Nonclinical Efficacy Testing » Nonclinical testing: the background to settle before you commission

Nonclinical testing: the background to settle before you commission

Table of Contents

This section covers the ground a sponsor needs before writing a statement of work: which studies exist, which document governs each of them, where the good laboratory practice regulation applies and where it does not, and what the schedule and selection process actually look like. It is written for someone placing the work rather than performing it.

Articles in this section (11)

From Discovery to Approval: Where Nonclinical Work Sits in the US Process — where nonclinical work sits in the path to approval
Compound Libraries and Screening: What Is Publicly Available in the US — what screening collections are publicly available in the US
Choosing a Nonclinical CRO: Criteria, Verification, and the Steps from RFP to Contract — criteria, verification, and the steps from request for proposal to contract
How Long Drug Development Takes, and Where Nonclinical Time Is Actually Spent — how long each stage takes, and where nonclinical time is spent
Clinical Success Rates by Phase, and Why Programs Stop in Phase 2 — success rates by phase, and why programmes stop where they do
Laboratory Animals in Nonclinical Studies: Species Selection and the US Regulatory Framework — species selection, and the US framework governing animal use
GLP and GCP: Where the Boundary Falls, and What Crosses It — the boundary between the nonclinical and clinical standards, and what crosses it
What Is GLP? Good Laboratory Practice for Nonclinical Studies in the United States — what the regulation covers, and the common misreadings of it
Official Guidance for US Drug Development: Where to Find It and What It Binds — where the binding documents actually live, and what is guidance rather than law
Disease Models: What They Establish, and How to Choose One — what a disease model establishes, and how to choose one
Types of Nonclinical Study, and the Guidance Each One Follows — the study categories, and which guidance document governs each

References

21 CFR Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58 (accessed 2026-09-03)
21 CFR 312.23(a)(8) — IND content and format: pharmacology and toxicology information, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-B/section-312.23 (accessed 2026-09-03)
FDA — ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m3r2-nonclinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorization (accessed 2026-09-03)

3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise

In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.

Pharmacology (Efficacy) StudiesDisease-Relevant Models for
Translational Drug Evaluation

Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)

SMC Laboratories, Inc.

SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.

Areas of Expertise

Disease-Relevant Model Portfolio

SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.

Study Design Based on Target Biology

Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.

Support from Target Validation to Proof of Concept

With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.

Discuss your target and development objective with SMC Laboratories to identify an appropriate model and study design.

Safety StudiesComprehensive Safety Assessment for
Preclinical Development

Reference: Charles River Laboratories official website (https://www.criver.com/)

Charles River Laboratories

Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.

Areas of Expertise

General Toxicology Across Study Designs

Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.

Non-GLP and GLP Study Support

Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.

Integrated IND-Enabling Safety Assessment

Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.

Explore Charles River for integrated toxicology and IND-enabling safety assessment.

Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with
Pharmacological Response

Reference: Inotiv official website (https://www.inotiv.com/)

Inotiv

Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.

Areas of Expertise

Pharmacokinetic Characterization

PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.

Exposure–Response Evaluation

Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.

Integrated DMPK and Development Support

Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.

Explore Inotiv for integrated PK/PD, DMPK, and bioanalytical support.

Nonclinical testing: the background to settle before you commission

Articles in this section (11)

References

3 Recommended Contract Research Organizations for Non-Clinical Studies — by Target goal and Expertise

SMC Laboratories, Inc.

Charles River Laboratories

Inotiv

3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise