Efficient and effective management of clinical trials can significantly impact the time, scope and budget for the development of a drug. Project managers must understand the development process and the key aspects of all phases of Clinical Development in order to act, react and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones to achieving proof of concept for any new drug. Phase 3 clinical trials are critical to gain regulatory approval for the market and Phase 4 allows expansion and extension of the indication for a drug. This course focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations.
The course will discuss the challenges associated with clinical trials run outside the United States and identify key differences, common pitfalls, and cultural differences. Guidance for the how-to as well as problem-solving for specific situations such as slow enrollment, high screen failures, or issues with data quality will be provided. The course is interactive and designed to allow for the exchange of ideas between peers in addition to learning from the instructor.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This course is an overview designed for those in the Pharmaceutical and Biotech industries who will manage or direct projects within their functional area related to Clinical Trials. It will also benefit those who need an understanding of industry specific and project management best practices that should apply to their project. This course also applies for current project managers and others who may have cross-functional project management responsibilities.
Typical Attendees include:
- Project Managers, Directors and Leaders
- Clinical Investigators and Study Coordinators
- Clinical Operations Directors and Senior CRA’s
- Clinical Trial Managers, Monitors and Associates
- Medical Affairs and Clinical Operations Professionals
- Pharmacovigilance and Labeling Professionals
- Physicians and Medical Liaisons
- Regulatory Affairs Professionals
- Preclinical Development Professionals
- Research and Development Scientists
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
Frequently Asked Questions
If I have been managing clinical trials for some time, will this course be redundant for me?
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.
Will this course be useful for someone involved only with veterinary products?
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.
Is the course geared towards a specific therapeutic area?
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.
Are device studies covered in this course?
No, device studies are not covered in detail, just in passing.