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Bioanalytical Services
Bioanalytical services

Expert bioanalytical solutions for your drug development program

Careful oversight of bioanalytical activities in pre-clinical and clinical studies can be challenging. A4P can help your organisation by supporting the following activities:

  • Sourcing evaluation and contracting of suitable CROs across the globe.
  • Comprehensive project management and scientific oversight of method development, validation and sample analysis studies.
  • Review of bioanalytical plans, data, reports, and any additional documentation.
  • Input into clinical protocols, laboratory manuals and site communication.
  • Assistance and input into data management activities.

Our bioanalytical expertise encompasses small and large molecule therapeutics (PK, PD, Immunogenicity) and a wide range of analytical methodologies:

  • Chromatographic and Mass Spectrometry
  • Ligand Binding Assay platforms
  • Immunohistochemistry
  • Flow Cytometry
  • Genomics

Our experienced team of project managers can support all aspects of bioanalytical oversight:

  • Pre-clinical and Clinical (GLP and GCP) studies across a range of therapeutic areas and biological matrices.
  • All aspects of assay development:
    • Method development and optimisation
    • Troubleshooting
    • Data review
    • Interlaboratory assay transfers
    • Pre-clinical to clinical assay transfers
  • Assay qualification/validation in line with current regulatory guidance and best practice.
  • Review of documentation in support of sample analysis studies e.g. plans, reports and amendments/deviations.
  • Clinical study oversight related to bioanalytical activities:
    • Kit contents and laboratory manual review
    • Sampling considerations
    • Resolution of sampling issues at sites
    • Initiation of new sites
  • Data management activities:
    • Data transfer agreement authoring and review
    • Data integrity assessments
    • Data transfers from CRO to Sponsor