Strategic Clinical Research Operational Planning: Applied Techniques for Cost Estimation, Risk Management, and Quality Assurance

This course is an integrative learning experience, combining a comprehensive review of the Good Clinical Practice core principles and project management strategies applicable to clinical research during the new drug development process. We will examine the concepts and applied techniques for cost estimation (PERT analysis, bottom-up, top-down, etc.), risk management, and quality assurance. We will focus on the principles and methodology of planning, controlling, and coordinating individual and group efforts. Key topics include organization strategy and project selection, developing a project plan, scheduling resources, project risk analysis, work breakdown structures, and project networks. Mastery of key tools and concepts introduced in this course and development of the skills vital to effective management of multidisciplinary tasks will provide clinical research professionals a significant competitive advantage in the marketplace.

• Apply a new understanding of infrastructure and clinical operations in industry and clinical sites
• Develop skills for strategic planning of clinical trials
• Perform cost estimation and develop a schedule
• Establish systems for quality control and monitoring of clinical trials
• Identify resources needed to complete projects
• Assign roles and responsibilities for a clinical trial and develop a communication plan
• Identify, manage, and mitigate risks of clinical trials

• New Project Managers and Team Leaders with little or no drug development or clinical trial experience who will be managing drug development programs and supervising Project Managers
• New Clinical, Regulatory, and Department Staff who will design clinical trial programs
• Clinical Research Associates
• Data Managers

The course will be led by one of the following instructors:

Marina Malikova, Ph.D., M.S., M.A., C.C.R.A.

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Day 1: 8:30 a.m. – 5:00 p.m.

• Overviewof Operational Planning: Charter; scope; work breakdown structure (WBS) and the network
• Strategic Planning in Clinical Research: Projections of expenditures and milestones; estimation of risks
• Contractors – Managing Outsourcing: Selection; scope; standards and expectations
• Project Communications Plan: Team building; conflict resolution; virtual teams; reporting and communications
• Timeline Management: Schedules and milestones completion; scope change
• Project Cost Estimation: PERT analysis, bottom-up and top-down cost estimation techniques

Day 2: 8:30 a.m. – 5:00 p.m.

• Development and Management of Project Budgets: Cost estimation techniques; ongoing financial management and costs monitoring
• Project Tracking: Tracking requirements; identifying and establishing project metrics
• Project Progress Monitoring Tools: Earned value; actual versus planned costs; schedule and cost; performance index
• Risk Management and Implementation of Strategic Project Management Concepts in Clinical Trials: Risk mitigation strategies; schedule; cost and change
  management
• Quality by Design (QbD) Principles and Risk-Based Monitoring: Applying a risk-based management approach in development of relevant Key Performance and Quality Indicators (KP-QIs)
• Close Out Phase: Plan and process; study documentation and record retention; laboratory records and specimen retention; study participant rights and notifications

• Identify Project Issues/Risks
• Perform Cause-Effect Analysis and Develop a Risk Management Strategy
• Develop Preliminary Quality by Design (QbD) Strategy and Apply Quality Risk Management (QRM) Perspective to Develop Baseline Quality Metrics and Key Risk Indicators
• Perform Cost Estimation and Establish Clinical Research Study Schedules

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-15-038-L01-P. Released 3/15.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.