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.

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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

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.

Contact us

You may also be interested in the following:

• Fact Sheets:
  • First-in-Human Capabilities
  • Bioanalytical Services
• 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.

Altasciences’ analytical laboratory services teams support a full range of pharmaceutical and nutritional supplement testing capabilities, as stand-alone or as part of an integrated service offering, including:

• APIs, excipients, and packaging components
• Drug product release and stability testing
• Analytical method development, qualification, and validation
• On-site ICH stability storage and testing

Join our Executive Vice President of Operations, Ben Reed, on an exclusive virtual tour of our state-of-the-art analytical laboratory, and learn about the advanced equipment and techniques used by our scientists to ensure the quality and success of your drug development program.

Want a more in-depth virtual or in-person tour of our 64,000-square-foot manufacturing facility? Request one here.

Questions? Speak with an expert.

You may also be interested in the following:

• Webpage:  Pharmaceutical Contract Manufacturing and Analytical Services
• Fact Sheet: Pharmaceutical Analytical Services
• Webpage: Bioanalytical Services

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.

Trying to select the right bioanalytical platform for your molecule isn’t obvious. Altasciences’ team of scientific experts can help expedite your research goals by proactively advising the best pathway for your unique molecule.

Download this list of key considerations
for selecting the right bioanalytical platform.

You may also be interested in the following:

• Fact Sheets:
  • Ligand Binding Assays Capabilities
  • Bioanalysis of Small Molecules Using Mass Spectrometry
• The Altascientist: Microsampling in Drug Development
• Webinar: Quantitation of Passive Immunotherapeutic Agents for COVID-19 by LC-MS

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.

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.

Watch the webinar.

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:
  • Project Management
  • Tell Us Once™

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.