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Adopt a trusted R validation framework for faster regulatory submissions
Discover Axon.R – a GxP-aligned, audit-ready R package validation and maintenance framework so your teams can safely use open-source R in clinical submissions. Replace months-long package onboarding with a repeatable process that can run in hours.
Is R package validation slowing down your trials and submissions?
Book a validation strategy callOpen-source tools like R give clinical teams flexibility and access to advanced methods. But in regulated environments, package validation often becomes slow, manual, and tightly coupled to environment releases consuming time, attention, and coordination across teams.
3+ months to onboard a single package – coordinating biostats, programmers, QA, IT, and documentation.
Delays in analyses, study milestones, and ultimately regulatory submissions
No central view of which packages are approved, under what conditions, and for which use cases
Teams forced to fall back to legacy tools even when better open-source options exist
Axon.R: a pre-built, risk-based R package validation tool built for GxP
Instead of treating each R package as a one-off validation project, Appsilon helps you implement Axon.R, a standardized validation and maintenance tool and framework based on R Validation Hub best practices and extended for regulated use.
It combines risk-based assessment, controlled validation runs, containers as a validation method and audit-ready evidence.
Standardized
risk-based validation
A single, controlled process for assessing and validating public and internal R packages. Axon. R supports metric-driven scoring paired with manual risk classification informed by context-of-use.
Controlled validation runs with reproducible evidence
Validation is run in a validated execution environment, producing consistent outputs and traceable evidence for audits and internal QA.
Approval workflows
and remediation loops
Risk-level dependent approval flows and structured remediation when checks fail or evidence is incomplete so nothing is “approved by accident." Includes multi-step approvals for high-risk packages.
Repository-ready outcomes
When a package gets approved, Axon.
R can publish it to a validated repository (e.g., Posit Package Manager) and retain the key metadata and audit trail
Scalable architecture
Supports integrations with CI/CD, SSO, and other enterprise systems.
Plug into any end user environment (Posit PM, Container Images, and more).
Long-term ownership
and sustainability
You retain full ownership of the framework, code, and documentation. We train your biostats, programming, and platform teams to run and build on top, with optional support from Appsilon.
How it works
Axon.R takes packages from public or internal sources and automatically generates metrics to classify risk in the context of use. It then runs validation in a validated execution environment, produces an evidence bundle for approval, and publishes validated packages to your approved repository with full version lineage tracking.
#Timeline
From initial conversation to a fully operational framework — approximately 90 days in the best-case scenario.
Your timeline depends on the current environment (SCE/repository setup, access, integrations) and internal approval cycles (QA/Compliance). That’s why we run delivery as a milestone-based rollout with clear checkpoints.
Weeks 1–3
Assessment and Design
Mapping your current environment, risks, and package portfolio. Risk-based validation approach, draft documents, and target scope.
Weeks 3–8
Implementation Build
Configuring and setting up Axon.R in your environment. Automating key checks and validating an initial set of priority packages.
Weeks 8–12
Validation and Handover
Complete validation documentation, training your teams.Working framework in place, hand over of code and SOPs, support for audit readiness.
Beyond 3 months
Optional support from Appsilon
Ongoing help with upgrades, new packages, and framework enhancements as your needs grow.
Strategic Advantages
Full Ownership & Independence
You control the validated framework; no black-box tooling or vendor lock-in.
Regulatory Readiness
GxP-aligned tooling, templates, and documentation designed for audits and inspections.
Continuous Compliance
Structured upgrades for new R versions and security patches keep environments stable.
Empowered Teams
Training and knowledge transfer enable internal teams to run, adapt, and extend the framework.
#Valued by clients worldwide
#Configured for you. Owned by you
Evolution of Validation
Continuous Risk-Based Validation
Monolithic Validation
✅ Snapshot Agility
Teams are stuck with old versions of R and libraries, missing out on new scientific methods.
❌ System Lock-in
Teams are stuck with old versions of R and libraries, missing out on new scientific methods.
✅ Automated QA
Teams are stuck with old versions of R and libraries, missing out on new scientific methods.
❌ Validation "Theatre"
Teams are stuck with old versions of R and libraries, missing out on new scientific methods.
✅ Fully deployable - includes AWS setup, CI/CD, and SSO integration.
Teams are stuck with old versions of R and libraries, missing out on new scientific methods.
❌ Innovation Lag
Teams are stuck with old versions of R and libraries, missing out on new scientific methods.
#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
#Why Appsilon
Driven by Excellence,
Proven by Results
A trusted partner to leading pharmaceutical and life sciences organizations worldwide.
World-Class Talent
Out of 15,000+ applicants each year, only 1% are selected to join our team - a diverse group of programmers, managers, biostatisticians, and PhD-level scientists actively contributing to the industry.
Pharma Golden Standards
With over 150 projects delivered for pharmaceutical companies, you gain access to our deep, collective expertise and training support from experienced delivery managers, biostatisticians, programmers, and scientists.
Life Sciences Innovators
Our team members are creators and contributors to open-source frameworks such as Rhino, aNCA, teal, and many more—collectively downloaded nearly 500,000 times. We are active participants in Pharmaverse and R Consortium working groups.
Trusted by Global Pharma Leaders
8 out of the 10 world’s largest pharmaceutical companies have trusted our programmers and statisticians to support AI-driven workflows, analyse all types from data: from clinical and real-world data (RWD) to drug discovery experiments.
FAQs
Find clear answers to common questions about GxP compliance, helping you navigate regulations with confidence.
01.
What is R package validation in pharma and why does it matter for clinical trials and regulatory submissions?
R package validation is the process of demonstrating that the packages used in regulated workflows behave reliably and that results are reproducible and appropriately controlled. It matters because regulators require traceability, accuracy, and confidence in the statistical results produced.
02.
How can pharma and biotech safely use open-source R and Python in a regulated environment?
Yes — the FDA’s Statistical Software Clarifying Statement confirms that any software, including R, is acceptable for submissions as long as it is documented, reproducible, and appropriately controlled.
03.
How long does it take to implement an R package validation framework in an existing environment?
Our teams can implement Axon.R in 8–12 weeks, depending on existing quality processes, governance maturity, automation readiness and integration needs.
04.
How long does it take to validate a package with Axon.R?
Axon.R is designed to turn validation into a repeatable workflow that can be completed in hours or days (depending on package risk level, evidence requirements and human processes), rather than being blocked by multi-month release cycles. Typically within the industry, we see system releases and outdated processes being a particular bottleneck for packages to be released. With Axon.R you can have packages released in under a week.
05.
What’s the biggest bottleneck preventing faster package approval today?
Most teams are slowed down by manual workflows (documentation, reviews, approvals, and re-validation triggered by environment changes) coupled with outdated or fragmented processes and tooling that slow down documentation, dependency checks, and reproducibility verification.
06.
Is package validation just a standalone activity or part of a broader system?
Package validation is only one layer; full compliance usually requires governed infrastructure, controlled environments, auditability, and lifecycle management. This is typically accomplished through a broader Statistical Compute Environment (SCE).
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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.