Clinical Trials
Inside The Altascientist: Nonclinical Dermal Study Considerations
An increasing number of advanced methods for dermal drug delivery contribute to successful 505(b)(2) applications and extend the patent life of a drug for its sponsor.
Development of the Subject-Rated Comprehensive Drug Withdrawal Scale (CDWS) to Evaluate the Physical Dependence Potential of Investigational Drugs
Pragmatic Considerations for the Application of Physical Withdrawal Assessments in Patient Studies
Discover Our Truly Integrated Clinical and Bioanalytical Solution
The True Meaning of Moving in Unison
Join our VP of Global Clinical Operations, Ingrid Holmes, and our VP of Laboratory Sciences, Lynne Le Sauteur, as they share the secrets to the success of our integrated clinical and bioanalytical solution. You won't want to miss this!
Watch the full interview or keep scrolling to jump to a specific section.
- Proprietary Scheduling System:
In this video, discover our game-changing, proprietary scheduling system, which is essential for hitting key client deliverables and managing internal milestones across departments and services with precision.
Explore more about our innovative scheduling system here. - Advantages of Being a Mid-Sized CRO:
Flexibility and customized service are at the core of our operations. Our mid-sized stature allows for seamless communication between departments while offering comprehensive services.
Discover the benefits of partnering with a flexible, mid-sized CRO here. - Successful Project Case Study:
In this interview, we highlight a real-world example of a challenging project where seamless communication and coordination, and the proximity of our lab and clinic were pivotal to exceeding client expectations and delivering outstanding results.
See how we tackle complex projects successfully here.
You may also be interested in the following webpages:
Selecting the Ideal Dosage Form for Your Drug Development Program
Choose Wisely.
With decades of experience developing and manufacturing almost every dosage form on the market, our experts can guide you in selecting the optimal one for your drug development program.
Read the infographic to discover the pros and cons of the two most popular solid oral dosage forms to determine which is best for your molecule.
Ready to discuss your drug development and manufacturing needs? Send us a message.
Related resources that may interest you:
- Webpage: Drug Development, Manufacturing, and Analytical Testing Services
- Podcast: Key Considerations When Formulating APIs for Preclinical Testing
- eBook: Applications of Liquid-Filled Hard-Shell Capsules in Pharmaceutical Development
Planning a First-In-Human Clinical Trial?
Unique FIH Solutions
for Small and Large Molecules
Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone. Our FIH solution provides a customized approach that is safe, and delivers quality data with speed and ease.
This eBook provides an overview of how our unique process can facilitate your early-phase clinical program:
• small molecule manufacturing experts quickly formulate your drug product and deliver it to the clinical site, ready for dosing;
• coordinated processes between our clinic and our bioanalytical labs;
• timed interim sample analysis for proactive dose escalation decisions and rapid turnaround of PK/PD analysis between cohorts;
• transparent communication between our teams and locations, and strict attention to early-phase timelines; and
• a database of over 400,000 normal healthy volunteers and strict safety protocols.
Access the eBook here to learn more.
Speak with one of our experts.
You may also be interested in the following:
Webpages:
• Phase I Clinical Trial Units
• First-in-Human Trial Capabilities
Scientific Journal:
• The Advantages of Conducting Early Phase Clinical Research in Canada
Top 5 Scientific Resources in CNS Clinical Trials
CNS Center of Excellence Resource Library
Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.
Here are some of our most insightful scientific resources in the area of CNS drug development:
Webinar: A Square Peg in a Round Hole–Navigating the Unique Attributes of Psychedelic Drug Development
Altasciences’ panel of experts discuss the FDA’s recently published guidelines for early-phase clinical development of psychedelics and the assessment of abuse potential. Watch Now
The Altascientist: Central Nervous System
Early-phase development of CNS-acting drugs is a complex, challenging undertaking.
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. Learn More
The Altascientist: CNS, Psychedelics, and Other Schedule I Drugs
In this scientific journal, we uncover the regulatory environment and challenges, the required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs, and the manufacturing considerations for CNS-active drugs. Learn More
The Altascientist: Studying the Effects of Drugs on Driving
Driving simulation studies are required by the FDA when preclinical and early clinical studies show that a drug may cause somnolence or impair cognition. Discover the challenges of driving simulation clinical testing. Learn More
The Altascientist: Human Abuse Potential Studies
The 2017 FDA guidance states that a broad range of CNS drugs require human abuse potential (HAP) studies to evaluate the abuse liability of drugs in development before a drug reaches the market. The complicated regulatory pathway for HAP requires individualized consulting for each type of study. Watch Now
Speak with an expert today to learn more about our CNS solution.
Have five more minutes? Check out these webpages:
• CNS Clinical Trials
• Human Abuse Potential<
• Driving Simulation<
First-in-Human Solution for Small and Large Molecules
Healing Hearts: A Journey of Compassion and Commitment
GETTING TO THE HEART OF SCIENCE WITH MARTA RODRIGUEZ
![Marta Rodriguez, Director of Clinical Operations at Altasciences](/sites/default/files/inline-images/Marta%20Rodriguez%20%282%29_preferred_500x500px.jpg)
At the heart of science are stories—stories of expe