Building a unified statistical computing environment at scale

Q: How do you architect a unified SCE for global regulatory submissions?

You cannot treat your environment as a simple, drop-in piece of software; it must be treated as a foundation for integration. A functional SCE must explicitly connect data lakes, version control repositories, and downstream submission tracking systems. Novartis achieved this by anchoring their setup on a governed core and developing targeted system integrations via platform APIs to tie their entire data pipeline together.

Q: How can pharma organizations adapt a standard platform for clinical trial workflows?

The key is to build targeted workflow extensions that bridge the gap between native platform features and strict compliance demands. Rather than forcing researchers to adapt their daily habits to a rigid tool, Novartis built custom, automated interfaces for study provisioning, git repository management, and batch execution. This gives statistical programmers a highly structured, familiar workflow while automatically capturing complete metadata and execution logs for compliance purposes.

Q: How do you migrate legacy clinical study data to a new statistical computing environment?

Data migration cannot be treated as a casual extraction task at the end of deployment. It requires a dedicated planning workstream that runs in parallel with foundational platform development. Novartis initiated structural data mapping during their earliest phases, utilizing template-driven configurations and open lineage tracking standards to guarantee a verifiable chain of custody from the legacy source straight into the new environment.

Novartis consolidated 1,000+ statistical programmers onto a single cloud-hosted SCE on Domino, extending the platform with four purpose-built extensions to meet clinical and regulatory requirements no commercial SCE delivers out of the box.

Priya Subramaniam

Head of Dev., IT Clinical Enablement, Strategy & Growth

Novartis

Mike Harnish

President & Managing Partner

KSM Technology Partners

What you'll take away from this session

Your SCE is an integrated platform, not a standalone product

Integrations to raw data sources, regulatory submission systems, and enterprise tools are non-negotiable prerequisites rather than optional enhancements.

Automated study setup is a foundational compliance decision

Standardizing study environments through automated templates eliminates human error and variation across trials, directly reducing future audit findings and expensive remediation work.

Phased rollouts with hypercare absorbs the learning curve

Giving early adopter cohorts high-touch, hands-on support builds the collective institutional knowledge required to safely run subsequent, faster onboarding waves.

Migration planning must begin during the initial foundation phase

Mapping legacy clinical trial data early surfaces structural mismatches before they can block deployment, ensuring a clean target architecture for fully auditable study migration.

Business process redesign must accompany platform change

Installing modern software into decades-old workflows will never deliver the efficiency or quality gains the technology is capable of. The hardest legacy asset to migrate is organizational behavior.

Involve QA and compliance as architects, not reviewers

Treating validation teams as a final gate causes massive delays and unexpected rework. Collaborating on the validation strategy from day one eliminates late-stage deployment surprises.

Novartis faced a massive infrastructure hurdle: over 1,000 statistical programmers and data scientists running hundreds of active clinical studies across fragmented legacy software platforms. To streamline operations and satisfy regulatory bodies, they launched QUANTA, a project to consolidate their global statistical computing environment into a single, unified, cloud-hosted platform built on Domino.

Because no commercial tool meets every specific clinical data and regulatory submission requirement out of the box, Novartis partnered with KSM Technology Partners to extend the platform. Using Domino's APIs, they custom engineered four core extensions to handle critical workflow mechanics:

The RA Creator: A templated application that provisions data sources, code repositories, and user access in minutes instead of hours.
The Task Manager: An interface built directly into workspaces that abstracts away git command-line complexity for programmers without software engineering backgrounds.
The Batch Runner: A pipeline coordinator that reads version-controlled configuration files to execute heavy computing jobs in precise dependency order with full tracking.
The Publisher: A controlled export engine that packages final study deliverables alongside all required structural metadata for seamless delivery to downstream regulatory filing systems.

Priya Subramaniam, Head of IT Clinical Enablement, Strategy & Growth at Novartis, along with Mike Harnish, President of KSM Technology Partners, detail the execution of this multi-year transition. They share how mapping 25 years of legacy data early and prioritizing process re-engineering allowed them to shift compliance from a human behavioral check into an intrinsic property of the platform architecture itself.

FAQ

How do you architect a unified SCE for global regulatory submissions?

How can pharma organizations adapt a standard platform for clinical trial workflows?

How do you migrate legacy clinical study data to a new statistical computing environment?

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