Bowlyn builds AI-powered playbooks and tools that help emerging biotech teams go from protocol to first patient enrolled — without reinventing the wheel.
Enterprise tools weren’t built for you. So you build from scratch. Every. Single. Time.
Emerging biotechs face the same regulatory complexity as Pfizer — with a fraction of the resources and no operational playbook.
Reinventing the wheel
Every new study means rebuilding SOPs, trackers, and workflows from scratch. Your team spends more time on process than on the trial itself.
Drowning in ambiguity
No infrastructure to guide decisions. Endless pivots, tight budgets, and a team of three doing the work of thirty with no institutional knowledge to fall back on.
Enterprise tools, startup budget
Veeva costs $200K+. IQVIA is built for big pharma. The tools that exist weren’t designed for you — and nobody is building for you either.
How It Works
From protocol to operational infrastructure in three steps.
No consultants. No six-month implementations. No enterprise sales cycle.
1
Share whatever you have
Protocol not final? No sweat. Start with a concept, synopsis, or full draft. Share whatever you know — phase, indication, countries, outsourced model. The more context, the more tailored the output.
2
Get tailored infrastructure
Receive customized SOPs, study startup plans, vendor oversight frameworks, risk registers, and operational playbooks — in hours, not weeks.
3
Launch your trial faster
Hit the ground running with operational infrastructure that would normally take months to build. Your team executes instead of reinventing.
Product Lines
Everything your clinical ops team needs — under one roof.
Three product layers built for the reality of running trials at emerging biotechs. Powered by AI. Validated by experience.
Flagship
FPIQ™
First Patient In — Qualified, Quickly, with Quality. AI-powered study startup playbooks, SOP libraries, site selection frameworks, vendor oversight tools, and communication templates. Includes optional protocol development support — CtQ design review, operational feasibility assessment, complexity/burden checks, and ICH E6(R3) compliance alignment. Upload your protocol or synopsis and get operational infrastructure tailored to your trial — in hours, not weeks.
Starting at $1,500
Intelligence
Bowlyn Copilot
An AI assistant trained on clinical operations best practices and your own operational data. Ask it anything — from building a CRO oversight plan to drafting a site activation timeline. Like having a seasoned VP of Ops on call 24/7.
Starting at $200/mo
Coming Soon
The Platform
Intelligent clinical ops software with AI-powered agents that monitor your trial milestones and flag risks before they become delays. Automated risk detection, smart workflows, and predictive insights.
Contact us for early access pricing
Bowlyn Copilot
AI that knows clinical ops — not just language.
Generic AI produces generic outputs. Bowlyn Copilot is built on decades of real-world clinical operations experience, available exclusively to Bowlyn subscribers. Request a demo to see how it delivers answers a generalist model never could.
Help me build a CRO oversight plan for our Phase 2 oncology trial — 20 sites, US and EU, full-service CRO.
Here’s a tailored CRO governance framework for your trial. Given your size and scope, I’d recommend a three-tier structure: weekly JPT meetings at the working level, monthly JSC for strategic decisions, and quarterly executive reviews. Let me build out the full plan with KPIs, escalation pathways, and meeting cadence...
Ask Bowlyn Copilot anything...
Built Different
Your protocol never touches a public AI model.
We built privacy into the architecture, not as an afterthought. Because your legal team was right to ban ChatGPT for protocol work.
Protocol-Tailored Outputs
Upload your protocol, get customized SOPs, checklists, and timelines — not boilerplate templates from a generic AI.
Enterprise-Grade Privacy
API-only AI access, SOC 2-compliant infrastructure, data encrypted at rest and in transit. Your protocol data stays yours.
Cross-Company Intelligence
Learns from patterns across dozens of biotech teams — what works, what fails, and the common mistakes at each stage.
Who This Is For
Built for the teams that enterprise forgot.
If any of these sound familiar, Bowlyn was built for you.
Emerging biotechs (15–50 employees)
Running Phase 1–3 trials with lean teams, tight budgets, and no inherited infrastructure or institutional playbook.
Clinical ops leaders building from scratch
You’re the first (or only) ops hire. Every SOP, tracker, and workflow has to be created before the trial can move forward.
Teams managing full-service CROs
You outsourced the trial but not the accountability. You need governance frameworks, KPIs, and oversight plans — yesterday.
Boards and investors pushing for speed
The timeline was set before ops was consulted. Now you need infrastructure that compresses months of setup into weeks.
“Trials don’t fail because the science was wrong. They fail when protocols can’t be executed, vendors work in silos, and operational plans are reactive instead of proactive.”
— The founding principle behind Bowlyn
Built by clinical operations leaders with 35+ years of combined experience across oncology, rare disease, and quality assurance at emerging biotechs, CROs, large pharma, and medical device companies.
FAQ
Common questions.
How is this different from ChatGPT?
ChatGPT gives generic answers. Bowlyn Copilot is trained on proprietary clinical operations methodology built from 35+ years of real-world trial execution. When you ask it to build a CRO oversight plan, it produces something you can hand to your VP of Clinical Development — not a Wikipedia summary.
Is my protocol data safe?
Yes. All AI runs through enterprise API tiers where input data is contractually never used for model training. Your protocol never touches a public AI model. Data is encrypted at rest and in transit, and each customer’s data is logically isolated.
Who is this built for?
Clinical operations teams at emerging biotech companies with 15–50 employees running Phase 1–3 trials. If you’re building operational infrastructure from scratch with a lean team and a tight timeline, this is for you.
What therapeutic areas do you cover?
Our methodology applies across therapeutic areas. Our deepest experience is in oncology and rare disease, but the operational frameworks — study startup, CRO management, regulatory submissions, risk management — are indication-agnostic.
Do I need to commit to a long-term contract?
No. Starter kits are one-time purchases. The Copilot is a monthly subscription you can cancel anytime. We earn your business every month.
We’re building this for Clinical Operations leaders who are starting fresh — but aren’t starting from zero.
They want to build with speed, structure, and leverage from day one. Join the waitlist and be the first to access Bowlyn’s playbooks and AI-powered tools.