GLP Preclinical Sample Analysis

At Biotrial, our GLP-certified contract laboratory uses mass spectrometry, and we have over 20 years of technical application and experience in all phases of regulated drug development. We specialize in accurately measuring parent drug and/or metabolite concentrations in various biological matrices.

 

Biotrial-Bioanalysis-Clinical-Sample-Analysis

Bioanalytical Services

Biotrial supports pharma and biotech companies in their drug development programs by performing high-throughput analysis of samples obtained from preclinical studies through late-phase clinical studies for innovator compounds..

  • Early stage clinical samples
    PoC: Proof of Concept
  • Early stage clinical samples
    SAD: Single Ascending Dose
  • Early stage clinical samples
    MAD: Multiple Ascending Dose
  • DDI: Drug-drug interactions
  • Food effect
  • Pharmacokinetics / Toxicokinetics studies
  • Bioavailability studies
  • Bioequivalence studies

Timeline

  • 12 Subjects  –> QCed Data 5 working days (approx. 350-400 samples)               
  • 24 Subjects  –> QCed Data 5-10 working days (approx. 700-800 samples)
  • 36 Subjects  –> QCed Data 10-15 working days (approx. 1000-1200 samples)
Biotrial Bioanalysis Clinical preclinical Sample Analysis

Study Support Platform

Watson™ V7.4.2 LIMS (Laboratory Information Management System) software enables efficient and high-quality bioanalytical testing.

Watson LIMS follows study from initiation to study closeout, while enabling compliance with regulations; GLP, 21 CFR Part 11 as well as FDA Bioanalytical Method Validation and EMA guidance. 

Biotrial Bioanalysis Glp Compliant
  • Common human matrices: Blood, plasma, serum, urine, feces
  • Explicit human matrices : Cerebrospinal Fluid (CSF), pleural effusion, aqueous humour
  • Animal matrices from: mouse, rabbit, rat, dog, non-human primate, minipig, etc.

Animal tissue

  • Heart tissue
  • Kidney tissue
  • Liver tissue
  • Lung tissue
  • Skin tissue
  • Spleen tissue
  • Brain tissue

Participate in a clinical trial

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