Safeguarding Data Integrity in a Phase 2 COPD Study
Summary
A privately owned clinical-stage biotech developing treatments for respiratory conditions was conducting a Phase 2 COPD study with support from a large CRO and six directly contracted vendors.
The sponsor lacked clarity on the computerized systems being used across the trial. The CRO had not provided an electronic data flow diagram or the validation documentation needed to confirm that the systems were fit for purpose within the context of the study.
This created concern about meeting EMA, FDA, and ICH-GCP expectations, while also limiting the sponsor’s oversight of trial data integrity.
Seuss+ completed a Clinical Systems Analysis across the CRO and six directly contracted vendors. The work mapped the electronic data flow, identified risks to data integrity, and set out practical actions to strengthen sponsor control and support compliance.
What Seuss+ Delivered
Clinical Systems Analysis, Data Flow Mapping and Compliance Recommendations
Seuss+ carried out a Clinical Systems Analysis covering the computerized systems used by the CRO and six other vendors contracted directly by the sponsor.
The analysis produced a complete electronic data flow diagram, giving the sponsor a clear view of how trial data moved across systems and vendors, where manual transfers took place, and where additional controls were needed.
The work also identified risks to data integrity, gaps in validation and archival planning, and an opportunity to improve data flow. The final report documented practical recommendations for safeguarding trial data, strengthening sponsor oversight, and addressing further steps needed to better meet regulatory expectations.
The Risk/Challenge
The sponsor lacked clarity from the large CRO on the computerized systems being used in the Phase 2 trial.
The CRO could not provide an electronic data flow diagram.
Validation documentation had not been supplied.
The sponsor could not confirm that the computerized systems were fit for purpose within the context of the study.
The lack of system and validation information created concern about meeting EMA, FDA, and ICH-GCP expectations.
The sponsor did not feel it had sufficient control over trial data integrity.
Manual data transfers increased the need for additional review and oversight.
The sponsor needed clearer measures for managing system changes and data archival.
The Results
A complete electronic data flow diagram was delivered, allowing the sponsor to address a key regulatory requirement.
Thirteen recommendations were documented: 2 Priority, 6 High, 3 Medium, and 2 Low.
A full list of computerized systems used across the study was created to support the sponsor’s systems inventory.
Fourteen computerized systems were identified as requiring validation follow-up.
Three of those systems were managed through direct contracts, while eleven were managed through the CRO.
A participant ID traceability risk was identified within the CRO’s process, together with possible solutions and next steps.
Risks linked to manual data transfers were documented, with a need for increased sponsor oversight.
Additional controls were recommended for computerized system changes made during the study.
A gap in the archival approach was identified.
The sponsor received a clear set of actions for defining required end-of-study data and documents and selecting a GxP-compliant archival solution.
How We Helped
Reviewed the computerized systems used by the CRO and six directly contracted vendors.
Created a full inventory of the systems supporting the trial.
Mapped the electronic flow of clinical data across systems and vendors.
Identified areas where manual transfer processes increased data integrity risk.
Assessed the availability of system validation documentation.
Identified fourteen systems requiring validation follow-up.
Reviewed participant ID handling and identified a traceability risk.
Defined possible solutions and practical next steps for the traceability issue.
Recommended additional sponsor oversight for system changes during the study.
Identified an archival gap and provided actions for study closeout.
Delivered a report containing thirteen prioritized recommendations to strengthen control and support compliance.
Frequently Asked Questions
The sponsor needed a clear record of how clinical data moved between systems, where it was transformed, and which parties were responsible for each stage. Without this view, it was difficult to assess traceability, validation status, and data integrity controls. Regulators expect a sponsor to be able to describe its own data flow, and an incomplete picture is a finding waiting to happen.
The assessment identified 14 systems requiring validation review, 11 of them managed by the CRO and 3 through direct contracts. It also uncovered a participant ID traceability risk that could have caused inconsistencies between systems, along with gaps in archival planning and manual data transfer points that needed additional sponsor oversight.
Yes. The analysis can be carried out during an active study. Seuss+ works with the sponsor and its vendors to clarify system ownership, assess available documentation, map data flows, and define corrective actions without replacing the CRO or interrupting trial delivery.
A clinical systems analysis is a structured review of every computerized system supporting a clinical trial, across the sponsor, the CRO, and any directly contracted vendors. It produces a full systems inventory, an electronic data flow diagram, an assessment of validation status per system, and a prioritized set of actions to close the gaps found. It is how a sponsor moves from assuming its data is defensible to being able to show it.
The sponsor remains accountable regardless. Under ICH-GCP the sponsor holds responsibility for trial data integrity even where systems are managed by a vendor. When a CRO cannot supply validation records, the sponsor needs an independent assessment of which systems are in use, what their validation status is, and what compensating controls or follow-up actions are required to meet EMA and FDA expectations.
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Key Takeaways
- A Phase 2 COPD sponsor had no electronic data flow diagram and no validation documentation from its large CRO, across seven vendors in total.
- Seuss+ ran a Clinical Systems Analysis across the CRO and six directly contracted vendors, mapping every system and every data handoff in the study.
- 14 computerized systems were identified as requiring validation follow-up. 11 were managed through the CRO, 3 through direct contracts.
- A participant ID traceability risk inside the CRO's process was identified and given a fix path before it could cause cross-system data inconsistencies.
- The sponsor received 13 prioritized recommendations, a complete electronic data flow diagram, and a defined archival approach for study closeout.
A sponsor cannot demonstrate data integrity it cannot see. Before you can defend your trial data to a regulator, you need to know every system it passed through and every hand it changed. That map is not a nice-to-have. It is the foundation of oversight.
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