Altasciences

Altasciences is a mid-size early phase contract research organization in Canada and the U.S., working as a single CRO/CDMO partner from lead candidate selection to proof of concept. Its services include preclinical safety testing, clinical pharmacology from first-in-human to end of Phase II, bioanalysis from preclinical to Phase IV, research support services, and manufacturing and analytical services.

Preclinical Development and IND Enabling

• Advance candidate selection with GLP repeat-dose toxicity testing, specialized immunotoxicology, safety pharmacology, pathology, and in vivo pharmacology studies. Altasciences also conducts pharmacokinetic and pharmacodynamic studies in animal models, including ADME assessments and PK modeling.
• Plan IND-enabling programs through custom nonclinical studies covering toxicology, safety pharmacology, and supporting laboratory work under global regulatory requirements. Its Acceleration Platform is an integrated framework that compresses nonclinical-to-clinical timelines by running steps in parallel.

Clinical Pharmacology, Bioanalysis and Biomarker

• Run first-in-human and early-phase clinical pharmacology studies in healthy volunteers and patient populations, with support for clinical study design, bioavailability and bioequivalence testing, and clinical PK/PD analysis.
• Generate bioanalytical data for small- and large-molecule programs using LC-MS/MS and ligand-binding assays. Clinical laboratories quantify drugs, metabolites, biomarkers, and immunogenicity for nonclinical and clinical studies, while translational teams develop customized biomarker assays and high-resolution mass-spectrometry analyses.

Manufacturing and Clinical Study Delivery

• Develop formulations and manufacture drug products under GMP, including tablets, capsules, injectable products, liquid and powder-filled capsules, and clinical trial materials. Services also include primary and secondary packaging, blinding of study materials, ICH stability storage and testing, analytical method development, and product testing.
• Execute clinical studies through project management, study start-up, site contracting, clinical monitoring, medical monitoring, participant recruitment and retention, and clinical sample logistics. Supporting services include clinical data management, biostatistics, SDTM programming, medical writing, regulatory operations, and IND assembly, submission, and maintenance. Its Tell Us Once™ approach shares each sponsor's preferences and study information across teams and phases, so clients don't have to repeat themselves.

Best Fit

• Best suited to biotechnology and pharmaceutical teams seeking a CRO/CDMO partner for preclinical safety and IND-enabling work, first-in-human and early-phase clinical pharmacology, bioanalysis, clinical operations, or related drug-product manufacturing.