To the Rescue: A New Hope for Your Development Program

Did You Know? Site Performance is notably inconsistent for studies that needed assistance.

Common communications barriers between Sponsor and CRO that lead to rescue scenarios. Have a study that’s struggling? Our team offers complimentary study reviews.


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Site Performance is notably inconsistent for studies that needed assistance…
 

rescue-high-performing-sites.pngHigh Performers(i.e., enroll 70% of evaluable patients)rescue-high-better-than-average-sites-1.webpAverage Performers(i.e., enroll 25% of evaluable patients)rescue-average-sites.pngUnder Performers(i.e., enroll 5% of evaluable patients)rescue-poor-performing-sites.pngNever Enroll
a Single Patient

Rescue Study (n.)

1 Allucent’s process of course-correcting a clinical trial to meet its enrollment, research, and quality objectives, or to better match its SOPs.

 

 

 

Rescue Studies take many forms, happen for many reasons, and range from supplemental services to complete trial takeovers.

Top 7 Reasons Sponsors Choose Allucent for Rescue Studies

rescue-enrollment-behind.pngBehind on Enrollmentrescue-financial-issues.webpFinancial Issuesrescue-poor-study-management.webpPoor Study Management rescue-quality-issues2.webpQuality Issues

 
rescue-delays2.webpDelayed Timelinesrescue-regulatory-shortcomings2.webpRegulatory Shortcomings rescue-lack-of-resources2.webpLack of Resources

 

Survey: What Issues Are Plaguing Your Development Program?
 

rescue-poll-quality-issues.webp20%
Quality
Issues
rescue-poll-poor-recruitment.webp50%
Poor Recruitment
rescue-poll-budget.webp20%
Going Over
Budget
  rescue-poll-poor-management.webp10%
Poor Study
Management



 

Study Transfer is often associated with…

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Why are Rescue Studies Important?

Rescue Studies harmonize each of the critical factors to a study’s success.
 

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Rescue Studies Also Resolve What Tends to be the Largest Issue: Communication!

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The Key to Study Success is to
COMMUNICATE Throughout Transfer.


Common communications barriers between Sponsor and CRO that lead
to Allucent Rescue scenarios

  • Incomplete understanding of the project status
  • Lack of a detailed handover plan
  • Poor implementation or lack of follow-through of communication plan
  • No consensus on project timelines or supporting tracking plans
  • Inconsistent documentation of tasks, priority lists and contracts
  • Misalignment with study budgets
  • Study team is not clearly identified, and/or responsibilities are not clearly delegated

Key tips to remember from the Sponsor and CRO perspective:

ROLES & RESPONSIBILITIES:
How Sponsors & Allucent Cooperate to Ensure a Successful Development Program Rescue

Sponsor

   Assume project oversight from incumbent CRO

   Prepare project for handover

   Support communications among key touchpoints during handover stage

   Ensure cooperation from incumbent CRO

CRO

   Identify reasons for study failure, identify solutions and recommend adaptations

  Create a documented rescue process

  Deploy a therapeutically and functionally experienced, dedicated and flexible team

   Ensure effective communication with Sponsor and incumbent CRO

   Deploy recruitment strategy with motivated sites

 

 

 

 

 

 

 

 

 

Have a study that’s struggling?
Our team offers complimentary study reviews.

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