How Proactive Data Management and Site Enablement Accelerated a Phase IIa ALS Trial
Background
Executive Summary
- Therapeutic area: Neurology – Amyotrophic Lateral Sclerosis (ALS)
- Phase: Phase IIa
- Geography: Global (Multi-site)
- Challenge: A clinical trial site approaching its interim analysis (IA) deadline experienced delays in electronic data capture (EDC) and over 100 open queries due to insufficient site engagement and operational support. Dedicated support was needed to resolve the backlog and ensure IA readiness
- Result: Database cleaned and query backlog resolved ahead of schedule, enabling early Principal Investigator (PI) sign-off and successful interim analysis.
Challenge
Stiris Research was engaged to provide clinical operations oversight and site support for a global Phase IIa ALS trial, a rare and rapidly progressing neurodegenerative disease.
ALS clinical trials require strict protocol adherence, thorough patient monitoring, and accurate data capture, making site performance and coordinator support critical for trial integrity.
As the IA deadline approached, one site with high enrollment showed limited engagement, resulting in delayed EDC entry, over 100 open queries (some >30 days old), and a growing backlog. Despite repeated escalations, this site posed a significant risk to database lock readiness and on-time IA execution.
At this critical juncture, Stiris took the lead in addressing these risks, implementing a focused approach to restore site performance, strengthen data quality, and accelerate query resolution in support of database lock readiness and on-time IA execution
Solution
- Site Management & Engagement
Stiris established a strong, trust-based relationship with the site coordinator, positioning the company as a collaborative partner focused on shared success. This approach improved communication, reduced operational friction, and increased responsiveness to both clinical and data-related needs.
- Structured Data & Query Management
A proactive workflow for data review and query management was implemented, prioritizing aging queries and EDC completeness. Weekly communications provided categorized updates—including open queries with guidance, pending data entry, and outstanding source documents—enabling faster resolution and stronger data integrity.
- On-Site Monitoring & Operational Support
During each Interim Monitoring Visit (IMV), dedicated time addressed complex data issues directly with the site coordinator. In parallel, Stiris provided hands-on administrative and regulatory support, allowing coordinators to focus on patient-facing activities while maintaining inspection-ready documentation.
Results
- IA Readiness Assessment & Planning
The Stiris clinical team conducted a full review of open queries, EDC completion, and source documents, creating a prioritized action plan aligned with the interim analysis timeline and focusing on high-risk and aging data items.
- Ongoing Monitoring & Data Reconciliation
Structured weekly communications included query triage, progress tracking, and ongoing support for EDC entry and subject tracking, preventing further backlog from patient visits.
- IMV Execution & Database Lock Preparation
Interim Monitoring Visits (IMVs) were leveraged for real-time collaboration, resolving complex data issues and reinforcing protocol adherence. All data were validated to GCP standards, audit-ready documentation maintained, and PI sign-off coordinated to support timely database lock.
Results
• Resolved 100+ open queries, including all aging queries (>30 days)
• Achieved 100% data cleaning aligned with interim analysis requirements
• Delivered query resolution 2 days ahead of schedule
• Secured early Principal Investigator (PI) sign-off
Sponsor Impact
Stiris successfully re-engaged a critical site and restored operational performance, ensuring high-quality, inspection-ready data while protecting IA timelines.
Through proactive site support and structured data management, the sponsor executed a clean, on-schedule data review—a critical milestone in rare disease programs. This approach maintained clinical development velocity, avoided database lock delays, and preserved the planned Phase IIb progression timeline, strengthening regulatory confidence and competitive positioning.
Key Takeaways
• Strong site engagement improves ALS trial data quality and timelines
• Proactive query management accelerates database readiness
• Embedded operational support stabilizes underperforming sites quickly
• On-site collaboration resolves complex data issues faster than remote escalation
• Targeted intervention recovers performance without protocol changes or delays
• Measurable impact: 100+ aging queries resolved and PI sign-off achieved ahead of IA deadline
Protect Your Critical Trial Milestones
Are you facing site performance issues, data bottlenecks, or approaching an interim analysis or database lock? Stiris Research provides clinical operations expertise and site-focused support to keep your trial on track, on schedule, and inspection-ready.
Partner with Stiris Research to re-engage sites, accelerate data readiness, and secure your next milestone in rare disease trials.