FlowTrial

Sponsor Oversight Monitor/Manager Training Course — FlowTrial
Professional Training Course

Sponsor Oversight
Monitor / Manager
Training Course

Regulators expect documented, demonstrable sponsor oversight. Most guidance tells you what — not how. This course gives you the framework, the tools, and the AI Copilot to do it right.

📅
Small cohort — dates announced once enrolment opens
🕠
2 sessions of 2.5h each
💻
Live on Zoom
📋
~1h homework between sessions
Sponsor oversight isn't optional anymore — this course shows you exactly how to do it.

What you'll walk away with

Draft plans & framework blueprints
Editable starting points you can tailor to your trial — not generic templates.
Regulatory clarity
ICH E6(R3), FDA, EMA and MHRA expectations decoded into practical actions.
Study-level perspective
From site task-checking to quality-by-design — you'll see the full picture.
Real case studies
Drawn from inspection trends. Know what regulators actually flag.
Stronger communication
Clearer conversations with CRAs, CROs, and internal teams about sponsor oversight.
Certificate of Completion
Awarded after plan submission + quiz. Ready for your CV and LinkedIn.

You won't just learn sponsor oversight — you'll build it

📄

Your Own Sponsor Oversight Plan

Between sessions, you'll draft a real Sponsor Oversight Plan for a study of your choice. You'll use the Sponsor Oversight Copilot AI chatbot to generate context-specific content, refine your risk approach, and stress-test your thinking. By the end of Day 2, you'll have a document you can actually use — not just a course notebook.

Two-day agenda

Day 1 Foundations of Modern Sponsor Oversight
17:30
Why we're here — expectations & success criteria
17:45
What regulations really expect — ICH E6(R3), FDA, EMA
18:20
Sponsor Oversight myths vs. reality
18:30
Break
18:40
The Sponsor Oversight Mindset & the Monitor/Manager Role
19:00
AI in Sponsor Oversight — Part I: Introduction & tools
19:20
Case Studies Part I + AI Copilot practice
20:00
Closing — end of Day 1
Day 2 From Theory to Execution
17:30
Recap & warm-up
17:45
Planning & conducting a Sponsor Oversight Visit
18:25
Sponsor Oversight documentation — purpose, structure, templates
18:40
Break
18:55
AI in Sponsor Oversight — Part II: Advanced prompting
19:15
Workshop: build your Sponsor Oversight Plan + Q&A
19:50
Clarifications, follow-up & next steps
20:00
Closing — end of course

Your Sponsor Oversight Copilot

🤖

GPT-powered AI chatbot — built for this course

The Sponsor Oversight Copilot is a custom AI assistant trained on sponsor oversight frameworks, regulatory expectations, and the course content. During the workshop you'll use it to draft your plan, generate risk assessments, and get instant answers to sponsor oversight questions. You keep access after the course — so it stays useful long after certification.

About FlowTrial

FlowTrial is a European clinical research consulting and training company helping sponsors, CROs, and individual professionals build real, consistently documented sponsor oversight. Every sponsor oversees their trials in some way — the gap is rarely the oversight itself, but the lack of a consistent log, template, and method behind it. Founded by Smaranda Doucet, FlowTrial's mission is to turn fragmented regulatory expectations into practical, repeatable frameworks teams can actually run with.

Who this course is for

CRAs & Lead CRAs growing into sponsor oversight
CTMs, PMs, Clinical Ops Directors
QA / Compliance professionals
Sponsors outsourcing to CROs
Consultants building sponsor oversight services
Runs the same whether you oversee 3 sites or 200

No prior sponsor oversight experience required. A background in PM, QA, or CRA work is sufficient.

How the course runs

Format details

🕠
Time
2 × 2.5h live sessions (evening-friendly, CET)
💻
Platform
Live on Zoom
📋
Homework
~1h between sessions to draft your Sponsor Oversight Plan
🔒
Confidentiality
All participants sign a mutual CDA — your Sponsor Oversight Plan and any study details stay private
🎥
Recordings
Live attendance is encouraged for the workshop exercises; reach out if a session conflicts with your schedule
👥
Group delivery
Available for associations, teams & in-house — get in touch to arrange a dedicated cohort
📬

Small cohort, opening soon

Dates aren't fixed yet. Registering your interest costs nothing and commits you to nothing — but it means you'll be first to know when the cohort opens, and considered for early enrolment pricing.

Common questions

No — this is practical training. For legal interpretation, consult your QA, RA, or Legal team.
Live attendance is part of the design — the workshop exercises are interactive. Let us know in advance if a date conflicts and we'll do our best to accommodate.
Yes. All participants sign a mutual CDA, and any study details you bring into the workshop stay private.
Yes — the same framework applies whether you're overseeing a small device trial or a large multi-country Phase III.
No. A background in PM, QA, or CRA work is enough to benefit fully from this course.
A custom GPT-powered chatbot pre-loaded with sponsor oversight frameworks and course content — yours to keep after the course.

About Smaranda Doucet

SD

Smaranda Doucet

Founder, FlowTrial · Sponsor Oversight Educator · Speaker · Clinical Research Expert

After 19 years across Romania, Spain, France, the UK, and the US — as a CRA, a CRO founder, and a sponsor-side operations leader — Smaranda has assessed 100+ investigator sites across five countries, built and run a CRO, and led sponsor oversight on sponsor-facing trials. She operates in four languages.

Her perspective: issues are signals, and patterns are the real information. The professionals who can read those patterns are the ones who prevent problems instead of just documenting them. This is the lens she brings to sponsor oversight education — turning fragmented regulatory expectations into logical, practical frameworks that sponsors can actually use.

She recently spoke at CRA Connect in Barcelona on how shifting from issue-focused to pattern-focused thinking transforms clinical trial delivery. FlowTrial is her European platform for sponsor oversight consulting and training in Phase II–III studies.

smaranda.doucet@flowtrial.net · flowtrial.net

Join the Waiting List

Interested in the next cohort?

Dates aren't confirmed yet. To register your interest — at no cost and with no commitment — simply send an email to:

Please include in your email:

  • Your full name
  • Your current role
  • Your organisation

You will be personally contacted as soon as the next cohort dates are confirmed — and considered for early enrolment pricing.