ABOUT · QUALITY COMMITMENT

Quality is what makes biomarker data trustworthy.

Every result Altheome delivers carries real consequences – for drug development programmes, for clinical trial endpoints, for patients whose treatment depends on the science.

We operate the quality framework that work demands: HTA licensed (licence 12818), compliant to GCP and adherent to GLP and ISO 15189, supported by documented procedures, trained scientists, and a sample chain of custody that holds from arrival to archive.

Every result Altheome delivers carries real consequences – for drug development programmes, for clinical trial endpoints, for patients whose treatment depends on the science.

Request our quality documentation

Our quality philosophy

Quality, for us, is not a department.

It is how every project at Altheome is run, from the first scoping conversation through to the final dataset delivered. We design that way because our clients’ work – biopharma programmes advancing toward clinical trials, academic studies feeding into publications, biotech research shaping the next generation of therapies – needs data they can build on without going back to check it.

That commitment shows up in three places: in the formal accreditations and standards we operate to, in the documented quality systems that govern every sample and every assay, and in the senior scientists who stay accountable from study design through delivery.
None of those alone is enough; together, they’re what we mean when we say our data is trustworthy.

Accreditations and standards

Altheome’s laboratory operations are anchored on four formal frameworks. Each plays a different role; together they cover the full quality landscape biomarker work demands.

Human Tissue Authority certified · Licence 12818

HTA

The HTA is the UK regulator overseeing the storage and use of human tissue under the Human Tissue Act 2004. Our HTA licence (licence number 12818, verifiable on the HTA website) confirms that we meet the regulatory standards for consent, traceability, governance, and storage that handling human samples in the UK requires – and that an external regulatory body has independently verified those standards.

Compliant to Good Clinical Practice

GCP

GCP (ICH E6) is the international quality standard for clinical trials. Operating in compliance with GCP means the work we deliver meets the standards regulators expect for clinical-trial bioanalysis – data integrity, traceability, audit-readiness, and the scientific rigour that clinical endpoints require. Suited to biomarker work intended for inclusion in clinical trial datasets, regulatory submissions, and biopharma development programmes.

Adherent to Good Laboratory Practice

GLP

GLP (OECD principles, adopted by the MHRA in the UK and FDA in the US) is the international quality standard for non-clinical safety and toxicology studies. Our laboratory operations adhere to the principles of GLP, supporting preclinical bioanalytical work that needs the data integrity, traceability, and rigour required for safety endpoints. Formal GLP accreditation is on our active accreditation roadmap.

Adherent to ISO 15189

ISO 15189

ISO 15189 is the international standard specifically for medical laboratories, covering both quality management and technical competence. Our quality systems, documentation, and technical procedures adhere to the standard. Formal UKAS accreditation to ISO 15189 is on our active accreditation roadmap.

How quality runs through every project

Accreditations describe a framework. What matters in practice is what happens when a sample arrives at our laboratory. Every project at Altheome runs through the same controlled workflow:

Documented standard operating procedures

Full sample chain of custody

Equipment qualification and routine quality control

Trained scientists, regularly assessed

Internal audit, deviation, and CAPA management

Document and data control

Documented standard operating procedures

Full sample chain of custody

Equipment qualification and routine quality control

Trained scientists, regularly assessed

Internal audit, deviation, and CAPA management

Document and data control

Data integrity and confidentiality

Biomarker data is only as valuable as it is trustworthy – and only as useful as it is protected. Our data integrity practices follow the principles regulators expect for clinical-trial bioanalysis: every result is attributable to the person who generated it, recorded at the time it was generated, kept in its original form, and preserved alongside the audit trail showing how it was produced.

In practice, that means audit trails on every instrument and analysis system, controlled access to electronic records, version-managed analysis procedures, and retention schedules that preserve raw data alongside processed results. Client data and samples are handled under strict confidentiality – your study, your data, your IP.

Regulatory frameworks we work to

Beyond our formal accreditations, our work is informed by current regulatory guidance from the major international authorities. Depending on the study type and intended use of the data, we work in accordance with:

ICH E6 (R2/R3) – Good Clinical Practice
ICH M10 – Bioanalytical Method Validation and Study Sample Analysis
FDA Guidance for Industry – Bioanalytical Method Validation for Biomarkers (fit-for-purpose, context-of-use framework)
EMA Guideline on Bioanalytical Method Validation
Relevant MHRA guidance for UK-based laboratory work

Specific regulatory frameworks for individual projects are agreed during study design – we work with your QA team to align our procedures to the standard your programme requires.

Quality documentation and audit support

Biopharma sponsors and clinical trial QA teams often need to see the underlying quality documentation before committing samples to a laboratory. We have what you need:

Quality policy and quality manual
Standard operating procedures (relevant to your study)
Equipment qualification and calibration records
Training and competency records
HTA, GCP, GLP, and ISO 15189 documentation

Oligonucleotide-conjugated antibodies capture the target, release it, and capture it again. Each step strips away unbound antibody and non-specific complexes, so the background that limits conventional immunoassays is removed before the signal is ever read.

These are made available on request, under appropriate confidentiality terms. We are also open to sponsor audit – we welcome QA review as part of vendor qualification, and routinely make our quality documentation, SOPs, and equipment records available for inspection.

Beads are loaded into an array of femtolitre-scale wells, each sized to hold a single bead, and sealed.

If you’re scoping a study and need to assess our quality framework before committing, we’d rather have that conversation early than late.

Request our quality documentation

Quality leadership

Quality lives or dies on whether it’s owned at the top of the organisation. At Altheome, overall responsibility for laboratory operations, regulatory compliance, and quality systems sits with Robert Crayton, our Chief Operating Officer.

Robert’s background spans physiology, biomedical science, and global operations across regulated medical and scientific environments – the kind of breadth that makes quality something the leadership team owns rather than delegates. He works closely with the scientific team to ensure that the rigour you see in our accreditations shows up in every project we run.

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Continuous improvement

Our quality framework is a foundation, not a finish line. Accreditations and quality milestones currently on our active roadmap include:

Formal GLP accreditation – extending our current adherence to GLP with formal external certification
UKAS accreditation to ISO 15189 – extending our current adherence into formal UK accreditation
Additional ISO standards – accreditation against further relevant standards is in active progress
Participation in external quality assessment (EQA) schemes – ongoing benchmarking against reference laboratories, supporting independent verification of analytical performance

We will publish updates on these as they are achieved.

Quality you can verify – not just take our word for.

If your project needs a UK biomarker laboratory you can trust with clinical-trial-grade samples – or if you’d like to assess our quality framework before scoping a study – we’d welcome the conversation.

Request our quality documentation

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