Clinical Trials
Comprehensive Solutions for Your First-in-Human Trials
A Partner You Can Trust
Altasciences has decades of experience designing, conducting, and reporting on first-in-human (FIH) clinical trials. Simple or complex, we have the expertise, purpose-built Phase I facilities, and seamless processes to deliver quality with speed and ease. Benefit from our customized approach, including clinical pharmacology units and integrated, state-of-the-art bioanalytical laboratories in the U.S. and Canada, along with the full range of complementary services.
Have a look at these resources to learn more:
Maximizing Drug Formulation for First-in-Human Trials
Planning Your First-in-Human Trial
Have questions? Contact our experts today.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
You have questions; we have answers.
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To You, With Science - Our Latest Audiobook Releases
Listen to the Latest Audiobook Releases of The Altascientist
Delve deeper into the critical processes behind early phase drug development with audio versions of The Altascientist, written by our experts with you in mind:
Issue 31 — The Advantages of Conducting Early Phase Clinical Research in Canada | Issue 32 — A Changing Paradigm for Non-rodent Species in Nonclinical Safety Studies |
Issue 33 — CNS Drug Development: Integrated Solutions Lessen Complexity | In Case You Missed It: |
[NEW PODCAST] Exploring the FDA's Draft Guidance on Psychedelic Drug Research
Unlocking New Horizons
The FDA recently published a first-ever draft guidance on clinical development requirements for psychedelic drugs.
Join Altasciences’ panel of experts as they provide an in-depth review of the guidance and valuable insights into the areas where further methodological adaptations to study designs may be necessary. These adaptations play a pivotal role in accurately assessing the safety, pharmacology, and efficacy of groundbreaking psychedelic compounds developed for specific medical applications.
You may also be interested in the following:
• Webpage: CNS Drug Development Solutions
• Scientific Journal: Challenges Associated with Schedule I Therapeutic Development
• Webinar: Practical Approaches to Conducting Early Clinical Trials with Psychedelics
Gain 6 to 9 Weeks by Conducting Trials in Canada
Taking full advantage of Canada's favorable regulatory landscape, Altasciences’ clinical facility in Montréal continues to be a popular choice, successfully completing hundreds of clinical trials each year.
In this issue of The Altascientist, we discuss the distinct benefits of conducting early phase clinical research on novel compounds in Canada versus other countries.
We cover:
• Canadian CTA trials–time and cost savings
• regulatory review process predictability
• business efficiency cost savings
• clinical trial participants
• Canadian CTA frequently asked questions
You may also be interested in the following resources:
Webpage: Altasciences' Three Clinical Trial Facilities
Videos:
- Accelerate Your Data With Altasciences’ Co-located Clinic and Lab
- Canada’s Regulatory Requirements for CTA Filings
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programmes, to offer an integrated/synchronised approach to CRO and CDMO services.
An Overview of Health Canada's CTA Process
Watch this podcast in which Altasciences' regulatory experts share key insights on Health Canada's Clinical Trial Application (CTA) regulatory submission process, including answers to your most common questions.
Altasciences’ Canadian clinical facility consists of seven Phase I units. We conduct over 100 trials every year in Canada, and support the full range of first-in-human studies, specialty studies, and therapeutic areas, such as ophthalmology, CNS, and substance abuse.
Take five minutes to explore these insightful resources:
Accelerating Global Drug Development Timelines With Ethnobridging
Safe Strategy to Save Time and Money
Avoid repeating Phase I studies for drugs intended for the Asian market. Altasciences has the clinical capabilities to demonstrate the biosimilarity of drug products between Asian and non-Asian populations by comparing the pharmacokinetics of the investigational drug in both ethnic groups, providing a safe strategy to save time and money.
Key resources for ethnobridging in Phase I clinical trials:
In this issue of The Altascientist, we demonstrate how ethnobridging can prevent the need for region-specific development programs, helping you safely achieve commercial milestones more efficiently. Download your copy today.
In this complimentary webinar, Mel B. Affrime, PharmD, Executive Vice President, Translational Medicine, discusses how ethnic differences can impact the bioavailability of your drug candidate and how to design a multiregional clinical development program to hasten worldwide regulatory approval safely. Watch the webinar.
Speak with an expert today to discuss your next clinical program.
You may also be interested in the following webpages:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Contract Pharma: Regulatory Affairs—Accelerating Drug Development Timelines
Selecting the Right Pain Model for Your Study
Experience You Can Count On
With over 25 years of experience, Altasciences offers pain stimulation models and pharmacodynamics tests for early phase analgesic trials. These tests provide critical data for informed decision-making. Our team of pain experts and neuroscientists is here to assist you in selecting the most appropriate pain model to successfully evaluate your study drug's efficacy and safety profile.
Discover how we can deliver the solutions needed for your pain research.
You may also be interested in the following resources:
• Webinar: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-Active Drugs
• Pain Model Poster: Inside the Pharmacodynamic Toolbox
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
CANADA: A Game Changer for First-in-Human Trials
Get Ahead of the Competition
Looking to take your ex-U.S. strategy to the next level? With a state-of-the-art clinical facility in Canada, Altasciences has the capacity and decades of expertise to submit your CTA six to nine weeks earlier than an IND.
We can help get you into the clinic faster—schedule a chat today!
Must-watch videos:
Co-located Canadian Ophthalmology Center for All Your Early Phase Development Needs | |
Accelerate Your Data With Our Canadian Co-located Clinic and Lab | |
Montréal Clinic Mini Tour |