Clinical Trials
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.
Evaluation of CNS-Active Drugs for Worldwide Submission
In this complimentary webinar, Dr. Beatrice Setnik and Dr. Andy Mead take a comprehensive look at the key differences between the EMA and FDA drug development requirements when evaluating CNS-active drugs for abuse potential, as well as the need for a controlled substance designation.
Questions? Speak with our scientists.
You may also be interested in the following:
- Podcast: Altasciences' Scientific Experts Discuss Safety Pharmacology
- Webinar: Navigating Early Phase CNS-Active Drug Development
- Fact Sheet: Driving Simulation Studies
- 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.
Ethnobridging Supports Global Clinical Development
In our February 2021 blog we discussed protocol design concepts for ethnobridging in Phase I clinical trials.
The Brain on Drugs ― a Discussion with Neuroscientist Dr. Denise Milovan
This on-demand webinar focuses on the importance of including biologic and cognitive pharmacodynamic markers in your early phase clinical trials.
Presenters Dr. Beatrice Setnik and Dr. Denise Milovan unpack:
- Strategic information collected through targeted cognitive markers
- How cognitive endpoints guide the design of clinical trials
- Specialty studies to help make informed clinical development decisions
- Why include biomarkers in early phase trials, including neurology and inflammation
To learn more about our CNS-driven solutions, speak with our experts.
You may also be interested in the following:
- Webinar: The Many Facets of Early Phase Evaluation of Psychedelics in Psychiatry
- The Altascientist: Maximizing Drug Formulation for First-in-Human Trials
- Webpage: Human Abuse Potential Capabilities
- Fact Sheet: Bioanalytical Services
- Video: Altasciences ― Fully Integrated Drug Development Solutions
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.
Have you Considered Microsampling for your ANDA Submission?
Have you seen the recent FDA guidance confirming the possibility of using microsampling for PK sampling in ANDA trials? Please refer to Section 3c, page 11 of the guidance entitled Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.
Altasciences’ leadership and expertise in the field of microsampling is unparalleled, including preclinical collection, clinical collection and self-sampling, and bioanalytical method development using a variety of microsampling techniques and devices.
You may also be interested in the following:
- The Altascientist Scientific Journal: Microsampling
- Fact Sheet: Microsampling in Early Phase Drug Development
- Blog: Leveraging the Benefits of Microsampling for Safety and Convenience
- Video (two minutes): Microsampling
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.
Options and Opportunities for Safety Pharmacology Studies
Help guide the safe performance of clinical trials through design and conduct using thorough data from safety pharmacology studies.
Read The Altascientist Issue 13 – Safety Pharmacology Guidelines and Practices
Efficiencies in time and resources, as well as certain analytical advantages, can be realized by:
- combining safety pharmacology studies (i.e., cardiovascular and respiratory) where appropriate
- including safety pharmacology endpoints in general toxicity studies
You may also be interested in the following:
- Brochure: Safety Pharmacology Capabilities
- Podcast: Altasciences’ Scientific Experts Discuss Safety Pharmacology (10 mins.)
- ICH Guidance for Industry S7A Safety Pharmacology Studies for Human Pharmaceuticals
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.
Take a Virtual Tour of our State‑of‑the‑Art Clinical Laboratories
With over 25 years’ experience in clinical pharmacology, our experts provide comprehensive drug development solutions to get your molecule to clinical proof of concept. Our experienced team can guide you in the design and conduct of your studies in a wide range of therapeutic areas, including small molecules, biologics, 505(b)(2) and hybrid applications.
Combined, our clinical pharmacology units total 130,000 square feet and feature:
- Over 500 beds
- 10 on-site driving simulators
- On-site pharmacies
- Long-term stay facilities
- Upscale amenities for participants
- Outpatient and return units
- Participant screening facilities
- 24/7 security
Catch a glimpse of the facility here.
Request a full virtual tour of our clinical facilities or contact us for more information.
You may also be interested in the following:
- Webpages:
- Webinar: The Strategic Use of Cognitive Measures and Biomarkers in Early-Phase CNS Drug Studies
- The Altascientist: Central Nervous System Active Drugs ― Complex Considerations
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.
Don’t Miss it ― a Regulatory Discussion with our Experts
Complimentary Webinar — Clinical Trials in Support of a U.S. Drug Submission
Did you know that first-in-human (FIH) clinical trials conducted in Canada can accelerate regulatory approvals from the EMA and the U.S. FDA?
For an overview of foreign health authority requirements for approval to conduct a FIH clinical trial, including a comparison of Health Canada’s and the EMA’s Clinical Trial Authorization (CTA) processes and the U.S. FDA’s Investigational New Drug (IND) submission process, watch this complimentary webinar.
Topics covered include:
- Ensuring timely FIH clinical trials when planning your early phase drug development strategy
- Utilizing foreign clinical trials for U.S. FDA drug submissions and approvals
- Differences in the quality and nonclinical data submission requirements to gain EMA, FDA, and Health Canada approval to conduct FIH trials
Contact us to discuss the additional benefits of conducting FIH trials in Canada.
You may also be interested in the following:
- Webpage: Scientific, Regulatory, and Strategic Guidance
- Fact sheet: Clinical Sample Collection Kits
- Fact sheet: First-in-Human (FIH) Studies
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.