AI systems for life sciences,
designed and delivered.
The problem isn't whether AI works.
It's whether it works inside your reality.
Life sciences AI doesn't fail because the technology doesn't work. It fails because nobody designed for the regulatory reality, the workflow reality, or the integration reality.
The assessment that became a deck.
The familiar pattern: six-figure assessments that produce paperwork, not working systems.
- AThe pilot that never went to production.
- BThe vendor demo that didn't survive contact with your compliance team.
- CThe strategy deliverable that became a slide deck on a shared drive.
A working system in production.
We don't sell strategy as a standalone deliverable. The strategy work exists to make sure we build the right system.
- AA working system, built on the design agreed in Phase 1.
- BCompliance-mapped escalation paths and safety triggers.
- CLive training, post-launch refinement, and a clean handover to your team.
A boutique studio.
Founder-led. Built by experienced hands.
APV operates as a build studio, not a consultancy. Engagements are led directly by Nic Valle, with specialized contractors brought in for delivery scale when scope requires it.
Experienced hands end-to-end
From structuring how insights are organized, to designing AI behavior, to mapping every decision against compliance — the founder stays involved end-to-end. The person who scopes your engagement is the person who builds it.
Speed without sacrificing rigor
Boutique footprint means decisions move at the speed of conversation, not the speed of a steering committee. No partners pitching, no juniors building, no hand-offs between sales and delivery.
Compliance-first by design
Every design decision is filtered through 21 CFR Part 11, GxP, GDPR, and HIPAA — not retrofitted at the end. We've delivered software to this standard for a decade.
Practical AI systems
for life sciences teams.
APV builds AI systems for the operational functions of small-to-mid biotech and specialty pharma — Medical Affairs, Clinical Operations, and Commercial Operations. Every engagement is scoped end-to-end: strategy, build, training, and post-launch refinement.
Engagements typically focus on:
Medical Affairs intelligence
Turn MSL field insights into clear, timely strategic intelligence — weekly briefs, disease-state summaries, and dashboards your Medical Director and team can act on.
Clinical Operations AI
Turn site monitoring and operational trial data into early signals — data quality flags, site performance trends, and reporting your study team can act on before issues compound.
Commercial intelligence
Platforms that consolidate fragmented data sources into decision-ready dashboards.
Built by someone
who has delivered this before.
APV is led by Nic Valle, a clinical software executive with 10+ years building validated, production-grade platforms for life sciences — serving rare disease biotech and Top 10 Global Pharma sponsors. Most recently, Managing Director of a $5M+ clinical technology division.
- i.10+ years building validated, production-grade clinical software platforms — leading 25+ cross-functional staff and serving Top 10 Pharma sponsors at Red Nucleus.
- ii.30+ global clinical studies overseen across North America, EMEA, LATAM, and Australia.
- iii.30,000+ patient videos captured and analyzed for clinical endpoints on a platform built and led from founding through Phase 3 validation.
- iv.Pharma-grade compliance under 21 CFR Part 11, GxP, ALCOA+, GDPR, and HIPAA.
- v.Active practitioner in clinical AI — built and deployed facial recognition for trial video de-identification, led ML and multimodal LLM strategy for automated clinical assessment.
Let's scope your engagement.
A 30-minute scoping call is the right place to start. We'll discuss your operational pain, the AI opportunity, and whether an APV engagement is the right fit. No deck required. We respond within two business days. All inquiries are reviewed personally by Nic Valle.
Workflow Implementations run 10–14 weeks across three milestone-aligned phases. Custom Platform Builds run 4–9 months, scoped per engagement. Strategic Discovery engagements are fixed-scope, 3–4 weeks.