient organizations, but a CER infrastructure must be created, standards developed and privacy issues addressed for physicians, patients and the public to reap the full benefits of this research.

FDA/EMEA Initiative Aims for More Efficient GCP Monitoring Worldwide

As the costs of good clinical practice (GCP) assurance and enforcement continue to grow, agencies and sponsors alike are striving to optimize limited resources. A new initiative between the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) involving GCP inspection processes is designed to benefit stakeholders and curb unnecessary expenditure.

Eye On: Breast Cancer 

Worldwide, breast cancer is the most prevalent cancer among women. In 2008, about 182,000 women in the United States were diagnosed with breast cancer, and more than 40,000 died from the disease, according to estimates from the American Cancer Society.

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