Course Description
This 2-day virtual training course provides a practical, execution-focused framework for designing, managing, and overseeing integrated trials, with emphasis on risk identification, cross-functional coordination, monitoring strategy, and inspection readiness. Skills are reinforced through a combination of activities, including case-based learning, interactive exercises, and scenario simulations.
Course at a Glance
2-Day Live Virtual Workshop
2 Full Days of Interactive Learning
Intensive, instructor-led sessions
June 13-14,2026
Upcoming Virtual Workhop
9:00 AM - 4:00 PM EST
Small-group, live instructor-led sessions
Price : $1995.00 USD
Location:
Participate from anywhere with stable internet
Certificate of Completion from CRTA
Recognized professional credential
Faculty Director: Sonja Cooper
Limited Seats - Secure Your Spot Early!
Learning Objectives
By the end of this course, participants will be able to:
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Identify key operational risks unique to integrated drug–device trials
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Align regulatory strategy with clinical operations execution
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Design protocols that are operationally feasible and scalable
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Implement risk-based monitoring strategies tailored to integrated trials
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Apply RBQM principles using KRIs, QTLs, and centralized monitoring
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Strengthen site performance and recruitment strategies
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Prepare for regulatory inspections with confidence
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Build sustainable, repeatable operational models across trials
Who Should Attend
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Clinical Operations Leaders (Manager–Director level)
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RBQM / Central Monitoring Leaders
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Clinical Study Leads / Program Managers
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Data Management & Biostatistics Professionals
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Regulatory Affairs & Quality Professionals
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Device / Digital Health Clinical Teams
Course Outline
Day 1 – Understanding Complexity & Failure Points
- •Key differences vs traditional trials
- •Early-stage failure points
- •Hidden cross-functional dependencies
Session 2: Regulatory Strategy & Operational Impact
- •FDA and Health Canada frameworks
- •IND, IDE, CTA, ITA implications
- •How regulatory decisions impact timelines and execution
Session 3: Protocol Design for Execution
- •Drug + device + software alignment
- •Human factors and usability considerations
- •Version control and amendment management
- •Endpoint complexity
Session 4: Feasibility & Site Strategy
- •Site capability vs experience
- •Training and device readiness
- •Recruitment challenges (including rare disease considerations)
- •Site burden and feasibility risks
Day 2 – Execution, Monitoring, Quality, and Inspection Readiness
- •Aligning Clinical Ops, Engineering, Regulatory, QA
- •Vendor ecosystem management
- •Communication strategies
Session 6: Monitoring & Oversight
- •Device accountability and traceability
- •Training verification
- •Software-related deviations
- •Risk-based monitoring strategies
Session 7: RBQM & Centralized Monitoring
- •KRIs, QTLs, and signal detection
- •Data sources beyond EDC
- •Integrated risk-based monitoring models
Session 8: Quality & Risk Management
- •CAPA and change management
- •Documentation challenges
- •Risk lifecycle management
Session 9: Inspection Readiness
- •Common regulatory findings
- •Red flags during inspection
- •Bridging gaps between operations and regulatory expectations
Session 10: Sustainable Operating Models
- •Standardization across trials
- •Process scalability
- •Continuous improvement of frameworks
Interactive Components
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“What Breaks First?” Risk Identification Exercise
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Protocol Risk Assessment Workshop
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Cross-Functional Conflict Simulation
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“Fix the Broken Trial” Capstone Case Study
Course Deliverables
Participants will receive:
- •Integrated Trial Risk Assessment Framework
- •Monitoring Strategy Template (Drug + Device)
- •Site Capability Assessment Tool
- •RBQM Implementation Guide
- •Inspection Readiness Checklist
Evaluation & Completion
- •Knowledge check (interactive quiz)
- •Participation in exercises and discussions
- •Capstone scenario performance
Key Takeaways
Participants will leave with:
- •A clear operational framework for integrated trials
- •Practical tools for immediate application
- •Enhanced ability to identify and mitigate risks early
- •Strategies to improve monitoring quality and site performance
- •Confidence in supporting inspection readiness and regulatory success
