CYNTEGRITY LEADERSHIP ROUNDTABLE Q4 2026
THE DECISION ROOM
Can You Prove It Changed the Study?
An invitation-only, one-day leadership simulation for
senior clinical trial leaders with direct responsibility
for Risk-Based Quality Management.
Thursday, 12 November 2026
Frankfurt, Germany
A Trial Under Pressure
Most organizations can produce a risk assessment. The more difficult question is whether they can demonstrate how that assessment influenced study conduct.
A fictional but realistic Phase III study provides the common evidence environment. Over three simulation rounds, new information enters the room, and participants must decide what it means, what should change, and how their rationale should be documented.
There is no single predetermined answer. The Decision Room tests whether decisions are proportionate, accountable, and defensible.
INTERPRET THE SIGNAL
What further evidence is needed? Who owns the decision? What should deliberately not be escalated?
DETERMINE THE INTERVENTION
What evidence informed the decision? Why was this action chosen? What outcome is expected, and how will it be evaluated?
DEFEND THE DECISION
Can we prove the response was proportionate, traceable, and protective of participants and critical trial outcomes?
What to Expect on 12 November
Previous Leadership Roundtable Faculty
The following leaders contributed to our previous Leadership Roundtable.
They are presented to illustrate the calibre and cross-functional perspective of the community developed through earlier Cyntegrity events. Participation in The Decision Room 2026 is not implied. The 2026 faculty will be announced separately.
“Leaders who build inspection-ready trials don’t gamble on quality – they engineer it.”
A Working Room for Those Accountable
For leaders who must interpret signals, determine proportionate action, and defend the rationale behind study oversight decisions.
When the evidence changes, can your decision still stand?
© 2026 Cyntegrity – RBQM operating model for traceable trial oversight.
