“I would like to thank you all for your continuous support and contributions. We are looking forward to continuing working with you and hopefully making a difference.”Sr. Clinical Trial Manager
Mid-size Biotech Company
Integrated Pharmacokinetic Services
The safety and efficacy of a drug are eminently influenced by absorption, distribution, metabolization and excretion of it. To enable effective implementation of a drug through clinical development, Pharmacokinetic (PK) and Pharmacodynamic (PD) Assays are well-recognized and powerful tools to better understand the Mode of Action (MoA) and to find the efficacious dose regimen.
Barc Lab has entered into a strategic alliance partnership with Frontage Lab for PK and Biomarker analysis, a true leader in the field. Together, we can offer experience in the development and implementation of PK, Toxicity, bioanalytical and biomarker analyses. Frontage Lab, a CLIA Certified Laboratory, operates both in US and China under strict adherence to ICH and US FDA guidelines. Please, see their website www.frontagelab.com for futher information.
The growing potential of Biomarkers in clinical trials
Next to monitoring the efficacy of a drug by PK & PD, biomarkers are used to predict response to treatments and to anticipate the prognosis of individual patients. Especially in the new era of personalized medicine, well-defined biomarkers are a critical asset. It is imperative to find the Right biomarker for the Right target in the Right Tissue for the Right Patient treated with the Right treatment.
Barc Lab can provide either targeted approaches or broad immune profiling and multifactorial biomarker approaches to identify one or a variety of biomarkers, depending on the stage of your clinical trial and the purpose of the biomarker:
- Steer dose selection
- Characterize Mode of Action
- Patient stratification
- Predict drug response
- Prognosis of patients
- Monitor disease
Our offer at a glance
- MSD S600 Meso Scale Discoveries
- Bioplex 200 Luminex
- ELISA platform
- Magpix Luminex
- Quanterix Simoa HD1
- Ella Protein Simple System
- Life Technologies Realtime PCR platforms
- Illumina sequencers for genomewide analysis
- Immunohistochemistry platforms for tissue biomarkers
Next to customization of commercial kits, our scientific team can assist and advice on the development of new biomarkers. We strive for a quality driven approach by analytically validated assays and ensuring that our labs are GLP and/or CLIA certified.
As there is no ‘one size fits all’, we are dedicated to work with you to find the best possible solution that meets your requirements:
- Transfer of the assay established at your premises
- Assess method feasibility
- Development and validation of the assay customized to your needs
- Analysis of samples
At Barc Lab, we acknowledge that biomarkers are fast evolving and playing a more important role in clinical studies of today and of the future. With markers off-the-shelf and the ability to offer customization of new commercial markers, we can offer you with enough expertise and experience to help and run your clinical trial as smooth as possible.