Clinical trial quality ultimately rests on having a well-articulated investigational plan with clearly defined objectives and associated outcome measures. Quality-by Design (QbD) emphasizes building quality into a process from the beginning, and has been successfully utilized in the manufacturing arena. Applied in clinical development, this approach examines the design and objectives of a trial protocol to identify “Critical to Quality (CTQ)” factors (e.g. key data and trial processes). Understanding what aspects of a trial are “critical to quality” is essential to subsequently identifying and managing risks to trial quality.
This seminar will provide attendees with a strong foundation for identifying and managing important risks to quality in the protocol development process.
Attend this 90-minute session, and you will:
- Learn QbD techniques that you can implement immediately to improve trial quality
- Understand Critical to Quality (CTQ) parameters, and build trial protocols that get results
- Mitigate risks and avoid potentially costly pitfalls and rework