Lab21 Services

 

Lab21 is a specialist diagnostic company offering fully accredited clinical trial support services and a full range of product and Companion Diagnostics development, manufacture and commercialisation capabilities.

Companion Diagnostics

An increasing number of drugs in development require or benefit from a Companion Diagnostic to:
  • Stratify patients based on predicted efficacy or toxicity
  • Monitor drug efficacy
  • Monitor drug levels
The need for such biomarker assays may be recognised before, during or after clinical trials, and their use can significantly aid regulatory approval and re-imbursement. Any diagnostic test intended for use in clinical practice should also be fully validated and regulatory approved for adoption. It is therefore important to develop such assays as early as possible in the drug development process.  Ideally, fully validated companion diagnostics will be used during the clinical trials, and these diagnostics should be commercialised at the time of drug launch in all relevant geographical markets, otherwise drug market entry may be delayed.

Lab21 is a vertically integrated diagnostic company capable of developing Companion Diagnostics and other biomarkers:
  • From concept to validated assay used in clinical trial testing
  • From clinical trials to regulatory approval and manufacturing
  • For commercialisation as products through our global distribution network
  • For commercialisation as services through our clinical laboratories in the UK and the US
Lab21 clinical trial, development, manufacturing and clinical laboratories are fully accredited to meet the requirements of the global marketplace.

For more information, please see the Companion Diagnostics Overview page.

Clinical Trials

We have wide experience in providing esoteric and routine diagnostic services for clinical trials including patient stratification, drug efficacy, genotyping and biomarker analysis.

Lab21 clients include leading companies in the CRO, Pharmaceutical and Biotechnology industries and we have successfully completed multiple projects and clinical trials using molecular diagnostic, pharmacogenetics, pharmacokinetics, drug resistance, immunoassay and routine marker analysis.

Our expert services use gold standard commercial assays or bespoke assays developed by Lab21 from initial biomarker identification or by transfer of Client’s technology or IP.

Lab21 clinical trials services include full project management, data management (21CFR Part 11 compliant) and logistics services to our Clients on an individual basis. We can manage the clinical sites with world-class logistics, sample tracking and ability to rapidly, securely and efficiently move samples globally.

Lab21 is focused on providing accredited, cost-effective services with rapid, clinically relevant test turnaround times. We are a flexible, Client-oriented organisation and aim to build a strong and smooth working relationship for the duration of the project and beyond. Our services also include Project Management, Data Management, Sample Logistics and Sample Storage.

For more information, please see the Clinical Trials Overview page.