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Clinical pharmacology trials in drug development

Altasciences - Pharmacokinetic trials in drug development

For your clinical pharmacology trials, our experts leverage more than 25 years of experience in designing, conducting, analyzing, and reporting on studies required for labeling. Our expertise covers all clinical pharmacology studies required for regulatory submissions across a wide range of therapeutic areas to support small molecules and biologic drug development, as well as reformulations (hybrid or 505(b)(2) submissions) for biopharmaceutical companies of every size, worldwide.


First In Human


200 completed FIH studies


Proof of Concept


35 completed POC studies




1,600 completed BA/BE studies for drug submissions in:


PK in Special Populations


365,000+ participant database


Drud-Drug Interaction (DDI)


100s of DDI studies conducted


QT Assessment


40+ studies and multi-year, multi-million dollar contracts by NIH/NIDA and FDA


Renal and Hepatic Impaired


Single site option for renal studies and network of sites with large hepatic impaired databases


Human Abuse Potential


40+ abuse potential or substance abuse studies

Experience with opioids, stimulants, cannabinoids and sedative hypnotics


Driving Simulation


10,000+ simulated drives conducted




20+ studies requiring different imaging modalities




100+ biologics studies/year

28 biosimilars studies

40% of recent preclinical and clinical studies conducted on large molecules




~40 studies on cannabis products, cannabinoids, or requiring previous or current cannabis use




50,000+ smokers in our database

10+ studies on vaping products


Our bioanalytical scientists work in our state-of-the-art laboratories located in the U.S. and Canada with both LC-MS/MS and ligand binding capabilities to provide support for all stages of drug development, from preclinical studies (non-GLP and GLP) through all phases of clinical development (Phase I-IV) for both small and large molecules.

In addition, our Scientific and Regulatory Affairs teams are always abreast of the latest guidances and produce high quality designs, focusing on maximizing efficiency, and reducing risk to ensure your clinical trial milestones are met on time.

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Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.

Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.

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Working as a flexible, attentive extension of your team, we offer all you need to move your molecule forward.