Course Description
This hands-on, operations-focused course is designed to equip clinical research professionals with the practical tools, strategies, and decision-making frameworks needed to successfully plan, manage, and execute integrated drug–device trials. While key FDA and Health Canada regulatory concepts are covered, the emphasis is on real-world trial operations, risk management, and execution strategies, not regulatory theory.
Participants will explore how integrated trials differ from standalone drug or device studies, where teams commonly fail, how regulators think about these studies, and how to proactively mitigate risks.
Special Feature: Expert panel on FDA & Health Canada device submissions (45–60 min)
Course at a Glance
2-Day Live In-Person Workshop
2 Full Days of Classroom-based learning
Intensive, instructor-led sessions
May 23 & May 30, 2026
Upcoming Classroom Workshop
9:00 AM - 4:00 PM EST
Small-group, live instructor-led sessions
Price : $1995.00 USD
Location:
Lionhead Golf Mississauga Road – Ontario
Certificate of Completion from CRTA
Recognized professional credential
Included Perks:
Complimentary Lunches & Coffee breaks
Faculty Director: Luana Torres
Limited Seats - Secure Your Spot Early!
Learning Objectives
By the end of this course, participants will be able to:
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Distinguish integrated drug–device trials from drug-only and device-only clinical trials from an operational and management perspective
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Identify early strategic decisions that impact regulatory pathway selection, trial design, and operational complexity
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Understand how FDA and Health Canada regulate combination products and how those frameworks influence trial execution
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Design operationally feasible study plans that account for device lifecycle, software updates, and investigational drug supply
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Anticipate common regulatory, operational, and quality pitfalls in integrated trials
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Manage cross-functional teams spanning clinical, regulatory, engineering, quality, and manufacturing
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Develop monitoring, risk management, and vendor oversight strategies specific to integrated trials
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Apply best practices for documentation, data integrity, and inspection readiness
Who Should Attend
This course is ideal for professionals involved in planning, managing, or overseeing integrated clinical trials, including:
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Clinical Operations Managers and Directors
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Clinical Trial Managers and Project Managers
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Clinical Research Associates (CRAs) and Lead Monitors
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Biotech and MedTech professionals transitioning into combination product trials
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Quality, Compliance, and Risk Management professionals
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Startups and scale-ups professionals running early to mid-phase integrated trials
Prerequisite: Basic understanding of clinical trial conduct, basic regulatory understanding and good GCP-level knowledge.
Course Outline
Day 1 – Strategy, Design, and Operational Foundations
Module 1: Introduction to Integrated Drug–Device Trials (Why These Trials Are Different—and Harder)
- •What defines an integrated drug–device clinical trial
- •Common scenarios: drug + delivery device, drug + diagnostic, SaMD + therapeutic
- •Key differences - drug-only and device-only trials
- •Why operational failures often occur early
Interactive Activity: Group discussion: "What would break first?" — identifying early operational weak points
Module 2: Regulatory Landscape—What Operations Teams Need to Know (FDA & Health Canada – practical, not theoretical)
- •Overview of FDA combination product framework
- •Health Canada approach to combination products
- •Who is the "lead" regulator, and why does it matter operationally
- •IND, IDE, CTA, ITA – what operations teams must track
- •How regulatory pathway decisions impact timelines, monitoring, and documentation
Module 3: Trial Design & Protocol Considerations for Integrated Studies (Highly applied – less theory, more execution)
- •Designing protocols that align drug and device development timelines
- •Device usability, training, and human factors considerations
- •Software updates, version control, and protocol amendments
- •Managing endpoints tied to both drug efficacy and device performance
- •Site burden and feasibility considerations
Interactive Activity: Protocol risk assessment: identifying design elements that increase operational complexity
Module 4: Operational Planning & Cross-Functional Execution
- •Aligning clinical operations, engineering, regulatory, and quality teams
- •Managing investigational product supply (drug + device)
- •Site selection and activation challenges unique to integrated trials
- •Vendor oversight: CROs, device manufacturers, software vendors
- •Communication strategies to avoid siloed execution
Scenario-Based Activity: Cross-functional conflict simulation and resolution strategies
Day 2 – Execution, Oversight, and Regulatory Reality
Module 5: Monitoring & Oversight in Integrated Drug–Device Trials
- •How monitoring differs from drug-only trials
- •Device accountability, traceability, and training verification
- •Monitoring device performance and software-related deviations
- •Data integrity risks unique to integrated trials
- •Red flags CRAs and study teams must escalate early
- •Risk-based monitoring strategies for integrated studies
Module 6: Quality, Risk Management, and Inspection Readiness
- •Common inspection findings in integrated trials
- •Documentation pitfalls
- •Change management and CAPA considerations
- •Preparing for FDA and Health Canada inspections – Operations focused
- •Inspection readiness as an ongoing operational process
Module 7: Discussion Panel – Regulatory Pitfalls & Red Flags (45–60 minutes)
Panel Focus Areas:
- •Most common FDA and Health Canada submission pitfalls
- •Red flags regulators notice immediately
- •Gaps between clinical operations and regulatory expectations
- •Lessons learned from real submissions
- •How operations teams can proactively prevent regulatory delays
Live Q&A
Module 8: Closing Session – Knowledge Check & Integration
- •Interactive quiz covering key concepts from both days
- •Group reflection: "What will you do differently on your next trial?"
- •Practical takeaways and tools for immediate application
- •Open Q&A
Interactive Activities (Summary)
Throughout the course, participants will engage in:
•Case-based discussions using real-world trial scenarios
•Protocol and operational risk assessments
•Monitoring simulations and red flag identification
•Cross-functional problem-solving exercises
•Live panel Q&A
•Interactive knowledge quiz and applied discussion
