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.

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. 

Download the Fact Sheet

You may also be interested in the following:

• Blog: Protocol Design Concepts in Phase I Ethnobridging Clinical Trials
• Fact Sheets:
  • Comprehensive Research Support Services
  • Bioanalytical 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.

Whether for a single study or a full drug development program, Altasciences can support you. We offer contract manufacturing and analytical services, including formulation development, Phase I through commercial manufacturing, and ICH stability testing.

Our integrated and synchronized approach to CRO and CDMO services, all under one organizational structure, can save you 25% to 40% in drug development time. 
 
Watch our Executive Vice President of Operations, Ben Reed, discuss our expertise in more detail.

Questions? Speak with an expert!

You may also be interested in the following:

• Web page: Pharmaceutical Contract Manufacturing and Analytical Services
• Webinar: Altasciences’ High-Potency Manufacturing Solutions
• Webinar: Altasciences’ Solutions with Liquid-Filled Capsules

Dr. Gautam Ghatnekar, CEO of FirstString Research, shares his secrets to raising capital, recruiting and retaining talent, and overcoming the challenges of getting medicines to the market.

Listen now

You may also be interested in the following:

• Article: Making Early Phase Drug Development Faster, Better, and More Efficient
• Podcast: Consultant Series ― Chat with Dr. John Atkinson, Founder of Atkinson Toxicology Consulting
• Scientific Publication: Assessment of Subcutaneous Radio-Telemetry Device Implantation in Cynomolgus Monkeys
• Webpage: Comprehensive 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.

As an alternative to traditional venipuncture, blood microsampling represents a less invasive and simplified collection technique, resulting in numerous benefits for preclinical and clinical studies alike.

Microsampling in safety testing supports Altasciences’ commitment to the 3Rs: replace, reduce, and refine experimental animal use. It also provides other advantages, such as:

• Accelerated animal recovery due to rapid blood collection
• Direct correlation of study findings with PD and toxicological effects given the use of main study animals 
• Less variability in PK profiles when derived from individual animals versus composite profiling  
• Collection of additional PK/TK timepoints
• Biomarkers and metabolites detection that aids interpretation of toxicological effect 
• Reduced animal numbers saves on costs and time

Speak with one of our microsampling experts today.

You may also be interested in the following:

• Webpages:
  • Microsampling Benefits
  • Preclinical Services
• Videos:
  • Altasciences’ Animal Welfare Program
  • Your Road to Proactive Drug Development with Altasciences

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.

If you are struggling with getting SEND data, Altasciences can help. Our personable and accessible SEND team is ready and able to answer your questions throughout your SEND process.

As an active member of the CDISC SEND Consortium and Pharmaceutical User Software Exchange (PhUSE) nonclinical working groups, Altasciences contributes to the development of SEND standards and remains at the forefront of these evolving requirements.

Contact a SEND expert today and start saving time.

You may also be interested in the following:

• SEND FAQs: Ask These SEND Questions First 
• Webinar: From Guides to Rules and How They Impact Your SEND Requirements 
• Scientific Publication: The FDA Animal Rule and Standard for Exchange of Nonclinical Data (SEND)
• Webpages:
  • Preclinical Solutions
  • Bioanalytical 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.

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