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    • BA/BE STUDIES IN HEALTHY..
    • PATIENT CENTRIC BE STUDIES
    • CLINICAL ENDPOINT STUDIES
    • CLINICAL TRIALS PHASE II TO PHASE..

    BA/BE STUDIES IN HEALTHY VOLUNTEERS

    Amaris can undertake the following Bioavailability/Bioequivalence studies

    • Single & multiple-dose studies
    • Fasting & Fed studies
    • PD studies
    • Cross over and parallel studies
    • Replicate studies
    • Proof of concept studies
    • Special population studies (postmenopausal and geriatric studies)
    • Topical transdermal patch studies
    • Inhalational studies
    • Injectable studies
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    PATIENT CENTRIC BE STUDIES

    For certain classes of drugs like cytotoxic and psychotropic drugs, BE studies can be done only on appropriate patients.

      These studies will be executed at hospital sites and centrally controlled by Mahindra City Amaris Clinical Facility
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    CLINICAL ENDPOINT STUDIES

    An endpoint is the outcome that researcher’s measure during a clinical trial in order to determine whether or not an experimental therapy is effective. Researchers select endpoints based on clinical trial design, the nature of the condition being treated, and the anticipated effect of the drug being tested. In some cases of generic drugs, the bioavailability cannot be demonstrated using conventional PK/PD studies.

      Hence a clinical end point is determined to demonstrate the equivalence to the innovator product. A clinical endpoint is an outcome that represents direct clinical benefit, such as survival, decreased pain, or the absence of disease.
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    CLINICAL TRIALS PHASE II TO PHASE IV CLINICAL TRIALS FOR IND/NCE

    No matter what stage of Clinical Trials you are, we can help you. Amaris with the help of elaborate Investigator network across various therapeutic segments, experienced and insightful Project Management Team, established mechanisms for Site Management, Clinical Data Management, Clinical Trial Management, Medical Writing, Quality Assurance service, Training and Regulatory Liaison activities can provide effective Clinical Trial services to its clients. With a strong investigator network across the globe, Amaris Clinical is forging ahead as a reliable service provider in this segment. We provide the following expert service for drug development process:

    • Selection of sites & regulatory assessment
    • Clinical Operations
    • Regulatory Affair
    • Project Management
    • Protocol Writing
    • Supervision of Protocol Deviations
    • Biostatistics
    • SAS Programming
    • Risk-Based Monitoring & Interim Monitoring
    • Pharmacovigilance
    • Medical Services
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