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
- Flow Cytometry
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
- 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