Industry Expert Talks First-In-Human and Complex Clinical Trials
A Chat with Dr. Morelli
Altasciences has decades of experience designing, conducting, and reporting on early phase clinical trials. We have the scientific expertise and seamless operational processes to deliver quality data with speed and ease.
Watch as Dr. Morelli, Chief Medical Officer, shares his first-hand experience and insight into Altasciences’ planning and conduct of your first-in-human, complex, and innovator clinical trials.
Want to know more? Speak with an expert about your FIH and other clinical research needs.
You may also be interested in the following:
Webpages:
- First-In-Human Clinical Trials
- Comprehensive Early Clinical Development Solutions
- Altasciences’ State-of-the-art Clinical Trial Facilities
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.
June 2022
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Our Altascientists are hard at work, whether it’s on your drug development projects, or producing insightful scientific resources to share their knowledge with you. Catch up on what you may have missed, or revisit some highlights from the last three months. |
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A Message from Our CEO to You News: Altasciences Receives CRO Leadership Award in All Five Categories! eBook: One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs Blog: The Impact of Social Factors on Drug Development |
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Five New Scientific Posters Presented at SOT 2022:
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Blog: Five Facts About Psychedelics for Mental Health Quick Chat: Experts in Complex Clinical Trials (with Dr. Morelli, MD) On-Demand Webinar: Inside the Pharmacodynamic Toolbox On-Demand Webinar: Ethnobridging in Phase I Clinical Trials |
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Quiz: Test Your Knowledge of Liquid-Filled Capsules Case Study: Rapid Development of a Liquid-Filled, Hard-Shell Capsule Formulation of Cannabidiol Podcast: Episode #24 ― The Importance of a CDMO Consultant Quick Chat: Manufacturing and Handling Your Highly Potent APIs and Controlled Substances (with Ben Reed) |
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eBook: Key Biomarkers of Immunomodulation ― Complement Factors and Cytokines Poster: Parallelism Challenges When Using Commercial Kits for Biomarker Quantitation |
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Scientific Journal: Issue 23 — Robust Sample Management for Reliable Study Results Unboxing Video: What’s Inside Altasciences’ Clinical Sample Collection Kit? Blog: Q&A with Dr. Nicole Maciolek — Setting Up Your Clinical Research for Success |
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Scientific Publication Guidance and Development
Scientific Publication Writing — Let Us Help!
Altasciences’ scientific experts can provide you with strategic guidance and quality writing for your next scientific publication, writing for a wide range of therapeutic areas, for your preclinical to clinical research — as part of a full-service program completed at our facilities or as a stand-alone offering.
Benefit from:
- Strategic publication guidance and content development for manuscripts, posters, and abstracts
- Expert review and editing of your pre-written publications
- And more!
Have 5 minutes? You may be interested in:
- Comprehensive Research Support Capabilities
- Scientific, Regulatory, and Strategic Guidance
- Full-Time Equivalent Capabilities
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.
Future Science: Diversity and Inclusion in the Bioanalytical Industry — An Interview with Anahita Keyhani
NEW SCIENTIFIC PUBLICATION — Achieve Robust and Accurate Study Results
Robust Sample Management
Read our latest issue of The Altascientist to better understand how we deliver reliable study results through robust sample management for your preclinical and Phase I to IV clinical studies, including:
- Customized processes
- Controlled environments
- Standardized workflows for risk management
- Capability to handle a wide variety of matrices
- Stability testing
Download your copy, or listen to the audiobook today.
You may also be interested in the following:
Webinars:
- Sample Collection Kits and Lab Manual
- Bioanalytical Project Management
- Critical Sample Handling Processes for Clinical and Preclinical Studies
Podcast:
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.
Test Your Knowledge of Liquid-Filled Capsules
Thanks to updated screening methods and bioavailability enhancements, poorly soluble molecules comprise 70% to 80% of the small molecule products entering the drug development pipeline today. Since poorly soluble drugs are difficult to formulate as tablets, formulation scientists are looking to two-piece, liquid-filled hard-shell capsules as a solution.
Methodological Considerations for the Human Abuse Potential Evaluation of Emerging Drug Therapies with Psychedelic Properties
FDA Says Use Terminal Sterilization Over Aseptic Manufacturing. Find Out Why.
Terminal sterilization is the most effective way to reduce the chances of microbial contamination and provides a higher level of sterility assurance to finished drug products. It is also less complex, less costly, and more easily reproducible than aseptic manufacturing.
Discover the full range of benefits by viewing the webinar on-demand.
Topics include:
- Differences between aseptic processing and terminal sterilization
- Common misconceptions about terminal sterilization
- Preferences and expectations of regulatory agencies
- How to evaluate your product’s compatibility
Case study also included!
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.
The Reality Behind Schedule I Therapeutic Development
Altasciences Tackles the Issues and Challenges Associated with Schedule I Therapeutic Development
Schedule I, or Class I (CI) drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse. Recent research on psychedelics and entactogens, of which are schedule I, is beginning to demonstrate potential therapeutic effects of these drugs for various medical indications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status.
In this issue of The Altascientist, we uncover the following:
- Regulatory environment and challenges — DEA
- Required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs
- Manufacturing considerations
For novel CNS-active Schedule I drugs, partner with Altasciences and benefit from our Schedule I licenses across every stage of early phase drug development. Our knowledge and operational expertise across preclinical, clinical, and manufacturing stages ensures complete continuity, data transfer, information sharing, and efficient timeline management... in real-time.
Speak with an expert today for more information or to review your specific program requirements.
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.