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A Complete Preclinical CRO Checklist: What Companies Need Before Outsourcing Toxicology & Bioanalysis

Why Preclinical CRO Partnerships Matter

For biotech and pharma innovators, preclinical studies form the critical bridge between discovery and first-in-human trials. These studies, covering safety, toxicology, pharmacokinetics, and ADA assays, provide the data needed to support an Investigational New Drug (IND) application and regulatory approval to move into the Phase I clinical trials.

Many early-stage companies and virtual biotechs rely on Contract Research Organizations (CROs) to provide the expertise, infrastructure, and regulatory know-how required to execute these complex studies. But outsourcing is not a simple transaction, selecting the right CRO and preparing properly can save significant time, cost, and regulatory risk.

This checklist highlights what companies and R&D leaders need to have in place before engaging a CRO for toxicology and bioanalysis.

Preclinical CRO Checklist

1. Define Your Program Goals Clearly

• What stage are you in, lead optimization, IND-enabling, or preparing for Phase I?
• What are your primary objectives (safety profile, dose selection, or regulatory filing)?
• Align your internal team on timelines and deliverables before discussions begin.

2. Gather Foundational Data

• Pharmacology and proof-of-concept data that support your candidate’s mechanism of action
• Initial in vitro and in vivo studies, including PK/PD data where available
• Formulation and route of administration information

This background enables CROs to design tailored study plans and avoid unnecessary repetition.

3. Clarify Regulatory Expectations

• Determine whether studies must be GLP-compliant for regulatory submission or can be exploratory.
• Familiarize yourself with FDA, EMA, or ICH guidelines for toxicology and bioanalytical studies.
• Consider pre-IND meetings to align early with regulators.

4. Prepare Your Compound Supply & Characterization

• Ensure sufficient supply of drug substance and/or formulated product for toxicology studies.
• Provide certificates of analysis and stability data.
• CROs will require details on purity, potency, and formulation to ensure study validity.

5. Establish Bioanalytical Requirements

• Select an appropriate animal model
• Define what assays you will need: PK, toxicokinetics, immunogenicity, biomarkers.
• Consider whether methods need to be validated or can remain exploratory.
• Work with CROs who can provide end-to-end method development and validation.

6. Evaluate CRO Fit Beyond Cost

• Does the CRO have expertise in your therapeutic modality (small molecule, biologic, gene therapy)?
• Can they provide integrated services (toxicology + bioanalysis + regulatory support)?
• Do they offer flexibility for startups (scalable services, adaptive timelines)?
• Assess communication, project management, and cultural fit.

7. Plan for Data Quality and Integrity

• Confirm that the CRO has strong data management systems (21 CFR Part 11 compliance).
• Request sample reports and quality assurance practices.
• High-quality, reproducible data is non-negotiable for regulatory success.

Common Pitfalls to Avoid

• Engaging too late: Waiting until just before IND filing can compress timelines and force rushed studies.
• Overlooking scalability: Choose partners who can support you beyond a single study.
• Focusing only on cost: Low bids often mean limited expertise, poor communication, or hidden delays.

How InfinixBio Helps Companies Succeed

At InfinixBio, we understand the pressures companies face: limited budgets, ambitious timelines, and high regulatory stakes. Our scientifically rigorous and operationally agile team provides:

• Integrated toxicology and bioanalysis services aligned with regulatory expectations
• Bioanalytical method development and validation to support IND submissions
• Flexible engagement models tailored for startups and virtual biotechs
• Transparent communication and project management for efficient collaboration

We help sponsors avoid costly missteps and accelerate progress toward first-in-human studies.

Are you ready to partner with a CRO you can trust?

Contact InfinixBio today to discuss how our expert team can support your toxicology and bioanalysis needs with confidence.