Clinical Data Management/eClinical

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Clinical Data Management/eClinical

Sanofi and Regeneron Announce Regulatory and Clinical Update for ZALTRAP^® (aflibercept) ZALTRAP BLA for metastatic colorectal cancer granted priority review by FDA; drug phase III study in prostate cancer did not meet primary endpoint. Read more...

Clinical Data Quality Summit
April 24-25 | Philadelphia, PA

Learning Objectives:At the conclusion of this conference, participants should be able to:• Describe tools, technologies, and techniques that impact data quality
• Discuss best practices to ensure successful design of studies, while embracing standards
• Define who to include during the study start up phase to ensure that all elements are addressed
• Explain how research professionals can work effectively together during the conduct of a clinical trial
• Identify steps to successfully clean and lock a database by establishing partnerships with clinical and biostatistics
• Discuss regulatory expectations for quality data and recommendations for study start, conduct and closeoutTarget Audience:• Data managers
• Clinical project managers
• Clinical research coordinators
• Principal investigators
• Data standards personnel
• Monitors
• Quality assurance personnel
• Regulators
• Statisticians
• Clinical programmers

Introduction to Computer Systems Validation
Begins April 30 | Online

Learning Objectives:At the conclusion of this activity, participants should be able to:
· Contribute positively to a project
· Validate a computer system
· Manage a computer systems validation project
· Use computer systems validation procedures within your organization
· Implement quality and risk procedures into computer systems used in your organization

Target Audience:
· Computer system users
· Auditors
· Quality assurance professionals
· Regulatory affairs professionals
· Information technology professionals