Breakout 2: When Systems Fail, Oversight Speaks Loudest
Data Under Pressure – Integrity and Systems in the R3 EraR3 has sharpened expectations for data integrity, traceability, and system validation. This session digs into the real-world challenges of ensuring data reliability across increasingly digital and outsourced environments.
Facilitator: Kieran Canisius
Bio
Kieran helps biotech and pharma sponsors bring clarity and structure to vendor relationships that directly impact clinical delivery. She specializes in aligning outsourced partners with trial goals, protecting budgets, timelines, and decision-making momentum.
She brings over a decade of experience negotiating clinical development contracts ranging from $2 million to $150 million, with a focus on bringing structure and clarity to high-stakes engagements.
Discussion Subtopics
- Defining “data integrity” beyond ALCOA+: what regulators are really looking for.
- Risk-based approaches to system selection, validation, and ongoing monitoring.
- Cloud systems, eTMF, and decentralized trials: where risk escalates.
- Practical examples of data oversight failures and how to prevent them.
Under R3, Your Systems Tell a Story. Make Sure It’s the Right One
ICH E6(R3) challenges sponsors to move beyond generic system documentation and toward a real-time, risk-based understanding of where data integrity can break down, especially across complex digital and outsourced environments.
During the in-person session at Syncup, participants were given real-world data integrity failure scenarios, from broken data flow diagrams to missing computer system validation (CSV), and tasked with identifying what went wrong, what R3 requires, and what should have been done differently.
Scenarios Explored
1. Incomplete Data Flow Diagram
A sponsor submitted a protocol with a data flow diagram, only to receive feedback from regulators that it lacked sufficient system detail.
What went wrong: The diagram focused on operational flow, not on which systems were used, how data moved, or how integrity was protected.
What should have happened: Sponsors should show full system interactions, identify risk points, and clarify roles, especially for manual processes and dual-entry risks.
2. Insufficient Controls Beyond a Diagram
Another sponsor submitted a clean-looking diagram, but failed an audit due to lack of implementation steps.
What went wrong: A diagram alone is not enoughm it must be supported by controls.
What should have happened: Teams should inventory systems, conduct risk assessments, and plan for validation and lifecycle oversight. Diagrams should illustrate a governance strategy, not replace one.
3. Unvalidated Technology System (CSV)
A sponsor contracted a vendor for a digital endpoint system, but mid-study realized it had never been validated. The study was cancelled.
What went wrong: The sponsor failed to validate the system or vendor up front.
What should have happened: Qualification, reviewed documentation, inclusion in the validation master plan, UAT testing, and vendor audits—all documented, should have been done before the system was implemented.
What the Session Made Clear
Sponsors often assume vendors or systems “have it handled”, but under ICH E6(R3), assumptions won’t hold up in an inspection. The session reinforced the importance of:
- Aligning data integrity controls with actual systems, not just process maps
- Ensuring CSV is documented, traceable, and vendor-inclusive
- Mapping where data travels, how it transforms, and who is responsible at each point
- Replacing cosmetic compliance with fit-for-purpose system validation and oversight
Data integrity isn’t just a documentation exercise, it’s a systems and accountability issue. If your team needs help translating R3 expectations into tangible, auditable system and vendor strategies, Seuss+ can help.
Did You Miss a Conversation? Catch Up On Session All Breakouts Here
Breakout 1
Different Maps, Same Destination: Interpreting Oversight Under R3
Breakout 2
Data Under Pressure – Integrity and Systems in the R3 Era
Breakout 3
Using Proportional Risk to remain “Small but Mighty”
Breakout 4
Ready or Not – Inspection Readiness under R3
When Systems Fail, Oversight Speaks Loudest
ICH E6(R3) raises the bar on data integrity, but it also gives sponsors the structure to meet it. Whether you’re diagramming data flows, managing third-party tech vendors, or validating digital tools, your systems must demonstrate not just functionality, but fitness for purpose.
Seuss+ helps biotech sponsors align oversight, documentation, and system validation with evolving R3 expectations, without unnecessary complexity.