Veramed provided independent unblinded statistical support for multiple DMC deliveries for a large pharma client’s Phase 2b double-blind, dose-ranging study and long-term extension. Through two proactive dry runs, granular internal time management and flexible resource planning, multiple outputs were delivered within timelines approximately 50% shorter than standard expectations. 

The challenge

Veramed was engaged to support a Phase 2b randomized, double-blind, dose-ranging study, followed by a long-term extension study. The scope included: 

• Independent unblinding of provided blinded datasets 
• Independent production of unblinded tables, figures, and listings (TFLs) for multiple DMC reviews via client-provided executable code 
• Monthly safety outputs aligned with pre-defined stopping rules 
• Interim and primary analysis deliverables for the extension study 

The key challenge was the exceptionally tight 5-day turnaround required for the primary analysis, alongside a complex delivery that included: 

• A high volume of outputs: 77 tables/listings 
• Multiple safety and efficacy endpoints, including Modified Mayo Score, patient-reported, Simple Endoscopic Score and Crohn’s Disease Activity Index 
• Adapting sponsor-provided code as needed to ensure runs correctly on unblinded data, requiring careful validation and review 
• Incorporation of several additional outputs 

The solution

To address these challenges, maintaining high quality standards while delivering on tight timelines, Veramed deployed a thorough approach: 

Two dry runs 

• Dry Run 1: Identified critical issues in code and outputs; enabled detailed sponsor feedback 
• Dry Run 2: Executed under real timelines to confirm readiness 

Structured Delivery Management 

• Granular timelines (morning/afternoon tracking) to identify risks early 
• Shared issues log to improve visibility across blinded and unblinded teams 
• Thorough independent statistician review of all outputs 

Flexible Resourcing 

• Contingency planning and ring-fenced resource to be able to mobilize quickly following database lock and ensure delivery timelines were met 
• This planning and flexibility enabled the incorporation of last-minute additional outputs

“Awesome! Thanks to you and your team for on-time delivery including additional 7 outputs.”

Client Lead

The outcome

The proactive and structured approach delivered clear results: 

• Following database lock 2 days ahead of schedule, primary analysis was delivered within the remaining 7 days to meet the very tight deadline 
• Additional exploratory analyses were delivered 9 calendar days earlier than agreed 
• All outputs were produced smoothly and efficiently, with no last-minute issues 
• Recipients received high-quality, reliable outputs to support decision-making 
• Regular monthly safety reporting and DMC deliverables were additionally consistently delivered to standard 

Importantly, the sponsor recognised Veramed’s commitment to quality and delivery excellence, helping to support critical activities beyond the sponsor’s internal capacity. 

Key learnings from this work have been applied more broadly across Veramed, in particular the use of two dry runs and granular internal timelines to support delivery under high pressure and fast turnaround. 

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