A CRO THAT LISTENS TO YOUR NEEDS
Altasciences offers our sponsors a simplified pathway for drug development programs, from lead candidate selection through to early stage clinical trials. Our outsourcing platform enables biotechnology and pharmaceutical companies to work with a single partner to develop molecules through to human proof of concept.
The involvement of our clinical team does not start when the preclinical development is over. In fact, our Program Managers involve our clinical pharmacologist and other study design experts on an on-going basis as the preliminary results of the safety assessment studies are running. Altasciences can therefore offer a comprehensive full service package which minimizes hand-offs throughout the process, resulting in faster timelines.
Why Choose Altasciences?
By working with Altasciences, you have access to scientific and operational experts for input into protocol designs, interpretation of findings and strategic options, whether for a single study, preclinical program, clinical program, bioanalysis, or entire program from lead candidate selection to proof of concept.
If choosing to outsource an entire development program from lead candidate selection to proof of concept, you can work with ONE project manager. Clinical preparation is initiated during the preclinical phase, thereby proactively adjusting timelines from one key drug development milestone to the next.
You will benefit from the experience of our bioanalysis department to support both preclinical and clinical phases of development and have access to expert scientific input.
We are continuously looking for ways to improve our relationships and range of services to provide value for our customers. We believe in transparency, responsiveness, and the importance of being dependable.
Altasciences Clinical Pharmacology Testing
Altasciences is one of the largest early phase clinical development organizations in North America, with clinics in both the U.S. and Canada, offering our clients comprehensive clinical pharmacology services, including supporting research services. Experience gained over 25 years allows the team to design, conduct, analyze and report on all types of clinical pharmacology trials.
Altasciences has conducted first-in-human studies that cover a broad range of therapeutic areas in either small or large molecules and has expertise in multiple routes of administration. Almost half of the trials we conduct include a proof-of-concept component which ranges from measuring biomarkers in healthy participants or patients, to imaging, disease models or symptom assessment.
Our robust participant database enables us to dose every cohort on time, even when dose escalations are a week apart. Our upscale facilities combined with our focus on participant comfort lead to industry leading retention rates.
Our clinical services include expertise in:
- First in Human (FIH)
- Single Ascending Dose (SAD)
- Multiple Ascending Dose (MAD)
- Proof-of-Concept
- Bioavailability (BA)/Bioequivalence (BE)
- Food Effect
- Age Effect
- Gender Effect
- PK/PD
- PK in Special Populations
- Drug-Drug Interaction (DDI)
- Bridging Studies
- Comparative Bioavailability and PK Studies
- 505(b)(2)
Specialties include, but are not limited to:
- Biologics/Biosimilars
- Infectious Diseases
- Human Abuse Potential (HAP) with New Chemical Entities and Abuse-Deterrent Formulations (ADF)
- Substance Use Disorders
- Metabolism and Endocrinology
- NAFLD/NASH
- Type I and II Diabetes
- Obesity
- Renal and Hepatic Impaired
- Pain Models and Inflammation
- Topical Vasoconstrictor and Irritation-Sensitization
- Cognitive Testing
- Driving Simulation
- Imaging
- QT Assessment
- Cannabis