Automation, Standardization & Migration to Open Source

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We optimize analytics data workflows, help adopt data standards, automate regulatory deliverables, and migrate you to validated open-source solutions or help you adopt a multilanguage setup while automating the most time-intensive parts of your process.

Results That Compound Across Your Organization

From operational speed to strategic positioning, our automation and migration work delivers impact at every level of your organization.

Operational Acceleration

We eliminate repetitive manual work. Submission dossier creation for ICH eCTD modules, including Clinical Summary and Study Reports built on SDTM/ADaM datasets, becomes streamlined.

Strategic Advantages

Open-source solutions deliver significant cost reduction while eliminating vendor lock-in. Standardizing now lays the foundation for AI-driven analytics tomorrow.

Talent Advantage

Modern open-source tooling attracts the next generation of data scientists. Your existing team stays engaged because the expertise is transferable and career-building.

How We Helped Our Partners

Cut Submission Dataset Exports from 12 Hours to 20 Minutes

A global pharmaceutical company reduced a 40GB submission dataset export from an overnight run to about 20 minutes, making delivery timelines more predictable for submission teams.

Full-Spectrum Capabilities

From R/Python ecosystem work to AI-driven TLF generation, we cover the entire analytics modernization lifecycle.

Timeline
R & Python Workflows

Package development, testing, documentation, open-releasing and validation across your analytics ecosystem.

Engineering
Productionizing & Scaling

Best engineering practices applied to existing fragmented workflows and analytics infrastructure.

Standards
ARD/ARS Implementation

Working with CDISC datasets, generating metadata, and implementing analysis results standards.

AI
Automated TLF Generation

Leverage AI for automated Tables, Listings, and Figures generation from standardized data.

Delivery
Regulatory Submissions

End-to-end support for submission dossier creation aligned with ICH eCTD requirements.

#Why Appsilon

Not just a vendor.
A force multiplier.

We bring ecosystem access, regulatory experience, and elite talent that compounds your capabilities.

Pharmaverse Council Members

We sit on the pharmaverse council, develop core packages, and contribute to the ecosystem. You gain access to our deep connections and collaborative innovation.

Proven with Regulators

Partnered with Eli Lilly and R Consortium on pilot FDA submissions. We know what regulators expect and how to deliver it with open-source tooling.

Real Pharma Experience

We've helped 8 of the top 10 pharma companies modernize their analytics workflows. We understand the regulatory constraints, organizational dynamics, and technical debt you're working with.

Core Open Source Contributors

Appsilon engineers serve as core contributors to the {teal} framework, sponsored by Roche. Our team shapes the tools your teams rely on.

How We Work With You

From operational speed to strategic positioning, our automation and migration work delivers impact at every level of your organization.

Weeks 1–3

Discovery & Audit

Audit your SAS codebase, map regulatory workflows, identify automation opportunities, and define the pilot scope — typically one study's TLF pipeline.

Weeks 3–8

Standards & Foundation

Set up validated R/Python environment, implement CDISC data standards, establish Git workflows, and validate priority packages with Axon.R.

Weeks 8–16

Automate & Migrate

Automate TLF generation, migrate the pilot workflows to open source, run QC in parallel with SAS, and deliver the first R-based outputs.

Month 4+

Scale Across the Organization

Expand to additional studies and teams. New studies launch on R/Python, SAS licenses phase out naturally. AI-driven analytics become possible.

#Valued by clients worldwide
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#Our Clients About Appsilon

How It Feels to Work with Us

We rely on Appsilon's expertise to support the build and maintenance of critical clinical reporting software based in R and Shiny.

Data Engineering Lead

Top 10 Pharma Company

Appsilon team is exceptional. The engineers challenge and speak their minds, which helps do justice to the product.

Associate Director

Top 50 Pharma Company

We wouldn't be here where we are now without Appsilon. I want this partnership to keep going and growing.

Human Resources People Partner

Top 10 Pharma Company

Expert Insights

Insights, Inspiration & Distilled Knowledge

Read More
Ebook for Clinical Data & Platform Leaders

Your Guide to Building a Better SCE

Learn how pharma companies are building validated, flexible platforms to support both regulatory submissions and modern analytics.

FAQs

Find clear answers to common questions about GxP compliance, helping you navigate regulations with confidence.

A focused pilot — migrating a single study's TLF pipeline — typically takes 8-12 weeks. Full-scale enterprise migrations are phased over 6-18 months, running parallel to existing SAS workflows to ensure zero disruption.

Yes. The FDA accepts submissions using R. Major pharma companies have completed real-world R-based NDAs to the FDA, EMA, and NMPA using Pharmaverse packages. Proper validation is key — which is what Axon.R provides.

We never recommend a hard cutover. Migrations run in parallel — SAS stays fully operational while we build and validate the open-source equivalent. Teams transition gradually, often starting new studies on R/Python.

We're core contributors to the tools the industry uses. Our engineers build key pharmaverse packages, contribute to {teal}, and sit on the pharmaverse council. You work with the people who shape the ecosystem.

Contact Us

Drive Impact with Appsilon

From custom dashboards and applications to AI-powered solutions and compliant computing environments, our engineers and infrastructure architects accelerate clinical development within fully validated, regulatory-compliant frameworks.