Clinical Trials

  • Clinical Trials
  • Small Molecule, Nonclinical Drug Development Solutions

     

    As your drug development partner, we have a deep appreciation of both the challenges and the potential of your small molecule. At Altasciences, we understand why developing your molecule requires tailored solutions at every stage. 

    Find out how our small molecule solutions help identify new and improved approaches to study designs, and anticipate development challenges as studies evolve. 

    Bring us your challenge. We have the solution.

    Challenge 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.

     

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    What Data Managers Do

    Gathering, analyzing, and presenting the data to support life-altering new medicines for people around the world is a long, complex, and detailed proces

    The Lancet Covers Altasciences’ Contribution to Research for Weight Management

     

    A Look into Weight Management Research

    Altasciences’ Medical Director and Investigator, Dr. Martin Kankam, M.D., PhD, MPH, along with a team of scientific experts, have successfully investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2•4 mg for weight management, in a randomized, controlled, Phase Ib trial.

    Access the full article co-authored by Dr. Kankam to learn about the findings, methods, and results of this trial.

    As experts in the field, we have conducted over 75 early stage trials involving antidiabetic and hypoglycemic agents in patients who are diabetic (Type 1 and 2), obese, or have metabolic syndrome or NASH. These include a large number of proof-of-concept studies investigating different measures of glucose tolerance, including clamping studies using the state-of-the-art YSI 2950D biochemistry analyzer to efficiently process multiple glucose samples per run.

    Speak with a metabolic disorder expert today.

    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.

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    Effect of Difelikefalin, a Selective Kappa Opioid Receptor Agonist, on Respiratory Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

    Seamless Transition from Clinical Study Sample Collection to Bioanalytical Analysis

     

    We are your single solution for both clinical conduct and bioanalytical analysis. Partner with our scientific experts to seamlessly make your critical go/no-go decisions… and save both time and money.

    We make the process smoother by:

    • Dedicating a team of scientific experts who are best equipped to walk you through every step of your project’s development
    • Using one integrated sample management system, Watson LIMS™, from study sample collection to bioanalytical analysis
    • Providing rapid in-house study sample shipping from our clinical site to our bioanalytical labs
    • Eliminating time loss for the reconciliation of samples
    • Ensuring timely PK analysis of safety data needed for critical, key decision making for later stage studies

    Need we say more? Start saving time, contact our experts today.

    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.

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    In a previous blog, we provided an overview of microsampling technology for preclinica

    25+ Years’ Experience Conducting Early Phase Drug Development

     

    One of the most significant milestones in drug development research is the transition from preclinical to clinical studies. Ensuring risk mitigation at all steps of preclinical and clinical testing, as well as incorporating a thorough safety review plan in the clinical setting, is integral. 

    Altasciences applies recommendations from world-wide regulatory agencies to ensure that studies are conducted safely, ethically, and in a scientifically robust manner.

    We facilitate drug development and save you time by:

    1. Preparing your preclinical study designs, including species selection and dose level determination.
    2. Conducting the required safety testing and updating your Investigational Brochure while your IND/CTA-enabling studies are in progress.
    3. Writing your IND/CTA applications.
    4. Planning your clinical program while your preclinical safety assessment is ongoing so that you can initiate your first-in-human (FIH) trials as soon as you receive regulatory approval.
    5. Designing your FIH clinical protocol using preclinical study data, including identifying the maximum safe starting doses.
    6. Timing small-scale drug formulations with clinical conduct to get your trials started sooner.
    7. Conducting your FIH trials and making quick, informed dosing decisions based on timed bioanalytical data and safety data available within 48 hours.
    8. Quickly identifying trial findings that may allow you to waive certain studies or provide critical data for safety/dosing considerations in subsequent clinical studies.  

    Our preclinical, manufacturing, bioanalytical, and clinical teams work closely together to transition drugs through the critical early phases of drug development.

    Speak with our experts.

    You may also be interested in the following:

    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.

    Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Concomitant Administration of Multiple Doses of Cagrilintide With Semaglutide 2-4 mg for Weight Management

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    Dedicated to Medical training

    He is a member of the Collège des Médecins du Québec, a Fellow of the Royal College of Physicians of Canada, certified in Internal Medicine and

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