End-to-End Program

  • End-to-End Program
  • 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

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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.

    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

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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.

    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:

    Scientific Project Management — We Lead With Your Priorities in Mind

     

    A Seamless Experience, Thanks to Expert Scientific Project Management

    From lead candidate selection to clinical proof of concept, whether for a single study or multiple programs, Altasciences’ Scientific Project Management team manages every study with your business priorities in mind.

    Join Lauren Szczurowski, Executive Director of Scientific Project Management, in this on-demand podcast as she reveals how Altasciences makes outsourcing early phase drug development a seamless experience.

    Quick Chat - Lauren Szczurowski

    Listen to Podcast

    Schedule a conversation with one of our Scientific Project Managers to review your questions and requirements.

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    Video — A Seamless CRO Experience 

    At Altasciences, our integrated, full-service solutions from lead candidate selection to clinical proof of concept are all customizable to your specific needs.

    Watch as Ingrid Holmes, Vice President, Global Clinical Operations, discusses how we help sponsors bring better drugs to market, faster.

    Contact our experts to learn more about our integrated drug development solutions.

    The Right Strategy for your Small Molecule Program

    Did you know that, in addition to large molecule work, Altasciences' preclinical team has extensive experience in designing and conducting safety assessment programs for small molecules? Our solutions meet all regulatory requirements, and include IND/NDA-enabling toxicology, safety pharmacology, and laboratory services in both rodent and non-rodent species.

    Choose Altasciences for your small molecule safety assessment program and let us guide you seamlessly through each milestone.

    The right CRO for your preclinical and clinical biosimilar studies

    Companies developing biosimilars are collaborating with us because of our firsthand preclinical and clinical experience, distinctive recruitment strategies and speed in conducting biosimilar studies that require a customized approach based on the therapeutic indication and study-specific goals.

    We have the scientific, toxicological, medical, and bioanalytical know-how to design studies that meet your objectives and timelines, manage any associated risks, and develop the methods required to analyze your product and its potential immunogenicity.

    How we help move your biosimilar programs forward:

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    Customized workflows using LC-MS/MS or Ligand Binding bioanalytical platforms for preclinical and clinical samples

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    Method development, GCP/GLP-compliant biosimilar assay development validation, and sample analysis for PK and immunogenicity/anti-drug antibody testing

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    Comparative general toxicity and PK studies in multiple species

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    Supplemental assessments such as for immunogenicity can be included in general toxicology study designs or as individual projects, depending on the nature of the test article

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    Ability to run multiple biosimilar programs simultaneously across our three clinical pharmacology units

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    Rapid recruitment and retention of up to 250 subjects per clinical pharmacology trial

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    Pharmacodynamic assessments required for biosimilars ranging from measurements in blood to performing glucose or insulin clamps

    View our issue of The Altascientist on the topic and contact one of our experts to learn how we can help with your biosimilar programs.

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    Supporting your Large Molecules ― from Discovery to Preclinical to Clinical Pharmacology

    Altasciences recently expanded its bioanalytical laboratory by adding space dedicated to ligand binding and cell-based assays, to continue to support and deliver quality bioanalytical solutions to our clients. The new, larger space is fully equipped to respond to the high demand of cell-based neutralization and functional assays for biologics and vaccines. We now have the additional capacity for cell lineage and functional immuno-phenotyping by flow cytometry to support both preclinical and clinical studies.

    Bioanalytical Support for Your Large Molecules

    Renowned for our vast experience in LC-MS/MS and Ligand Binding bioanalytical platforms, our team of dedicated scientists in both the U.S. and Canada provide a comprehensive suite of bioanalytical services, from discovery to preclinical to phase IV. They evaluate each request and provide customized workflows to allow accurate quantitation using the appropriate platforms (Mass Spectrometry and/or Ligand Binding).

    Why do clients appreciate working with us? Because each bioanalytical phase of your study ― method development, validation, and sample analysis ― has a Method Development Expert and/or a Bioanalytical Principal Investigator with the appropriate scientific and regulatory expertise assigned.

    Let's discuss your bioanalytical needs and how our solutions can support your preclinical and/or clinical research.

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