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Adopt a Trusted R Validation Framework for Faster Submissions
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Discover Axon.R — a GxP-aligned, audit-ready R package validation and maintenance framework. Replace months-long package onboarding with a repeatable process that runs in hours.
What Axon.R Delivers
Replace months-long package onboarding with a repeatable, risk-based process that runs in hours. Axon.R standardizes validation for GxP environments.
Standardized Risk-Based Validation
A single, controlled process for assessing and validating public and internal R packages with metric-driven scoring and context-of-use classification.
Reproducible Validation Evidence
Validation runs in a controlled execution environment, producing consistent outputs and traceable evidence for audits and internal QA.
Repository-Ready Outcomes
When a package is approved, Axon.R publishes it to a validated repository and retains the key metadata and full audit trail.
How We Helped Our Partners
Building a GxP Environment for Workflow Optimization
Appsilon’s solution leverages Infrastructure as Code and supports effective collaboration, standardizes processes, ensures regulatory compliance, and strengthens risk mitigation for this major pharmaceutical client.
How It Works
From assessment through handover, Axon.R covers the full validation lifecycle.
Assessment
Standardized Risk-Based Validation
Metric-driven scoring paired with manual risk classification informed by context-of-use for public and internal R packages.
Approval
Approval Workflows & Remediation
Risk-level dependent approval flows and structured remediation when checks fail. Includes multi-step approvals for high-risk packages.
Validation
Controlled Validation Runs
Validation runs in a controlled execution environment, producing consistent outputs and traceable evidence for audits and internal QA.
Architecture
Scalable Architecture
Supports integrations with CI/CD, SSO, and enterprise systems. Plugs into Posit Package Manager, container images, and more.
Repository
Repository-Ready Outcomes
Approved packages are published to a validated repository with full version lineage tracking, metadata retention, and audit trail.
#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.
From Conversation to Operational Framework in ~90 Days
Replace months-long package onboarding with a repeatable, risk-based process that runs in hours. Axon.R standardizes validation for GxP environments.
Weeks 1–3
Assessment & Design
Mapping your current environment, risks, and package portfolio. Risk-based validation approach, draft documents, and target scope.
Weeks 3–8
Implementation Build
Configuring Axon.R in your environment. Automating key checks and validating an initial set of priority packages.
Weeks 8–12
Validation & Handover
Complete validation documentation, team training. Working framework in place, handover of code and SOPs, support for audit readiness.
Beyond 3 months
Optional Ongoing Support
Help with upgrades, new packages, and framework enhancements as your needs grow.
#Valued by clients worldwide
#Contact Form
Consult with Our Experts for Custom Solutions
Get in touch
with Appsilon Experts
with Appsilon Experts
We will contact you within 24 hours!
#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
What is GxP Validation in Clinical Software Development?
Make FDA submissions and GxP validation easier with tips and best practices tailored for clinical software development.
Paweł Przytuła
Read more
Ebook for Directors in Clinical Trials
Get Your Copy Today
Explore how open-source technology, particularly R and Shiny, is transforming clinical trials and the broader pharmaceutical industry.
FAQs
Find clear answers to common questions about GxP compliance, helping you navigate regulations with confidence.
01.
What is R package validation and why does it matter for regulatory submissions?
It's the process of demonstrating that R packages used in regulated workflows behave reliably and produce reproducible results. Regulators require traceability, accuracy, and confidence in statistical outputs.
02.
How long does it take to validate a package with Axon.R?
Validation becomes a repeatable workflow completed in hours or days depending on risk level, rather than being blocked by multi-month release cycles. Packages can be released in under a week.
03.
How long does implementation take?
Approximately 90 days from initial conversation to a fully operational framework, depending on your environment setup and internal approval cycles.
04.
Do we own the framework after handover?
Yes. You retain full ownership of the framework, code, and documentation. Appsilon provides optional ongoing support for upgrades and new packages.
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.