Expert bioanalytical solutions for your drug development program
In managing the generation of bioanalytical data for pre-clinical and clinical studies, A4P can support the following activities:
- Sourcing, evaluation, selection and contracting of CRO providers from across the globe.
- Comprehensive scientific oversight and project management of outsourced bioanalytical activities.
- Reviews of bioanalytical documents, reports and product assay summaries.
Our bioanalytical expertise encompasses;
- PK, ADA and Biomarkers for small and large molecule therapeutics utilising the following methods;
- Chromatographic and Mass spectrometry
- Ligand Binding assay platforms
- Flow Cytometry
- Pre-clinical and Clinical (GLP and GCP) studies across a range of therapeutic areas and biological matrices.
- All aspects of assay development: method sourcing, troubleshooting, redevelopment, assay transfers and translation of assays from pre-clinical to clinical.
- Assay validation and fit for purpose considerations in line with current regulatory guidance and best practice.
- Review of documentation in support of sample analysis studies.