ACL Digital Life Sciences Transformed Real-World Evidence Challenges Into Scalable Solutions in Complex NIS Trials
Overview
Non-interventional studies (NIS) play a crucial role in generating real-world evidence and evaluating the safety, tolerability, and effectiveness of marketed drugs in routine clinical settings. These studies reflect actual medical practices and comply with approved marketing authorizations, providing vital insights beyond the confines of controlled clinical trials.
Despite their value, NIS trials are often hindered by the absence of standardized guidelines, especially in statistical programming. This ambiguity can result in increased resource effort, inefficiencies, and instead of misaligned outcomes—challenges that ACL Digital Life Sciences is uniquely equipped to overcome.
ACL Digital Life Sciences applied its deep domain expertise, agile methodologies, and specialized programming capabilities to support two pivotal NIS successfully: one focused on glaucoma progression and another on geographic atrophy in Age-related Macular Degeneration (AMD).
Download Case Study
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
Unanticipated Statistical Requirements
In some studies, initial statistical plans lacked comprehensive details, leading to urgent requests for data summary outputs (Tables, Listings, and Figures—TLFs) under extremely tight timelines
Frequent Changes to Analysis Plans
Sponsors required significant flexibility to revise the Statistical Analysis Plan (SAP) even after project commencement, adding complexity to the execution
Limited Resources and Budgets
NIS projects typically operate with leaner budgets and more constrained timelines compared to interventional studies, requiring high efficiency without compromising quality
Data Complexity and Protocol Deviations
Real-world studies often involve non-standardized medical practices, increasing the likelihood of protocol deviations and other data integrity challenges that can delay or derail project progress
Solution
- Efficient Programming & Rapid Turnarounds: Leveraging streamlined processes and targeted lead programmer training, ACL Digital delivered high-quality TLF outputs within stringent timeframes.
- Proactive Change Management: By anticipating SAP adjustments and utilizing its extensive experience in NIS analytics, the team adapted swiftly and ensured continuous project momentum.
- Cost-Conscious Execution: ACL Digital Life Sciences delivered results within limited budgets by prioritizing automation, reuse of standardized code modules, and focused resource allocation.
- Advanced Issue Resolution: Expertise in managing protocol deviations and complex trial designs enabled the team to mitigate potential data inconsistencies early and ensure clean, actionable datasets.
Outcomes
- Accelerated Data Delivery: Timely completion of TLFs ensured the sponsor could meet regulatory and internal deadlines without compromise
- Greater Analytical Flexibility: ACL Digital’s ability to adapt to changing SAPs helped maintain scientific rigor while accommodating evolving sponsor needs
- Cost Efficiency Without Quality Sacrifice: By aligning resources and tools to project constraints, ACL Digital delivered value without exceeding budgets
- Risk Mitigation in Real-World Settings: Skilled handling of non-standardized data, protocol deviations, and observational challenges minimized project risk and enhanced data integrity
