Clinical Trials
The Many Faces of Recreational Drug Use
The Issue of Opioid aBUSE
A growing public health concern, opioid abuse has been intensified by the COVID-19 pandemic.
Tailored Analytical Solutions for Fast Entry into Clinical Trials
Choosing the Right Partner for Your Formulation Needs
Altasciences’ extensive formulation and manufacturing services, integrated with our early phase drug development offering, spans across the full drug development pathway, from discovery through commercialization. Our scientists have decades of expertise with both simple and complex dosage forms, and a successful track record of formulating molecules and developing the drug products required to support early phase clinical trials.
Discover our full range of analytical services, including:
- Drug product release and stability testing
- Method development, qualification, and validation
- On-site, ICH stability storage and testing
Get a head start on your project ― speak with one of our scientists.
You may also be interested in the following:
- Webpage: Pharmaceutical Contract Manufacturing Services
- Webinar: Overcoming the Challenges of Manufacturing and Clinical Trials
- Webpage: Clinical Trial Services
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Clinical Assessment of Potential Cardiac Risk for Your Drug
The thorough and precise evaluation of cardiac effects is a critical element of new chemical entity development. You can choose to add early cardiac safety assessment to your first-in-human studies, or wait and perform a Thorough QT prolongation study; either way, we can help you with the study design and conduct.
In this educational video, Dr. Beatrice Setnik, Altasciences’ Chief Scientific Officer, walks you through the differences between early and late QT prolongation testing.
Speak with our experts today for help in deciding between early and late QT prolongation testing.
You may also be interested in the following:
- Webpage: QT Assessment
- Fact Sheets:
- The Altascientist: Cardiac Clinical Trials, Global Regulatory Requirements, Design, and Timing of QT Assessment (Case Study Included)
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Determining if a HAP or ADF Assessment is Needed
Investigating the Abuse Potential of your CNS-Active Therapeutic
The FDA Guidance, Assessment of Abuse Potential of Drugs, states:
Drug products with abuse potential generally contain drug substances that have central nervous system (CNS) activity and produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants. Thus, if a drug substance is CNS-active, the new drug product containing that drug substance will likely need to undergo a thorough assessment of its abuse potential…
The results of a human abuse potential (HAP) trial can indicate that your product will need an abuse-deterrent formulation (ADF), or specific labelling. Altasciences’ scientific, regulatory, and clinical experts will work with you to design a roadmap for your HAP evaluation program.
HAP trials are procedurally intense, requiring high levels of skill and experience, secure clinical facilities with the necessary licenses, and pharmacy capabilities and expertise to ensure appropriate handling and storage of the drug products.
For a more in-depth look at the requirements and implications of HAP trials for your drug development program, consult The Altascientist — Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs.
Speak with an expert today for more information or to review your specific program requirements.
Related Resources:
Webinar: To Control or be Controlled – Navigating the Abuse Potential Evaluation of CNS-Active Drugs for EU and US Submissions
Scientific Poster: Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse, Dependence, and Impairing Effects of CNS-Active Drugs in Healthy Volunteer and Patient Trials
Webpage: Human Abuse Potential
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
We Deliver Your Projects On-Time.
On-Time Delivery
Over the last 12 months, our project management team has played a key role in achieving a 99% on-time delivery success rate on your primary KPIs.
Altasciences’ high-quality project management is key to the success of your drug development programs, and is an integral part of our service offering. Our project management team has extensive expertise in managing studies for a wide range of therapeutic areas in small and large molecules, and will oversee every aspect of your study.
Partner with us to ensure seamless and timely communication for the successful completion of your project.
You may also be interested in the following:
Webpages:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Up Close and Personal with Dr. David Nguyen, MD, MBA
Dr.
Flow Cytometry Solutions to Support Your Preclinical and Clinical Studies
Altasciences’ offers scalable flow cytometry solutions, and leverages extensive knowledge to help ensure a smooth transition from preclinical to clinical studies. We provide you with:
- Dedicated flow cytometry scientists available to you early in the process to help determine the most appropriate strategy for non-GLP, GLP, and GCP testing
- Extensive knowledge with exploratory and GLP studies from panel development to validation
- Design and development of receptor occupancy (RO) assays
- Strategically located laboratories in both the U.S. and Canada.
- State-of-the-art instrumentation
- Rapid turnaround between sample collection and analysis
Altasciences has the same instrumentation in its U.S. preclinical site and Canadian site, which allows assay transfer for easy transition from preclinical to clinical studies.
Download flow cytometry fact sheet
Speak to a flow scientist for guidance on your assay development or validation strategy.
You may also be interested in the following:
- Webpage: Therapeutic Areas of Clinical Research
- Fact Sheet: First-in-Human Trials Capabilities
- The Altascientist: Facing Bioanalytical Challenges
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Altasciences’ Ethnobridging Solutions Safely Accelerate Drug Development
Clinical data generated by ethnobridging trials in Asian populations are meant to safely accelerate development timelines by evaluating:
- Efficacy
- Safety
- Dosage
- Dosing regimen
In Asia-Pacific countries, ethnobridging studies can reduce drug development timelines by four or five years ― the time it typically takes to complete clinical development in the region versus in North America or Europe.
Discover how you can reduce your drug development timelines.
You may also be interested in the following:
- Blog: Protocol Design Concepts in Phase I Ethnobridging Clinical Trials
- Fact Sheets:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Expertise to Support the Approval of your 505(b)(2) or Hybrid Drug Submissions
A generic molecule with a different route of administration, format, strength, or indication from the original reference product requires re-approval for market authorization, partly based on data from the original medicine, and partly on data from new clinical trials on the modified version.
Consult The Altascientist for a review of the requirements for such approval, including a case study outlining three key studies we conducted for a 505(b)(2):
Altasciences ensures a seamless process for your 505(b)(2) or Hybrid medicine submissions, with integrated manufacturing, bioanalysis and comprehensive research support services that can expedite your clinical trials.
Speak with our experts.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
You may also be interested in the following:
- Video (3 minutes): Fully Integrated Drug Development Solutions
- Fact Sheet: Multiple Award-Winning CRO
- On-Demand Webinar: Patient Centricity and the Evolving Role of Microsampling
Fast and Reliable Data for Your First-in-Human Trials
Data gathered during first-in-human (FIH) trials is critical to making go/no-go decisions in drug development. At Altasciences, we provide you with:
- Timely sample analysis and scheduling flexibility
- Rapid turnaround of PK/PD analysis between cohorts (within 48 to 72 hours)
- Excellent communication and information sharing between clinic and lab
- Early proof-of-concept signals
Our focus on early phase research, our integrated preclinical, clinical, manufacturing, and laboratory operations ensure data is shared with full transparency. PK analysis is built into your program schedule from the start, and dosage adjustments can be accommodated for safe and quick
decision-making.
Partner with us to get quality data you can rely on, fast.
You may also be interested in the following:
- Fact Sheets:
- Webpage: Pharmacokinetics/Pharmacodynamics Capabilities
- Podcast: Certificate of Analysis Essentials for Regulatory Bioanalysis
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.