ACL Digital Life Sciences Rescued A Complex LDK378 Oncology Trial With Zero Compromise on Quality
Overview
A promising new treatment for ALK-positive non-small-cell lung cancer (NSCLC)—LDK378 (ceritinib)— required swift, large-scale clinical evaluation to reach patients in need. Preclinical studies show that LDK378 has excellent antitumor activity, and it offers an alternative treatment option for patients who haven’t responded to other therapies. ACL Digital Life Sciences stepped in to rescue a critical trial suffering from delays, incomplete deliverables, and operational inconsistencies. By providing deep domain expertise, structured quality processes, and rapid analytics, ACL Digital accelerated the path to FDA approval and ensured data integrity at every stage.
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Challenges
The project’s scope was ambitious and technically demanding. These complexities necessitated a solution that combined scalable infrastructure, robust statistical expertise, and dynamic team collaboration
The trial had to be rescued from a previous vendor due to chronic issues: missed timelines, inconsistent communication, and incomplete deliveries
The study was characterized by high complexity, featuring multiple endpoints, extensive data refreshes, and tight reporting deadlines
Frequent deliverables, such as DMC reviews, interim analyses (IAs), clinical study reports (CSRs), periodic safety updates, and medical affairs outputs, required real-time coordination
Needed to maintain 100% accuracy and data integrity while generating and refreshing high volumes of data
Lack of clear failure criteria previously led to delays in escalation and corrective action
Solution
ACL Digital Life Sciences implemented a multi-pronged rescue strategy focused on quality, speed, and scientific rigor:
- Expert Deployment: Senior and principal leads with clinical rescue experience were assigned to regain control and drive consistency across workstreams.
- Quality Framework: A structured QA approach was used to measure deliverable accuracy, compliance, and consistency.
- Escalation Protocols: Clear failure criteria and escalation mechanisms enabled faster recovery when challenges arose.
- Advanced Analytics
- Applied statistical techniques like randomization and power analysis for optimized trial design
- Conducted subgroup analysis to refine understanding of patient profiles (e.g., ALK mutation status, prior therapies).
- Assessed efficacy and safety with statistical significance, ensuring regulatory-grade outputs.
- Automation at Scale
- Generated 600 reports weekly, accommodating ad-hoc requirements through automation.
- Developed custom macro utilities to streamline recurring tasks and ensure compliance across reports.
- Collaboration & Continuity: Retained key talent and ensured seamless handoffs across functions—from data management to programming, biostatistics, and medical writing.
Outcomes
- Trial Back on Track: ACL Digital Life Sciences restored timeline discipline and quality, rescuing a mission-critical study from derailment
- Operational Scale: Delivered 600+ reports weekly, meeting tight timelines without sacrificing precision
- Scientific Impact: Supported robust conclusions through advanced statistical methods and high-integrity data management
- Regulatory Success: LDK378 (ceritinib) received FDA approval, validated through ClinicalTrials.gov (NCT01828099), confirming its superior potency over crizotinib in preclinical studies
- Sustainable Model: The flexible resourcing and automation framework allowed the sponsor to focus on strategic development while minimizing operational overhead
