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Nonclinical Strategy Audit

For IND-bound programs that need clarity on what comes next - and why.

The Nonclinical Strategy Audit is a senior-level assessment of whether your nonclinical program supports the decisions you’re about to make.

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WHAT YOU GET

Within 5 business days you will receive:

  • A strategic assessment of nonclinical program

  • Identified risks & readiness gaps

  • CRO alignment considerations

  • Regulatory submission friction points

  • Study sequencing & timing map

  • Priority action roadmap

  • 60-minute readout call

MORE DETAILS

This audit is for:

  • Pre-IND and IND-bound companies

  • Programs selecting species and models now

  • Teams outsourcing all tox to CROs

  • Founders who want nonclinical leadership

  • Established startups without in-house tox

This audit provides:

  • Clear hierarchy of nonclinical risks

  • Alignment of data, interpretation, and clinical intent

  • Identification of study gaps and decision blind spots

  • An IND-aligned nonclinical narrative

Seeking fractional tox support?

The Nonclinical Strategy Audit is a great first step for teams seeking Fractional Toxicology Support. It allows for a thorough assessment of your nonclinical program to ensure alignment and fit. Fractional Toxicology Leadership is intentionally capped at three clients to maintain the depth and quality of support.

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INVESTMENT

$749, one-time

If this audit prevents even a single misplaced study, it has already paid for itself.

What Happens After You Book?

Once your audit is booked, a short onboarding sequence is triggered to ensure everything moves quickly and efficiently.

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You’ll receive:

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  • A payment receipt

  • A follow-up email outlining next steps, including:

    • A link to execute an NDA via DocuSign (or the option to provide your own)

    • Secure access to a dedicated Box folder for document upload

    • A link to schedule a 30-minute kickoff meeting

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As long as all materials are uploaded before the kickoff meeting, you can expect the full audit review document within 5 business days.

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