Choosing the right CRO/CDMO for your first-in-human (FIH) trials enables you to run a successful study that generates high-quality data with speed and ease.

With nine facilities across North America, explore our integrated, comprehensive solution for all your early-phase drug development needs and unique expertise.

Discover how we accelerated a Phase 1 study’s start-up time by 70%! This case study shares insights on streamlining communication, strategic planning, and more.

This FAQ list offers clarity on pivotal aspects of your drug development journey, ensuring studies in Canada pave the way for U.S. FDA and EMA submissions.

Sponsors always ask, “Will the partnership save me time and money?” and “How can you streamline the complex development processes for me?” Get the answers to these questions and more.

By completing your trials in Canada, you can accelerate your early phase clinical research by six to nine weeks compared to an IND submission in the U.S.

Understand the conduct of clinical trials in Canada and learn five key reasons why you should choose Canada for your next trial.

Why wait? We begin planning your clinical study while your preclinical safety assessment is ongoing to start your first-in-human trials sooner.

As pharmaceutical and biotechnology companies become increasingly dependent on contract research organizations (CROs) to spearhead their preclinical and clinical research programs, choosing the right partner is more important than ever.

Overcome challenges and complexities in ophthalmic drug development by partnering with an integrated CRO/CDMO provider with extensive regulatory knowledge and scientific expertise.

From the initial preclinical data, read why the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population.

From prototype formulation through preclinical testing, early phase clinical and manufacturing and development, ophthalmic drug development presents with specific and unique complexities.

Combining certain Phase II studies with the Phase I protocol gives you earlier access to data, enabling more informed go/no-go decisions early in the program.

A Phase 1 ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases 2 and 3) without repeating Phase 1 development in that region and population.

Gain insight into why a first-in-human (FIH) clinical trial is a significant milestone in the development of a potential new drug.

In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development.

Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone. Check out this eBook for your roadmap to successfully conducting FIH studies.

Find out why electrocardiography (ECG) is an integral part of the new drug regulatory environment.

Read how drug-drug interactions (DDIs), as well as drug-alcohol or food effects, are examples of how extrinsic factors can alter the exposure of drugs and cause serious adverse effects or a reduction in efficacy.

Like the Hybrid medicine authorization process in the EU, the 505(b)(2) NDA approval process in the USA applies to generic molecules that have a slight change from the reference medicine, and can use published data.

Altasciences offers a unique approach that can lower your costs and reduce program timelines from lead candidate selection to clinical proof-of-concept by up to 40%.

This session gives an overview of the recently published draft FDA guidance on psychedelics and how to efficiently adapt the recommendations for early phase clinical development.

Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.

In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.

Watch this video in which Altasciences’ regulatory experts share key insights on Health Canada’s Clinical Trial Application (CTA) regulatory submission process.

Discover the crucial insights and methodological adaptations needed to effectively assess the safety, pharmacology, and efficacy of innovative psychedelic compounds designed for specific medical applications.

Dr. Beatrice Setnik, Altasciences' Chief Scientific Officer, walks through the differences between early and late QT prolongation testing.

Dr. Beatrice Setnik, Chief Scientific Officer at Altasciences, discusses tactics for a successful clinical development pathway for CNS-active drugs.

Altasciences and Sygnature Discovery discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs.

Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.

This session explores the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy evaluation of a CNS-active drug in early clinical trials.

Learn how ethnic differences can impact the bioavailability of your drug candidate and strategies for the design of your multiregional clinical development program.

Experts examine the preclinical, clinical, and regulatory requirements and strategies that second generation psychedelics may utilize to differentiate their pharmacological profile.

Delve into a unique perspective around the behaviors of opioid and stimulant drug abuse.

Drug development in the ocular space has specific challenges. Explore how an end-to-end solution can facilitate a path to Phase 2.

Discover how having early access to trial results and data can help to make inform decisions later in the development journey, support funding opportunities, and help solidify plans around sound data.

Discover how local ethnobridging studies during Phase I can reduce drug development timelines by the number of years typically needed to complete clinical development in a target region.

Dr. Beatrice Setnik, Chief Scientific Officer at Altasciences, discusses the drug and vaccine development process to provide insight on the typical timelines for getting a vaccine to market.

Learn about best practices and approaches in Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission.

Learn why drug addiction is a devastating condition that affects the quality of the user and their families.

Explore the behaviors of individuals who abuse opioids and stimulants, and learn about their patterns of use and motivations to compel them to continue using these drugs.

Schedule I, or Class I (CI) drugs are currently restricted to research in the U.S. Explore the challenges associated with Schedule I therapeutic development.

A first-in-human clinical trial is a significant milestone in the development of a potential new drug. Listen and learn how to plan your first in-human clinical trial.

In this issue, review complex considerations for the development of central nervous system-active drugs, including the Controlled Substances Act, preclinical and clinical data requirements, and additional assessments your program may need.

First-in-human (FIH) trials in the early phases of drug development represent a critical milestone in the approval of medicines.

Listen to this discussion on global regulations, design, and timing of QT assessment, including a case study from a first-in-human clinical trial.

Discuss effective pharmaceutical therapies, specifically, understanding the intrinsic and extrinsic factors that alter exposure to limit adverse effects and maximize treatment response.

Learn why hybrid medicines require re-approval for market authorization, partly based on data from the original reference medicine, and partly on data from new clinical trials on the modified version.

Metabolic disorders can take many forms, with obesity and diabetes being the most common. Once considered a high-income country problem, learn why obesity is now on the rise even in low- and middle-income countries.

In this issue, explore key considerations for biosimilar clinical pharmacology studies.

In this issue, dive into HAP studies, and the importance of an exert drug development solution partner in human abuse potential.

When a sponsor wanted to conduct a first-in-human test on a cannabis extract being studied for use in breakthrough cancer pain, discover the collaboration on the ideal development plan.

With more than 6,800 FDA-approved drugs, it is crucial to put in place a systematic effort to identify the drugs that increase the risk of motor vehicle accidents.