Clinical Trial Project Management, Phase 1-4 Best Practices

The course provides a thorough understanding of the activities involved during all Clinical Phase of Drug Development. The intent is to provide detailed knowledge of the project management practices, skills and tools that will make the difference between a successful clinical trial and one that does not meet its goals.

By the end of the course, participants should be able to do the following:

• Understand the overall drug development process and the unique aspects of Phase 0 through Phase 4
• Apply project management best practices to clinical trials
• Manage a development project team and recognize team needs and leadership skills required for different stages of the drug development process
• Refine the target product profile and position the drug for future submission, approval and launch
• Understand GCP guidelines, FDA, EMA regulations and ICH guidelines
• Understand and manage the challenges of clinical trials outside the USA
• Develop accurate clinical trial timelines and budgets
• Achieve high quality clinical data and optimize study logistics
• Manage clinical supplies in your project plan
• Manage adverse event reporting and protocol deviations
• Prevent and manage fraud and study misconduct

Drug Development and Project Management

• Overview of the Drug Development Process
• The History of Project Management

Overview of Clinical Phases – What are they?

• Phase 0 or Exploratory INDs
• Phase 1
• Phase 2 (a/b)
• Phase 3 (a/b)
• Phase 4
• Investigator Sponsored Studies

Clinical Development Tools

• Target Product Profile (TPP)
• Clinical Development Plan (CDP)
• Protocol templates
• Clinical Plan (CP)
• Core Data Sheet or MIRS (Messages, Issues, Responses, Supporting Documentation)

Regulations Governing Clinical Research

• Brief History of the FDA

Regulations Governing Clinical Research (cont'd)

• FDA, EMA, MHAA
• Good Clinical Practice (GCP)
• International Conference on Harmonization (ICH)
• Who is responsible? Sponsor, Monitor, Investigator

Ethics and Warning Letters

• What they tell you and how can you apply those lessons?

Study Conduct

• Timelines
• Budgets
• Risk Assessment
• CROs and Outsourcing

GlobalTrials

• Working in China and India
• Working in the Developing World
• Common Issues to address – Culture, Language, Time Zone

Life Cycle Management

• Keeping your Drug Portfolio alive
• Extending Patent Life
• Line Extensions, Re-Purposing, Re-Branding
• Fraud and Misconduct

Team Conduct

• High Performing Teams
• Team Roles and Responsibilities
• Communication, Negotiation & Conflict
• Team Dynamics and Leadership

“This course introduced a lot of new information for me. I found the instructor very knowledgeable and experienced in this area. I found the exercises and activities useful. So much of this was new to me. I learned a great deal about another side of the business."

Lynne M., Senior Validation Specialist, bioMérieux

"Course was effective and informative. The course director was excellent, a dynamic speaker and was able to engage everyone in the group."

Carolyn B., Senior Manager, R&D QA, Incyte

"The Course Director is highly knowledgeable and very skilled in teaching and getting all participants involved. The course is illustrated with many practical anecdotes of real life experiences in the pharma world. The course also includes exercises that are very instructive. This three day course was really worthwhile."

Hamidou T., Project Manager, SMB

"The course was exceedingly useful because of the interpersonal relationship of projects we have been involved with. I would recommend this course to others. It provides the "language" (the proper lingo) to articulate the management of clinical studies."

Barrie T., President, American River Nutrition

"Excellent course – learned a lot, interesting examples of points. Break our sessions were really good – lots of interaction. A number of the topics I had not considered but the course presented these topics as applicable to my own business and would time/budget saving if implemented. Good ideas, excellent networking opportunity!"

Dianne W., Clinical Research Associate

"Course Director was well organized and an effective speaker. I would certainly consider taking other courses from CfPIE and this Course Director"

Danielle C., Regulatory Scientist, Merck

"It was fun, informative, and challenging. I will suggest to my peers to attend this course since it can be applied at any level of pharma."

Gard W., Consultant, Nova Safety Consulting

"Absolutely excellent! I got far more information out of this course than I anticipated! Great speaker, great content!"

Sandy H., President, Inspiring Minds Inc.

Not necessarily. It could be viewed as a refresher. A wide variety of topics are covered, from managing time, scope and budget of a trial to the regulations for trials in the US, EU and Japan as well as team skills to manage staff involved in your trial. Every company manages studies differently, so there is a great deal to learn from participants as well as the instructor.

Although the process of approval for new animal drugs is similar to human, there are enough differences that this course may not be useful if someone is involved only with veterinary products.

The clinical trial management information is not specific for any therapeutic are, but can be utilized for all areas, in general. Some of the case studies and break-out sessions focus on a specific therapeutic area, but only for learning purposes.

No, device studies are not covered in detail, just in passing.