End-to-End Program

  • End-to-End Program
  • Not Your Average CRO/CDMO

     

    Our Commitment to You

    Your new drug could be the one that changes someone’s life. As investors in life sciences, we know that each project matters. Whether you place one study or multiple programs with us, we treat each project with the equal care and dedication it deserves, no matter the size or spend. 

    We are committed to making your project a success. After all, your success is our success. And our success, together, means getting better drugs to people who need them, faster.

    Speak with an Altasciences expert today

    TAKE FIVE:


    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development 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.

    Bioanalytical Scientific Guidance from Discovery to Preclinical to Phase IV

     

    From discovery to preclinical to Phase IV, Altasciences’ bioanalytical team of over 260 scientific experts specialized in bioanalysis, ligand binding assays (LBA), mass spectrometry, immunology, biomarkers, flow cytometry, and PCR, operates in three strategic locations in proximity to our preclinical and clinical sites. We aim to provide top quality data for TK, PK, and PD determinations to support your preclinical and clinical studies.   

    At Altasciences, One Laboratory Sciences moves in unison for the success and acceleration of drug development.

    Let’s schedule time to discuss your bioanalytical needs.


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    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development 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.

    Top Scientific Resources of 2021

    Top Scientific Resources of 2021

    With the year coming to an end, we rounded-up some of our most insightful scientific resources from 2021. Check out what you may have missed, discover more about our areas of expertise, and learn how we can help you accelerate your drug development program.

    Preclinical
    1.





     
    The Altascientist: Planning your Preclinical Assessment for a Successful Regulatory Submission
    A thorough review of IND requirements and preclinical program considerations, including a guide to help you estimate small molecule and biologic timelines.
    Read More
     
    2.



     
    The Altascientist: Safety Pharmacology Guidelines and Practices – A Review
    How to reduce the use of test animals, save time, and ensure quality data. Read More
     
    3.




     
    Podcast: Consultant Series ― A chat with Dr. John Atkinson, Founder of Atkinson Toxicology Consulting
    Dr. Atkinson’s journey in the drug development industry, his experience as the former president of the American College of Toxicology, what to look for in a CRO partner, and much more. Listen Now
    Clinical
    4.


     
    The Altascientist: Planning your First-in-Human Trial
    A thorough review of the first-in-human clinical trial process, including planning and conduct. Read More
     
    5.



     
    Blog: Ethnobridging Supports Global Clinical Development
    Historical background on ethnobridging and how it developed into a mainstream strategy. Learn More
     
    6.




     
    Webinar: The Brain on Drugs: The Strategic Use of Cognitive Measures and Biomarkers in Early-Phase CNS Drug Studies 
    Key clinical and bioanalytical considerations when it comes to pharmacokinetics and pharmacodynamics data specific to biologics. Watch Now
    Manufacturing
    7.




     
    E-Book: Liquid-Filled Capsules: Getting Your Drug to the Clinic – FAST
    How liquid-filled, hard-shell capsules can help accelerate drug development programs and entry into clinical trials. Read More
     
    8.




     
    The Altascientist: Terminal Sterilization of Pharmaceutical Products
    Why regulatory agencies, such as the FDA and EMA, prefer terminal sterilization over aseptic processing. Learn More
     
    9.


     
    Webinar: Overcoming the Challenges of Manufacturing and Clinical Trials
    An overview of our pharmacy and manufacturing services, including a recent case study. Watch Now
    Bioanalytical
    10.





     
    Webinar: Patient Centricity and the Evolving Role of Microsampling
    An in-depth bioanalytical and clinical exploration of microsampling technology and its significance in supporting patient-centric healthcare initiatives, along with case studies to demonstrate.  Watch Now
     
    11.




     
    Insert: Flow Cytometry Solutions to Support your Preclinical and Clinical Studies
    An overview of our flow cytometry services, on-site equipment, flow markers, and NHP panels to support your preclinical and clinical studies. Read More
     
    12.



     
    Infographic: The Key To Selecting The Right Bioanalytical Platform For Your Molecule
    How to expedite your research goals by proactively selecting the best pathway for your unique molecule. Learn More
    Research
    13.




     
    Quick Chat: A Seamless Experience, Thanks to Expert Scientific Project Management
    An inside look at Altasciences' Scientific Project Management team, our company culture, and how we assign project and program managers. Watch Now
     
    14.


     
    Webinar: Demystifying the CTA Process in Canada
    Benefits of conducting FIH trials in Canada for biopharmaceutical companies. Watch Now
     
    15.



     
    Interview: Five Things to Know About Scientific Affairs
    Catherine Dussault, Director of Scientific Affairs, discusses how her team is able to design and conduct the most appropriate study for each unique development program. Read More

    Have five more minutes? You may be interested in:


    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development 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.

    Start Your Clinical Trials Sooner

     

    Our clinical trial experts set your drug development program up for success by proactively preparing and performing each critical moving part while others are underway. As a single source for early phase drug development solutions, we integrate and synchronize key CRO/CDMO activities, such as clinic-ready manufacturing, bioanalysis, clinical study conduct, and regulatory review, so that you’re always ready for the next step.

    Check out how we do this and experience the difference.  

    Clinical Trial: Faster, easier, proactive

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    Webpages:

    Fact Sheet:

    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.

    Let’s Talk Integrated Clinical and CDMO Solutions

     

    Quality and Excellence with Integrated Clinical and CDMO Solutions

    Shawn Connaghan, Executive Vice President of Administration and Quality Management, Manufacturing, discusses how Altasciences’ integrated manufacturing and clinical solutions can benefit your drug development program. 

    Topics covered:

    • Advantages of integrated manufacturing and clinical solutions
    • Quick project start-up
    • Maintaining high-quality standards
    • Adapting to sponsors’ unique needs

    WATCH NOW

    Quick Chat with Shawn Connaghan, Executive Vice President of Administration and Quality Management

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    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.

    Expert Support for Your IND/CTA Requirements

    Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least six months before your required submission date.

    Contact our experts today.

    Altasciences can help you compile the key information necessary to approve your application request, including:

    • Animal pharmacology and toxicology studies to assess safety
    • Manufacturing processes to ensure consistent batches of the study drug
    • Clinical protocols and investigator information to assess tolerance and risk

    For a more detailed discussion of the regulatory planning process, consult our Preclinical Assessment Planning Guide.

    Altasciences’ Proactive Drug Development platform transforms the traditional outsourcing paradigm by providing you with expertly designed, customized roadmaps that seamlessly bring you from lead candidate selection to clinical proof of concept, and beyond.

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    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.

    Contact us

    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.

    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:

    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.

    Overcoming Challenges and Building a Successful Company

     

    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

    Overcoming Drug Development Pathway Challenges with FirstString Research CEO Dr. Gautam Ghatnekar

    You may also be interested in the following:


    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):

    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:

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