Clinical Analytics Solutions

Clinical Analytics Solutions by Notilyze is a service and platform offering aimed at growing biotech organisations that need to transition from flexible early-stage research environments to controlled, regulatory-grade statistical analytics environments. The offering is designed to support teams moving into clinical phases where reproducibility, traceability, and compliance become requirements for regulatory submission.

Notilyze positions the solution around the idea that early research tools built for flexibility are insufficient for clinical submission, and that a governed analytics backbone must be established alongside innovation tooling. The offering includes a readiness assessment, consulting, and a path toward a validated statistical compute environment.

Core Requirements for Clinical-Phase Analytics

• Full traceability of data transformations
• Reproducible and auditable analytical workflows
• Structural Clinical Data Repository (CDR)
• Controlled and validated compute environment

Capabilities Supporting Faster Time to Market

• Parallel processing for faster analytical outputs
• Accelerated Tables, Listings, and Figures (TLF) generation
• Reduced rework and validation cycles
• Scalable environment designed to grow with expanding trials

Clinical Analytics Readiness Assessment

Notilyze offers a structured assessment to help biotech organisations evaluate whether their current data and statistical analytics environment is prepared for regulatory scale. The assessment covers the following areas:

• Current tool landscape review
• Regulatory exposure analysis
• Data architecture maturity evaluation
• CDR and Statistical Computing Environment (SCE) roadmap planning
• Practical next steps for remediation or advancement

Notilyze is a SAS partner based in Rotterdam, Netherlands, and the assessment is led by Michael Gomes, Resell Director and Member of the SAS Partner Advisory Board, who brings over 20 years of experience in data management, clinical research, and analytics within the life sciences industry. The offering references SAS Viya as part of the validated compute environment pathway.