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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

 

Bioavailability/Bioequivalence

 

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

 

Imaging

 

20+ studies requiring different imaging modalities

 

Biologics/Biosimilars

 

100+ biologics studies/year

28 biosimilars studies

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

 

Cannabis

 

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

 

Smoking/Vaping

 

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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THERAPEUTIC AREAS

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.