Through experienced DMC support, Veramed helped a sponsor navigate a highly complex Phase IIb study in non-alcoholic steatohepatitis (NASH), delivering interim analyses while simultaneously acting as a central coordination hub for unblinded data access. With carefully planned governance and stakeholder coordination, Veramed ensured the integrity of the study while enabling confident decision-making within a complex multi-stakeholder environment.
The challenge
The study was a Phase IIb trial in non-alcoholic steatohepatitis (NASH), involving multiple interim analyses designed to support adaptive decision-making, including the potential introduction of additional dose levels or genotype-driven cohorts.
The core challenge was governance-driven, arising from the need to manage complex and highly controlled data access across multiple stakeholder groups.
- Maintaining study integrity and blinding: A blinded sponsor team was responsible for day-to-day study operations, while a small group of unblinded individuals within the sponsor supported interim decision-making. In addition, specialist functions such as PK and metabolism required targeted insights, requiring tightly controlled, role-specific access to data to avoid unintentional unblinding.
- Complex data flows across committees and functions: Distinct outputs were required for different audiences, including blinded sponsor team, unblinded IDMC members for safety review, and an independent data review committee (IDRC) within the sponsor for adaptive efficacy assessments. In addition, external vendors provided potentially unblinding data reports.
- Internal coordination challenges within the sponsor organization: It was challenging for the sponsor to share unblinded data and information internally in a controlled way, creating reliance on a structured coordination to manage access and minimize the risk of inappropriate data sharing.
The solution
Veramed took ownership of these challenges by leading the operational governance of data access and coordination. Rather than focusing only on the statistical analysis requirements, we collaboratively defined and proactively implemented a structured framework utilizing ShareFile. We maintained a central control point for unblinded data, ensuring that access remained tightly governed while enabling efficient collaboration.
Key elements included:
- Controlled access to unblinded data
Ensuring that only authorized individuals received information aligned to their role, preserving blinding across all stakeholder groups. - Coordinated stakeholder communication and data flow
Managing the distribution of outputs across committees and functions, while aligning consistent messaging across statistical, clinical and PK teams.
“I would like to acknowledge the excellent support provided by [the Veramed] team throughout the iDMCs and IA activities, as well as their flexibility”
Client Lead
The outcome
The study progressed successfully through its interim decision point with full integrity and confidence in the results. Despite the complexity of the stakeholder environment, all data sharing remained tightly controlled, ensuring appropriate access and preservation of blinding.
The analyses enabled informed decision-making without requiring modifications to the study design, allowing the trial to continue as planned and progress into a long-term extension phase.
Critically, Veramed’s role extended beyond statistical analysis to:
- Acting as a trusted partner managing sensitive data access.
- Ensuring regulatory and scientific integrity with robust audit trail.
- Enabling efficient collaboration across internal sponsor teams.
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