
Taken from the NEW Good Clinical Practice: A Question & Answer Guide 2013. Order Here!
Question: Has this increased focus on sponsors’ quality systems had any implications for the FDA’s inspections of trial sponsors? Although traditionally it has conducted far fewer inspections of sponsors/monitors and CROs, what has CDER found in such inspections more recently?
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Barnett International Announces New SOP Development and Optimization Courses
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The PAREXEL Biopharmaceutical R&D Statistical Sourcebook is the industry's leading resource for statistics, trends, and proprietary market intelligence and analysis on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analyses, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development – from product discovery, to R&D performance and productivity, to time-to-market analysis. Mark Mathieu is the Editor of the Sourcebook, and director of strategic research at PAREXEL Consulting. In this interview, he discusses the emerging metrics and benchmarks on the current state and direction of today's biopharm industry, industry activity in clinical development, metrics by therapeutic area, and clinical trials in emerging markets.
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Download this podcast to hear about all new updates to the current Good Clinical Practice Question & Answer Reference Guide, May 2012. Answering hundreds of questions about GCP, the book is the must-have resource for CRAs, investigators/sites, auditors, compliance, legal, and other clinical research professionals. In this podcast, the editor of the book, Michael Hamrell, discusses what's new in 2012, such as the FDA's guidance related to risk-based monitoring approach to clinical trials, and the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance.
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Listen to this podcast to hear Anne Blanchard, Founder of Blanchard & Associates in Buenos Aires, Argentina, and author of the Latin America section of the GCP Question & Answer Reference Guide 2012 chapter, "Clinical Trial and GCP Standards in Selected Leading Regions," discuss best practices in GCP in leading Latin American countries. Covering topics such as the regulatory framework and process, informed consent, GCP monitoring by regulatory authorities, all with country-specific information.
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This exclusive podcast is with Dr. Beat Widler, the key contributor to this year's GCP Q&A Guide's Chapter on "GCP and Clinical Research Standards in the European Union." Hear Dr. Widler's take on issues such as global outsourcing, the pitfalls and opportunities related to global drug development, and the sharing of protocols and protocol standards across industry.
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