This course provides attendees with the skills they need to lead their domestic and global clinical trials to optimal performance. Building on basic and intermediate project management concepts, this course provides the experienced clinical professional with tactical information to overcome the most difficult issues encountered. Advanced concepts will be presented, including performance and time management, delay tracking and prevention, ensuring adequate regional patient supply and enrollment interest before beginning a trial, strategies when enrollment is not progressing, and ensuring high quality data on a global scale. Advanced concepts around root cause analysis and corrective and preventive action are also presented. It is likely that the experienced project manager is working in a global environment, and this course provides best practices for managing international trials and international outsourced service providers. All concepts are presented in a dynamic, interactive manner to facilitate learning and retention.
- Master quality and timeline tracking and monitoring, and track and prevent delays
- Navigate ever-changing international regulations
- Strategically approach negotiations in light of global cultural, language, and healthcare differences
- Ensure high quality data results from your global clinical trial
- Employ best practices for managing global outsourced providers
- Identify and prioritize potential problems, and implement root cause analysis and corrective and preventive action plans
- Design a GCP and SOP Compliant Project Operating Guideline (POG) for High Performance Clinical Trials
- Employ effective communication within project teams
- Design a performance environment that motivates all through clear expectations and consequences
- Manage operational challenges in patient recruitment and retention
- Project Managers, Directors, and Leaders
- 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.
- Introduction: Pressures from a changing environment; fundamental components for success; key decision points; trends
- Performance Management and Site Management: Quality and timeline tracking and monitoring; team and sub-team roles and responsibilities; stakeholder communication plan
- Advanced Time Management: Delay tracking and prevention; timeline management core concepts; tracking progress against objectives and the use of milestones; strategies for accelerating clinical trial timelines
- Global Clinical Regulations: International regulatory bodies and changing regulations; HIPAA and international informed consent and privacy regulations; the European Clinical Trial Directive
- Global Clinical Trials: Cultural, language, and ethical issues; variations in practice conventions and health care services; logistics
- Global Investigator and Patient Recruitment Strategy: Country specific regulations; locating and retaining qualified investigators; ensuring adequate regional patient supply and enrollment interest before beginning trial; enrollment targets and timelines; advertising campaigns and dollars; centralized recruiting services; newsletters; tracking enrollment; strategies when enrollment is not progressing
- Ensuring High Quality Data Results from Clinical Trials: Data management logistics; methods of getting paper to and from the sites; Electronic Data Capture (EDC); adverse event reporting on a global scale
Day 2: 8:30 a.m. – 5:00 p.m.
- Misconceptions About Managing Trials in Asia: Each country was not created equally: how to select the right international collaboration
- Best Practices for Managing Outsourced Service Providers: Key concepts for managing outsourcing projects; preparing for implementation of an outsourced relationship; implementing controls; risk management; transition; close-out
- Preventing Potential Problems: Identifying, prioritize, and prevent potential problems; develop preventive and contingent actions
- Decision-Making and Troubleshooting: Specifying the decision framework; agreeing and negotiating objectives; selecting and evaluating alternatives; root cause analysis (RCA); corrective and preventive action (CAPA)
- Designing a GCP and SOP Compliant Project Operating Guideline (POG) for High Performance Clinical Trials
- Negotiation Skills Across Cultural Barriers
- Select the best package for the international launch of a once daily pill
- Quickly identify the root cause of a disfigured pill launched in several countries
- Identify the potential risks related to a global trial and select the best set of preventive and contingent actions
- Learn to quickly assess the leadership style required by each situation
- Gain a better understanding of your cultural biases and how they impact the 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 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 mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-005-L01-P. Released: 2/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.