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How Regulatory and Clinical Teams Can Work Better Together During Trials

  • 72 minutes
  • 38 slides
What we'll cover
  • 0:00 Where Friction Actually Starts
  • 8:00 Two Functions, Different Clocks
  • 18:00 Critical Trial Handoff Points
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What you'll take away

Practical shifts you can apply this week

  • Identify Recurring Breakdowns

    Spot where assumptions on evidence, timing, and ownership create delays across the trial lifecycle.

  • Compare Functional Priorities

    See how clinical and regulatory teams weigh risk and timing differently in key trial moments.

  • Diagnose Handoff Risks

    Catch weak points early in protocols, amendments, safety updates, and country submissions.

  • Design Governance Rhythm

    Set a practical cadence for cleaner decisions without adding another meeting that could have been an email.

  • Draft Collaboration Plan

    Leave with roles, triggers, and escalation rules you can apply to one live study right away.

Agenda

What we'll cover

  1. 0:00

    Where Friction Actually Starts

    Why conflict usually begins upstream in mismatched assumptions, not effort or personalities.

  2. 8:00

    Two Functions, Different Clocks

    Compare clinical momentum with regulatory defensibility and how both shape tradeoffs.

  3. 18:00

    Critical Trial Handoff Points

    Walk through protocol, amendment, country activation, safety, and inspection readiness handoffs.

  4. 29:00

    Failure Patterns In The Wild

    Review recurring breakdowns using examples from oncology, EU launches, safety updates, and mock inspections.

  5. 39:00

    A Better Operating Model

    Build lightweight governance with clear decision rights, trigger events, and minimum documentation.

  6. 48:00

    Tools That Make It Stick

    Use handoff maps, decision logs, and escalation paths to reduce ambiguity fast.

  7. 55:00

    Apply It And Close

    Map the next three handoffs for one live study, then recap and move into Q&A.

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