Appsilon's innovation platform for life sciences.

Timelines vary based on the scope of your existing SAS codebase and the complexity of your regulatory workflows. 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 to ongoing submissions. The range reflects that every organization starts from a different point in their R adoption.

Yes. The FDA has publicly stated that they accept submissions using R. Major pharma companies have already completed real-world R-based New Drug Applications to the FDA, EMA, and NMPA — not just pilots, but production submissions using open-source Pharmaverse packages. The key is proper validation — which is exactly what our frameworks like Axon.R are built to provide.

We never recommend a hard cutover. Our migrations run in parallel — your SAS environment stays fully operational while we build, validate, and QC the open-source equivalent. Teams transition gradually, often starting with new studies on the R/Python stack while existing studies complete on SAS. License costs reduce naturally as adoption shifts.

Every solution we deliver follows a validated, audit-ready process. Our Axon.R framework provides GxP-aligned R package validation with full traceability. We implement IQ/OQ/PQ protocols, maintain validation documentation, and work within your existing quality management system. Our engineers have direct experience with regulatory inspections and know what auditors look for.

Absolutely. Most of our pharma partnerships start with a scoped pilot — a single workflow automation, one study migration, or a proof-of-concept dashboard. This lets you evaluate our team, our process, and the ROI before scaling. The pilot typically delivers enough measurable value to build the internal business case for broader adoption.

We're not just consultants — we're core contributors to the tools the industry uses. Our engineers build and maintain key pharmaverse packages, contribute to the {teal}, and sit on the pharmaverse council. When you work with us, you're working with the people who shape the ecosystem, not just use it.