FMP plays a pivotal role in drug development’s discovery phase, leveraging advanced expertise and cutting-edge technologies to craft customized bioanalytical strategies for discovery programs.
Leveraging a holistic multi-omic approach, we delve deep into biomarker/target discovery and validation, laying the foundation for robust disease understanding.
Our expertise extends to elucidating the intricate mechanisms of action underlying various diseases, empowering pharmaceutical and biotechnology companies throughout this critical phase.
In pre-clinical research, we offer comprehensive services from early to late stages.
Our expertise includes biomarker studies, drug safety and efficacy assessments, drug concentration quantification, and custom assay development, providing tailored solutions for advancing biomedical science.
Leveraging both in vitro and in vivo experiments, we rigorously evaluate the effects of drugs to ensure thorough understanding and informed decision-making throughout the drug development process.
In clinical development, our support spans phases 1 to 3, encompassing a wide array of services. We investigate short-term adverse reactions, evaluate drug activity, measure efficacy, and discover prognostic and diagnostic biomarkers. We also initiate CDx development, evaluate drug effects and adverse events, and validate drug response signatures and biomarkers clinically. Furthermore, we conduct CDx CoU validation and develop custom assays, ensuring comprehensive assistance throughout the clinical trial journey.
In the post-approval phase, we remain steadfast in our commitment to ensuring the ongoing safety and efficacy of approved treatments.
Our comprehensive post-market surveillance program includes diligent monitoring of long-term biomarker efficacy, safety profiles, and the balance of risks and benefits associated with the use of pharmaceutical products. Leveraging advanced technologies and methodologies, we conduct thorough assessments to identify any emerging concerns and promptly address them to safeguard patient well-being. Additionally, we undertake the production of CDx kits, facilitating the integration of personalized medicine approaches into clinical practice and enhancing patient care outcomes.
Samples Collection – Kick off design – Scientific support
Quality control – Labelling – Barcoding – Blinding
LIMS Registry > Freezing (-4 to -150°C) > Monitoring (24/7)
Samples Aliquoting – Extraction Services – Custom Protocols
Genomics – Epigenomics – Transcriptomics – Proteomics – Metabolomics
Bioinformatics & ML – Statistics – Internal Data Storage
Raw Data – Custom Analysis – Data Visualization