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SERVICES

Amador Bioscience is committed to providing many of the various services required to achieve approval of a novel therapeutic. Our consulting strategy uses the latest technologies, industry best practices and applies strict quality control procedures. We are known for facilitating innovative development.

Since our inception in 2018, Amador Bioscience has actively supported over 100 clinical projects, including multiple IND and CTD filings in the US and China. Current clients range from cutting-edge biotech start-ups to multinational pharmaceutical companies. We perform a wide range of services in the categories below.

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Clinical Pharmacology,
DMPK & Pharmacometrics

  • Reporting services (NCA & PK/ADA/CSR)

  • Translational PK/PD

  • Population Modeling

  • Clinical Trial Simulations

  • Biostatistics & SAS Programming

  • Exposure-Response Assessment

Biostatistics & Programming

  • Clinical study design, SAP

  • Statistical assessment of clinical efficacy & safety

  • Bioequivalence assessment

  • SAS & R programming

    • SDTM and ADaM datasets

    • Tables, Listings and Figures

  • Data meets cDISC standards

  • Fully validated SAS system

    • Dataset Assembly

    • Clinical PK/PD/ADA endpoint analysis

Bioanalytical Services

  • PK/PD/ADA assay development

  • GLP/GCLP sample analysis

  • Biomarker discovery, characterization, & implementation

  • GLP and FDA 21 CFR Part 11 compliance: Fully validated computer and software systems: Implemented Quality Management System (QMS)

Clinical Development

  • Domestic & global clinical  development plan, preparation, execution & project management.

  • IND & clinical development strategy

  • Vendor selection, negotiation & monitoring

  • Regulatory, site and EC Interactions

  • Clinical study protocol design, ICF/CRF

  • Rigorous QA, QC & global HA inspection prep/training

  • Deep knowledge of IHC-GCP & local requirement

  • Relationship with Chinese medical centers and local vendors.

Precision Medicine

  • Design, monitoring & interpretation of nonclinical safety studies

  • Monitoring & reporting of clinical safety results

  • Addressing inquires from agencies, partners or investors

Medical Writing &
Regulatory Submissions

  • CSR, IND, & CTD preparation, publishing & submission

  • Regulatory meeting requests, planning, briefing packages & representation

  • Publication strategy & due diligence

  • Our team in conjunction with our document templates, SOPs, and document lifecycle management process deliver top-notch documents.

Contact us today using the webform below and one of our experts will be in touch soon to discuss your drug development needs.