Services / CRO qualification & study oversight

09 / Pillar

CRO qualification, study audit and oversight.

Independent CRO qualification, scientific protocol review, in-life monitoring, and study report audit — built so the studies commissioned generate data that holds under regulatory review and integrates cleanly into the dossier.

Laboratory rat — in vivo toxicology study

Frameworks: OECD GLP · OECD TGs
ICH GCP · ICH M10
Modalities: In vivo · In vitro
Bioanalytical · Clinical
Lifecycle: Strategy · Qualification
Oversight · Reporting
Outputs: Vendor audit · Protocol review
RSS · CAPA plan

What we do

Scientific oversight from CRO selection to dossier integration.

Most studies that fail to deliver fit-for-purpose data fail before the bench — at the point where study type, dose levels, dosing route, formulation strategy, and endpoint coverage are decided. These decisions sit upstream of the CRO and require scientific judgement aligned with the regulatory question. We work across protocol design, in-life conduct, and report review to ensure those decisions are made with the regulatory question, the substance, and the dossier in view — by regulatory toxicologists with direct experience of evaluating-authority scrutiny.

Reviewer question 01

In vitro study fitness for purpose

Does the assay measure the endpoint the regulatory question requires, is the test system biologically relevant to the human (or environmental) target, and are findings interpretable at realistic exposure conditions?

Reviewer question 02

In vivo study conduct

Are dose levels selected to achieve systemic exposure across the range, is the MTD justified without confounding artefacts, and are decision points during conduct supported by documented scientific reasoning?

Reviewer question 03

Analytical sufficiency

For ecotoxicity, were test concentrations verified analytically and substance stability confirmed? For metabolism and TK, was the analytical method validated for the matrix and exposure markers verified at relevant time points?

Reviewer question 04

Report integrity

Is the final report structured around the regulatory question and consistent across raw data, statistical analysis, pathology findings, and interpretation?

Laboratory animal welfare — study oversight

Lowest defensible animal use — with data the regulator accepts the first time.

OECD GLP · OECD TGs · ICH GCP · ICH M10 · GLP inspectorate guidance

Scope of support

Where we step in.

Across the study lifecycle, from CRO selection through to dossier integration.

Pre-commissioning strategy

Before a study is commissioned, evaluation of whether the regulatory data gap can be addressed through read-across, (Q)SAR, weight-of-evidence, or waiving — and where in vivo testing remains necessary, definition of the study scope, type, and design that addresses the regulatory question with the lowest justifiable animal use. Strategy aligned with the specific regulatory framework (REACH, BPR, ICH) and the dossier the data will support.

OECD TGs · ECHA R.7 · EFSA · ICH S-series · 3R

CRO qualification & vendor assessment

Independent qualification and periodic requalification of CROs and key vendors. Assessments cover scientific capability for the study type, GLP standing and inspection history, facility capacity for the substance class (including challenging materials such as corrosives, UVCBs, or unstable formulations), SOP framework, training records, and data integrity controls. Targeted vendor audits delivered where required, with structured recommendations supporting informed outsourcing decisions.

OECD GLP · OECD Compliance Monitoring

Protocol design & review

Strategic input on study design before commissioning, covering dose selection principles (including MTD reasoning for repeated-dose studies), dosing route justification for the substance class, endpoint coverage against the OECD guideline, satellite or cohort design where relevant, and — for in vitro studies — selection of test systems biologically relevant to the regulatory question and the intended target.

OECD TGs · ECHA R.7 · ICH S-series

In vitro & in vivo study oversight

GLP-focused oversight of non-clinical studies covering facility systems, study conduct, raw data traceability, and report consistency. For in vivo: decision-point support during dose range-finding, interim discussions on MTD confirmation, and review of clinical signs, body weight, pathology, and reproductive endpoints for coherence with the dose-response and protocol rationale. For in vitro: review of test system performance, control acceptability, and assay readout consistency.

OECD GLP · OECD TGs

Analytical & bioanalytical oversight

Scientific oversight of analytical work supporting the study — verification of test concentrations and substance stability in the test medium for ecotoxicity studies, and review of analytical method validation, matrix suitability, and systemic exposure markers for metabolism and toxicokinetic studies. Bioanalytical method validation reviewed against ICH M10 expectations.

ICH M10 · OECD GLP · OECD GD 23

Clinical (GCP) study audit and oversight

Independent GCP audit and oversight of clinical studies, including site conduct, documentation systems, and trial master files. BA/BE oversight covering sample handling, method validation, and pharmacokinetic reporting — supporting data reliability and inspection readiness.

