Expert non-clinical statistical services for drug development

Delivering high-quality statistical support for non-clinical programmes, ensuring a strong scientific foundation for clinical development.

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How our expertise supports every stage
of non-clinical development

Bringing together non-clinical statistics and specialist expertise to strengthen preclinical evidence, guide key development decisions and support a smoother path into clinical trials.

Study design & experimental strategy

Robust preclinical designs that minimise experimental bias and support data-driven decisions.

Design & analysis consulting Advice on appropriate statistical designs and analysis methods across in vivo and in vitro work.
Dose-response & Justification of Dose Dose-response designs and JoD selection for first-in-human trials.

Methods & techniques

Design of Experiments (DoE)
Dose-response modelling
Sample-size calculations & simulation

Toxicology, PK/PD & bioassay statistics

The statistical evaluation behind safety, exposure and potency across the preclinical programme.

Toxicology statistics Single/repeat-dose, reproductive tox, genotoxicity and carcinogenicity — NOAEL / STD10.
PK/PD analysis Compartmental, non-compartmental and population PK with dose-response modelling.
Biomarker & immunogenicity Biomarker analysis and anti-drug-antibody (ADA) cut-point determination.

Methods & techniques

NOAEL / STD10
Population PK
ADA cut-points
Bioassay parallelism & calibration
In vivo / in vitro evaluation

CMC, data standards & compliance

Manufacturing statistics and submission-ready data that stand up to FDA and EMA review.

CMC & stability statistics CMC statistical input, stability and shelf-life, batch comparability and content uniformity.
Data standards (SEND) Preclinical data in SEND format — controlled-terminology mapping, validation, eCTD-ready.
Regulatory authority support Full FDA / EMA compliance and support for regulatory-authority interaction.

Methods & techniques

Stability & shelf-life
Batch comparability
SEND format
Data visualisation
FDA / EMA compliance

First-in-human bridging & regulatory writing

Carrying preclinical evidence into the first-in-human protocol and the submission that supports it.

First-in-human bridging Bridging preclinical results into FIH protocol input — SAD/MAD design and exposure-response.
IND / CTA tox sections Module 4 and 2.4 preclinical sections for FDA / EMA / Swissmedic submissions.
Custom dossier reports Summary tables, graphs and presentations organised and transformed into eCTD format.

Methods & techniques

SAD / MAD design
IND / CTA Module 4
IB preclinical chapters
eCTD packaging

From preclinical evidence to first-in-human

We connect non-clinical analysis and reporting so the evidence behind your first-in-human programme stays clear, consistent and defensible, from toxicology studies through to IND submission.

Metronomia non-clinical team reviewing study data together

Decisions trace back to the data

Dose selection, safety margins and biomarker thresholds are built on the preclinical data behind them, giving first-in-human decisions a clear statistical rationale.

Analysis and writing, one roof

We analyse toxicology, PK/PD and CMC data and carry that evidence into the documents that follow, including toxicology reports, IND/CTA Module 4 and Investigator’s Brochure content.

One continuous evidence chain

We keep the non-clinical analysis connected to the clinical work that follows, so the FIH protocol, SAP and IB build on the same evidence and assumptions.

Non-clinical + clinical, together

Our non-clinical and clinical statisticians work together, bringing specialist methods such as DoE and bioassay analysis into the wider clinical development programme.

Connected non-clinical expertise

Statistical analysis and regulatory writing work together to keep the evidence consistent, traceable and ready to support the next stage of development.

Non-Clinical Statistical Services

Study design & analysis planning
Toxicology & safety statistics
PK/PD data analysis
Dose-response modelling
Bioequivalence support
Regulatory statistical reporting

Non-Clinical Medical Writing

Non-clinical study reports
Investigator brochures
Regulatory documentation
Safety summaries
Module-ready writing support
Submission documentation

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