Calvert Labs
Altasciences is a forward-thinking, mid-size contract research organization offering biopharmaceutical companies a proven, flexible approach to early drug development, including preclinical safety testing, clinical pharmacology (Phase I to Phase II), bioanalysis (preclinical to Phase IV), research services, manufacturing, and analytical services. They operate in Canada and the U.S., providing integrated solutions to support faster and more complete early drug development decisions, from lead candidate selection to proof of concept and beyond. They also provide specialized early phase clinical trial units across Los Angeles, Kansas City, and Montréal, with extensive capabilities and expertise to support various therapeutic areas and long-term studies.
Industries
Nr. of Employees
medium (51-250)
Calvert Labs
Cary, North Carolina, United States, North America
Services
GLP and non‑GLP in vivo safety studies, pivotal toxicology, safety pharmacology and PK/PD studies across multiple species to generate regulatory‑enabling safety data.
Design and conduct of first‑in‑human, SAD/MAD, proof‑of‑concept, BA/BE, DDI, special population and functional assessment studies in Phase I/II settings, with on‑site clinical units, regulated pharmacies, cardiac safety units and specialized functional testing (driving simulation, imaging).
Method development, transfer, validation and sample analysis for small and large molecules using LC‑MS/MS, ligand‑binding, PCR and other specialized assays; high monthly throughput and assay repository support.
Formulation development, scale‑up from prototype to commercial manufacturing, clinical supply and packaging, with environmental monitoring and controlled‑substance handling.
Preparation of SEND‑compliant datasets, define files and Study Data Reviewer’s Guide; interim and final dataset delivery, validation and QC, and conversion of third‑party data into SEND format.
CRF/eCRF design aligned to CDASH, database build and validation, data cleaning, medical coding, SAE reconciliation and formatted data transfers per sponsor specifications.
GLP and non‑GLP in vivo safety studies, pivotal toxicology, safety pharmacology and PK/PD studies across multiple species to generate regulatory‑enabling safety data.
Design and conduct of first‑in‑human, SAD/MAD, proof‑of‑concept, BA/BE, DDI, special population and functional assessment studies in Phase I/II settings, with on‑site clinical units, regulated pharmacies, cardiac safety units and specialized functional testing (driving simulation, imaging).
Method development, transfer, validation and sample analysis for small and large molecules using LC‑MS/MS, ligand‑binding, PCR and other specialized assays; high monthly throughput and assay repository support.
Formulation development, scale‑up from prototype to commercial manufacturing, clinical supply and packaging, with environmental monitoring and controlled‑substance handling.
Preparation of SEND‑compliant datasets, define files and Study Data Reviewer’s Guide; interim and final dataset delivery, validation and QC, and conversion of third‑party data into SEND format.
CRF/eCRF design aligned to CDASH, database build and validation, data cleaning, medical coding, SAE reconciliation and formatted data transfers per sponsor specifications.
Expertise Areas
- Early‑phase drug development (lead selection to proof‑of‑concept)
- Phase I clinical site operations and inpatient unit management
- Preclinical safety and regulatory toxicology
- Clinical pharmacology and early‑phase study execution
Key Technologies
- Liquid chromatography–tandem mass spectrometry (LC‑MS/MS)
- Ligand‑binding assays
- Polymerase chain reaction (PCR) assays
- Flow cytometry
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