ICH E6(R3) GCP · ICH M10

Draft report review & dossier integration

Independent scientific review of draft study reports against raw data, statistical analysis, pathology findings, and protocol commitments. Identification of inconsistencies or interpretive gaps before submission, preparation of robust study summaries for IUCLID upload (REACH, BPR), and integration of study findings into the broader dossier WoE.

ECHA R.4 / R.7 · IUCLID RSS

CAPA, inspection readiness & response support

Translating audit findings into corrective and preventive action plans, preparing for regulatory inspections, and responding to authority questions where studies are challenged during dossier evaluation. Responses tied directly to the study record and the regulatory question.

CAPA · Inspection readiness

When clients engage us

What prompts the call.

A study team reviewing a protocol — The first conversation Most engagements begin with *one study to commission, audit, or defend* — and a regulatory deadline that pre-dates the study timeline.

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Registrants facing an ECHA compliance check requiring new in vivo testing under a defined deadline. Sponsors weighing CRO proposals against protocol adequacy and substance-specific risk before commissioning. Active substance dossiers requiring higher-tier studies at renewal under BPR. Clients reviewing commissioned study reports before submission, where independent scientific review is needed before the dossier is locked.

Case study

OECD 422 commissioning under ECHA compliance check.

Anonymised engagement

Following an ECHA compliance check decision, a REACH registrant was required to generate Annex VIII data for a corrosive substance within a defined testing deadline. An OECD 422 combined repeated-dose and reproductive/developmental screening study was mandated. The substance's intrinsic corrosivity created dosing-route challenges, and EU-based laboratory capacity within the required timeline was limited.

Challenge

A study with a fixed regulatory deadline, two operational constraints, and one scientific risk — limited EU CRO capacity within the testing window; intrinsic corrosivity of the test substance, with the risk that local irritation at the dosing site would confound systemic toxicity interpretation; and non-compliance exposure with the CCH decision if testing was not initiated promptly.

Approach

01
Reviewed the CCH decision and clarified the specific regulatory expectations, with assessment of the substance's physicochemical and hazard profile and explicit evaluation of corrosivity implications for dosing route selection.
02
Provided strategic study design input, including justification for dietary administration to minimise local corrosive artefacts and enable interpretable systemic toxicity data, and defined dose selection principles aligned with OECD TG 422 and REACH expectations.
03
Qualified a suitable GLP-compliant Indian CRO, including evaluation of GLP standing, inspection history, OECD 422 experience, facility capability to handle corrosive test materials, SOP framework, and formulation analytical capacity. Targeted audit and technical discussions confirmed operational readiness before placement.
04
Reviewed and refined the study protocol prior to initiation, including dose-level justification and MTD determination criteria. Participated in interim discussions during dose range-finding to evaluate tolerability, systemic exposure markers, and local effects, ensuring the selected high dose met MTD expectations without confounding interpretation.
05
Monitored critical study phases for protocol adherence, OECD 422 compliance, and GLP integrity. Reviewed draft reports for consistency between raw data, toxicological interpretation, and final conclusions before integration into the IUCLID dossier.

Outcome. OECD 422 study commissioned, qualified, and delivered within the CCH deadline, with a dosing strategy that mitigated confounding corrosive artefacts. The resulting dataset was GLP-compliant, internally consistent, and integrated into the updated IUCLID dossier as Annex VIII repeated-dose and reproductive screening data.

Questions we hear

Five questions, answered straight.

Five questions that come up early in most study engagements. If yours doesn't fit, send it through anyway — we'd rather hear the question than guess at it.

Can you help us avoid testing through a NAM justification first?

Always our first question. We screen for read-across, (Q)SAR and existing data alternatives before recommending new testing — only commissioning studies where the data gap is genuinely unfillable otherwise.

How do you select a CRO?

On three criteria: current GLP standing for the specific TG, adequacy of historical control data for the strain and endpoint, and demonstrated capacity to deliver the timeline. Cost is a fourth criterion — not the first.

Can you author or review protocols before commissioning?

Yes. We author or audit protocols against the specific TG, the regulatory question driving the study, and the dossier the data will land in — surfacing gaps before they become deviations.

Do you provide in-life monitoring?

Yes. Deviation review, decision-point support at trigger weeks, QA-audit shadow and statistical pre-review — ensuring the report is buildable from the in-life data.

Can you defend a study report under regulatory questioning?

Yes. We review the question against the report, identify the data or reasoning under challenge, and draft the structured response — reinforcing GLP standing, reliability and biological interpretation as needed.

Start the conversation

Tell us the study, the substance, the deadline.

Tell us the study type, the substance, and the regulatory clock. We'll come back with an initial scope and a fit assessment.

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