Our Solutions

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.

Clinical Study Types
 
arrow

First In Human

 

200 completed FIH studies

 
arrow

Proof of Concept

 

35 completed POC studies

 
arrow

Bioavailability/Bioequivalence

 

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

bullet45% North America

bullet45% Europe

bullet10% Other

 
arrow

PK in Special Populations

 

365,000+ participant database

 
arrow

Drud-Drug Interaction (DDI)

 

100s of DDI studies conducted

 
arrow

QT Assessment

 

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

 
arrow

Renal and Hepatic Impaired

 

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

 
arrow

Human Abuse Potential

 

bullet40+ abuse potential or substance abuse studies

bulletExperience with opioids, stimulants, cannabinoids and sedative hypnotics

 
arrow

Driving Simulation

 

10,000+ simulated drives conducted

 
arrow

Imaging

 

20+ studies requiring different imaging modalities

 
arrow

Biologics/Biosimilars

 

bullet100+ biologics studies/year

bullet28 biosimilars studies

bullet40% of recent preclinical and clinical studies conducted on large molecules

 
arrow

Cannabis

 

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

 
arrow

Smoking/Vaping

 

bullet50,000+ smokers in our database

bullet10+ studies on vaping products

 
Bioanalysis

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.

Bioanalysis

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.

Bioanalysis
LinkedIn Twitter Youtube

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 support research services and bioanalytical expertise.

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

Learn More