Mastering Cost Management for Global Clinical Trials

This course builds on basic, intermediate, and advanced project management concepts to examine some of the most difficult issues encountered in domestic and global clinical trials. This workshop focuses on cost management, the most challenging factor of any drug development project as per the theory of triple constraints. Trials conducted outside the United Stated present additional challenges such as language, cultural differences, variations in medical practices, and much more. They can, however, significantly contribute to keeping the cost/budget estimates in line with the desired target. This course is presented in a dynamic, interactive manner to facilitate learning and retention.

• Master cost, time, and people issues through advanced project management tools
• Ensure the success of your teams by developing effective communication skills and mastering relationships within project teams
• Master the financial concepts and tools required for high performance trials
• Communicate with financial staff and get what you need
• Design a performance environment that motivates all through clear expectations and consequences
• Manage operational challenges in patient recruitment and retention
• Strategically manage CROs and other partner projects to achieve substantial cost performance
• Lead a cross-cultural team by positive influence
• Plan for contingency, but more importantly, take preventive actions on potential risks to avoid common cost and financial pitfalls
• Take advantage of emerging countries and Asia for maximum cost effectiveness, and get up-to-date cost data for these regions

• Project Managers, Directors, and Leaders
• Financial Staff and Managers
• Clinical Research Investigators, Coordinators, Associates, Monitors, and Managers
• Regulatory, Medical, and Clinical Affairs Professionals
• Preclinical and R&D Directors/Associates/Scientists
• Toxicology, Pharmacology, Pharmacovigilance, and Labeling Professionals

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

Eric Morfin, M.B.A., P.M.P

Click here for complete trainer biographies

Day 1: 8:30 a.m. – 5:00 p.m.

• “Stage Gates,” Product Profiles, and Budget Management: “Stage Gate” process for optimal portfolio and budget management; relationship between the minimum Target Product Profile (TPP) and the overall project cost
• Developing a Budget for Meeting Project Objectives: Frequently overlooked costs; timelines; critical path; Gantt chart; external and outsourcing costs; impact of FDA review process on the budget
• Projects and Project Management within a Financial Context: Financial and business drivers behind projects; financial quantification of project benefits and payback
• Working with Finance Staff to Assess and Plan Project Funding Options
• Financial Planning for Projects and Outsourcing
• Budget Versus Cost Management
• Potential Problem Analysis for More Accurate Financial Planning: Identifying and prioritizing risks and their causes; developing preventive and contingent actions

Day 2: 8:30 a.m. – 5:00 p.m.

• The Need for Financial Planning and Management: Accounting and financial concepts and terminology; an executive summary of project financial critical factors
• Define Outsourcing Strategies: Transactional through alliance approaches; functional versus full service sourcing; cost and contract management; managing costs with overseas trials; leveraging emerging markets for cost performance
• Clinical Operations Performance Review: Impact of investigators, sites, and other parameters on your cost estimate
• Portfolio Management
• Managing Change and Mastering Change Management
• Project Implementation, Monitoring, and Control
• Making Rationale Budget Decisions to Avoid Costly Mistakes
• Best Practices for Budget Negotiation: Adapting to cultural differences; top down versus bottom up; frequently overlooked costs
• Improving R&D Productivity by Capitalizing on Characteristics Unique to Asia: Most recent costs data on clinical trials in Asia; managing outsourced service providers in Asia

• Identify the potential financial risks related to a global trial and select the best set of preventive and contingent actions
• Select the best package for the international launch of a once daily pill
• Assess the impact of cultural biases on the financial assessment and performance of the clinical trials you manage

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 Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.

Click here for our seminar cancellation policy

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 mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-12-007-L01-P. Released: 5/12.

Hold this course at your company!

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