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