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Brilliant science deserves operational infrastructure

Bowlyn builds AI-powered playbooks and tools that help emerging biotech teams go from protocol to first patient enrolled — without reinventing the wheel.

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Global
Clinical operations
experience
E2E
Trial management
IND to approval
Proven
Programs successfully
taken to market
The Problem
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.
Two products built for the reality of running trials at emerging biotechs. Powered by AI. Validated by experience.
Flagship

FPIQ™

Your complete study startup infrastructure — built in hours, not weeks. Upload your protocol or synopsis and receive customized SOPs, site selection frameworks, vendor oversight tools, and communication templates tailored to your trial. Optional protocol development support includes CtQ design review, feasibility assessment, and ICH E6(R3) compliance alignment. Powered by Bowlyn Navigator. FPIQ™: First Patient In — Qualified, Quickly, with Quality.

Starting at $1,500  ·  Powered by Bowlyn Navigator
VP on Demand

Bowlyn Bridge

Your dedicated VP of Clinical Operations — accessible through a private client portal and by email, with answers within 24 hours. Onboard your program once; ask anything from CRO governance to site activation timelines. Every response is reviewed by a real clinical ops expert before it reaches you. Not a chatbot. A real person, every time.

Monthly retainer — contact us for pricing
Your VP of Clinical Ops. On demand. Always in the loop.
Bowlyn Bridge is a dedicated portal for your clinical ops questions. Onboard your program once — protocol, phase, countries, CRO model — and your team gets a private client portal plus a dedicated email address. Submit questions through the app or by email. We respond within 24 hours with expert, program-specific answers. Not a chatbot. A real clinical ops expert reviewing every response before it reaches you.
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Arion Therapeutics  ·  Bowlyn Bridge
We're evaluating two CROs for our Phase 2 — what should our governance charter actually cover for a 20-site US/EU trial?
Great timing to nail this before selection. For a trial at that scale, your governance charter needs three tiers: weekly Joint Project Team (JPT) calls at the working level, monthly Joint Steering Committee (JSC) for strategic decisions, and quarterly executive reviews. Build in a formal escalation pathway with defined Service Level Agreements (SLAs) — and KPIs that distinguish activity from outcomes. Want me to draft the full framework with meeting cadence, roles, and KPI language?
Ask your VP 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

All AI runs through enterprise API infrastructure where your data is contractually never used for model training. Encrypted at rest and in transit, with tenant isolation between customers. 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.

Clinical ops consultants who want to work smarter

You serve multiple clients, each with their own protocol and complexity. Bowlyn gives you expert infrastructure on demand — so you deliver faster and with more depth.

Clinical development leaders without dedicated ops support

You're driving the science and the strategy — but the operational infrastructure isn't keeping pace. You need a partner who can translate your development plan into trial-ready execution.

“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

Our team brings global clinical operations experience, end-to-end trial management expertise, and a track record of successful approvals — across therapeutic areas and development phases, at emerging biotechs, CROs, and large pharma.

FAQ
Common questions.
How is this different from ChatGPT?
ChatGPT gives generic answers. The clinical ops methodology behind Bowlyn is built from deep, real-world trial execution — not scraped from the internet. When you ask us to build a CRO oversight plan, you get 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 and phases. The operational frameworks we use — study startup, CRO management, regulatory submissions, risk management — are indication-agnostic. We work across a range of indications and adapt to the complexity of your specific program.
Do I need to commit to a long-term contract?
No. Starter kits are one-time purchases. Bowlyn Bridge is a monthly retainer you can cancel anytime. We earn your business every month.
Your first patient shouldn't have to wait.
Stop reinventing the wheel. Get the clinical ops infrastructure your trial needs — from day one.
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