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

1. Optimizing Start-up Activities to Decrease
Your Study Timeline
Part 2: Agreements and Ethics Review

2. Areas of Focus
• Part 2 - Agreements and Ethics Review

3. Agreements and Ethics Review
• Execute a Master Service Agreement (MSA)
• Build a transparent budget
• Early approval goes a long way…

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. 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. 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. 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. Optimizing Start-up Activities to Decrease
Your Study Timeline
For more information or to schedule a
discussion, contact us at:
info@emergentclinical.com