Protocol Development & Study Design
Design robust, regulatory-ready clinical trial protocols
LEVELS
Training Levels
Choose the right level for your team
Protocol Immersion
LEVEL 1New staff, residents entering clinical research
- Anatomy of a protocol
- Defining the research question (PICO)
- Setting objectives
- Basic endpoint selection
Advanced Protocol Design
LEVEL 2Experienced PIs
- Complex methodologies
- Adaptive trial designs
- Statistical power calculations
- Handling protocol deviations
Protocol Strategy
LEVEL 3Senior PIs, research directors
- Portfolio management
- Competitive landscape analysis
- Funding acquisition strategies
- High-level design leadership
OUTCOMES
Learning Outcomes
Design robust protocols with statistical power and scientific rigor
Reduce protocol amendments by identifying bottlenecks early
Structure protocols to meet SFDA and IRB/EC requirements
Optimize inclusion/exclusion criteria for successful recruitment
Ensure designs align with institutional research goals
AVAILABILITY
Training Formats
On-Site Training (KSA)
CERTIFICATE INCLUDED
Virtual Classroom
CERTIFICATE INCLUDED
Europe Immersion
CERTIFICATE INCLUDED
All participants receive an MFG Training certified completion certificate upon successful program completion.
Key Topics
Key Topics
- 1Protocol Anatomy, Defining PICO, & Endpoint Selection
- 2Complex Methodologies & Adaptive Trial Designs
- 3Statistical Power Calculations & Handling Protocol Deviations
- 4Portfolio Management & Funding Acquisition Strategies
Not Sure Where to Start?
Assess your team's experience levels and exact training needs with a customized consultation.
- Level Recommendations
- Customized Proposals
- Flexible Scheduling