Clinical Trials
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.
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.