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For emerging biotechs · Study scoping and CRO sourcing

Get your IND-enabling studies scoped, quoted and started on time.

For emerging biotechs without an outsourcing department. I turn your program goals into studies CROs can quote the first time, find the CROs that run your model, and read the quotes line by line.

Book an intro call Get the Quote-Ready Checklist

Raising or partnering? These are the studies partners and investors diligence first. I also run partnering, research collaborations and investor readiness for biotechs.

Partnering and investors

Where delays start

Most IND timelines slip before the first animal is dosed

A loose RFP

When a CRO has to guess at group sizes, endpoints or bioanalysis, every quote comes back built on different assumptions, and none of them compare.

Long-lead items found late

Animal sourcing, study slots and bioanalytical method work can each take weeks or months to line up. They have to start before the study does.

Quotes taken at face value

Pass-through costs, markups and exclusions sit in different places in every quote. The lowest total is often the one missing something.

What I do

Four pieces of work, each with a written result

Study scoping

Your program goals turned into a design a CRO can quote the first time: species, groups, dosing, endpoints, bioanalysis and deliverables.

You getA one-page scope summary per study, ready to send.

CRO shortlist and RFP

CROs that run your study type routinely, contacted with the same request so their answers line up.

You getTwo to four comparable quotes, with CRO questions answered.

Quote review

Every quote read line by line: what's included, what's a pass-through, what's marked up and what's missing.

You getA side-by-side comparison and the questions to send back.

Sequencing

The order your IND-enabling studies need to start in, with the long-lead items called out.

You getA timeline your team and board can plan against.

Inside a CRO quote

What I check on every line

I've built quotes from the CRO side for years, so I know where the assumptions and the markups usually sit. This is the review every quote gets.

Quote reviewExample
Study conductProcedures and labor

How many dosing days, timepoints and technicians are assumed? Scope differences hide here.

Test animalsPass-through

Is a markup or sales tax applied on top of the vendor price?

HousingPer cage, per day

Do the acclimation and study days match your design?

Clinical pathologyOften subcontracted

Who runs it, which panels are included, and is it marked up?

HistopathologyPer animal or per study

Which tissues and which groups are read? Per-animal pricing scales with group size.

BioanalysisMethod and samples

Is method development or validation included, or only sample analysis?

Report and archivingDeliverables

When do draft and final reports arrive? For GLP, who archives what, and for how long?

Not listedExclusions

Shipping, test article analysis and repeat analyses are common gaps. Ask before you compare totals.

The path to IND

Where scoping help pays off

  1. Stage 1

    Lead selection

    In vitro potency, early ADME and first rodent PK.

    I help withPilot PK and tolerability designs that each answer one question.

  2. Stage 2

    Proof of concept

    Efficacy in a disease model and an early read on dose response.

    I help withModel selection and matching you to CROs that run that model routinely.

  3. Stage 3

    IND-enabling

    GLP toxicology in two species, safety pharmacology and validated bioanalysis.

    I help withPackage scoping, multi-CRO coordination and line-by-line quote review.

    Largest spend
  4. Stage 4

    IND submission

    Pre-IND meeting, final study reports and the submission itself.

    I help withReport timelines and tracking each study through to its final report.

Regulatory strategy stays with your regulatory consultant. My job is to make sure the studies behind it are scoped, quoted and scheduled.

Disclosure

I provide contract business development to Noble Life Sciences (preclinical in vivo) and Accelevir Diagnostics (bioanalytical). If either could run your study, I'll tell you at the start and still put alternatives on your shortlist. You make the choice.

Questions

Before you book a call

Are you a regulatory consultant?

No. I work alongside your regulatory advisor. They set the strategy; I make sure the studies behind it are scoped, quoted and scheduled.

Which kinds of studies do you cover?

Preclinical in vivo work (pharmacology, PK, toxicology, device studies) and the bioanalytical work that supports it, up to your IND. For clinical CRO selection, I'll tell you so and suggest where to look.

Do you also help with partnering and fundraising?

Yes. Once the data is in, I help biotechs find partners, set up research collaborations and get ready for investors. See partnering and investor support.

How is it priced?

A fixed fee per project, quoted in writing after the intro call.

What do you need from us to start?

A program summary or target product profile, any prior study data you can share, and your timeline to IND. I'll sign a CDA before you share program details.

Next step

Start with a 30-minute call.

Tell me about your pipeline or your program. If I'm not the right fit, I'll say so and point you somewhere better.

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