Clinical & Pre-Clinical Support

    BiggsB supports drug development programs from pre-clinical work through submission and post-market obligations. We help sponsors plan and oversee studies, prepare regulatory submissions, and run clinical operations with the quality discipline regulators expect.

    Discuss Your Project

    Who this is for

    • Emerging biotech and pharmaceutical sponsors without a full internal regulatory team
    • Clinical operations teams that need experienced capacity
    • Sponsors preparing an IND, CTA, NDA or MAA

    When clients call us

    • A program is moving from pre-clinical work toward first-in-human studies
    • A submission timeline is approaching and the team needs support
    • Clinical trial oversight or documentation needs strengthening

    What the engagement covers

    • Pre-clinical study design and oversight
    • IND (Investigational New Drug) and CTA (Clinical Trial Application) preparation and submission
    • Phase I–IV clinical trial management support
    • NDA (New Drug Application) and MAA (Marketing Authorisation Application) filing support
    • Post-market surveillance support

    Deliverables

    • Development and submission plan
    • Submission-ready documentation and review comments
    • Clinical oversight plans and trial documentation support
    • Post-market surveillance process support

    How we approach it

    1. Step 1

      Plan

      Align the development and regulatory strategy with program milestones.

    2. Step 2

      Prepare

      Build the documentation and evidence the next milestone requires.

    3. Step 3

      Execute

      Support study and submission execution alongside your team and partners.

    Service boundaries. BiggsB supports sponsors; regulatory decisions and submissions remain the sponsor's responsibility.

    Questions about Clinical & Pre-Clinical

    Can BiggsB act as an extension of our clinical team?

    Yes. Practitioners can embed with your team for a defined phase of work, such as submission preparation or trial oversight.

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    Next step

    Discuss your clinical & pre-clinical project

    Tell us what you are trying to achieve. A senior practitioner will reply to discuss scope, timing and whether BiggsB is the right fit.

    Discuss Your Project