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Optimizing start up activities to decrease your study timeline - Part 2

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This presentation is part 2 in a 3 part series of presentations on optimizing the clinical start up activities.

Published in: Healthcare
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Optimizing start up activities to decrease your study timeline - Part 2

  1. 1. Optimizing Start-up Activities to Decrease Your Study Timeline Part 2: Agreements and Ethics Review
  2. 2. Areas of Focus • Part 2 - Agreements and Ethics Review
  3. 3. Agreements and Ethics Review • Execute a Master Service Agreement (MSA) • Build a transparent budget • Early approval goes a long way…
  4. 4. MSA • Applicable if you plan to use a site more than 1 time (consider across devices and therapeutic applications) • Can reduce delays in common areas including: – Indemnification – Insurance requirements – Intellectual property – Payment terms
  5. 5. Budget • How to reduce budget delays: – Develop template budget • Account for items outside the standard of care – Determine a standard percentage you are willing to provide for overhead – Transparency: include in your template with assumptions
  6. 6. Budget transparency • Make clear assumptions on: – Site staff supporting the trial including competitive research bill rates – Clearly note what items will be unit-based costs and what will be flat fee costs – Provide budget buffer to ensure the site can complete the tasks as required • Include patient time, data collection, data transcription, regulatory requirements, etc.
  7. 7. Leveraging a Central Ethics Review • Consider identifying a central IRB site to: – Early review / approval of approved study – Leverage for additional review deferrals – Build credibility with other sites considering participation
  8. 8. Optimizing Start-up Activities to Decrease Your Study Timeline For more information or to schedule a discussion, contact us at: info@emergentclinical.com

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