Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
Effective process improvement can be key to reducing delays and improving data accuracy. In clinical trials, turnaround time and data accuracy are critical. Likewise, the contract research organization (CRO) level or the institutional review board (IRB) level can have serious downstream effects, negatively impacting study efficacy and time-to-market. It is essential, therefore, that all participants in clinical trials – sponsors, CROs and IRBs – take steps to improve both efficiency and accuracy.
Why Should You Attend:
In this session, we will review the main principles, practices, and methodologies for implementing continuous quality improvement and risk-based management of clinical trials.
Course Outline:
• Discuss evolving challenges with different phases of clinical studies for Sponsors, CROs, third-party vendors and sites
• Define areas in clinical research which need to maintain high-quality standards and discuss the Need for Improvement
• Understand the quality improvement process and strategies
• Discuss how to optimize the process and improve efficiency and quality of research conducted (continuous quality improvement)
• Address strategic planning and budgetary consideration
• Determine critical factors for selecting and training clinical trial sites, vendors, contractors
• Plan, develop and implement effective process improvement and study management strategies
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Directors of Clinical Operations
• Medical Affairs specialists and leaders of this division
• Project Managers
• Staff from Pharmaceutical/Device Companies or Contract Research Organizations (CROs) involved with the management of clinical trials
• New clinical or other Project Team Leaders who will be managing projects
• Clinical, Regulatory, Research, and Department (R&D) Staff who will design clinical trial programs
• Physician investigators
• Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs), Data Managers or others working in biomedical product development and/or interested in transitioning into clinical trials field
• Grant Administrators
• Regulatory Affairs
• Quality Control(QC), Quality Assurance Specialists
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