Thought Leadership

To the Rescue: A New Hope for Your Development Program

Did You Know?


Study Delay

 

Rescue

 

 

Site Performance is notably inconsistent for studies that needed assistance...
 

Rescue High Performing Sites

High Performers

(i.e., enroll 70% of evaluable patients)

Rescue Average Sites

Average Performers

(i.e., enroll 25% of evaluable patients)

Rescue Average Sites

Under Performers

(i.e., enroll 5% of evaluable patients)

Rescue Poor Performing Sites

Never Enroll
a Single Patient

 

 

Rescue Study (n.)

1 Pharm-Olam International’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 Pharm-Olam for Rescue Studies

Rescue Enrollment Bheind

Behind on Enrollment

Rescue Financial Issue

Financial Issues

Rescue Poor Study Management

Poor Study Managment

Rescue Quality Issue

Quality Issues

 

Rescue Delay

Delayed Timelines

Rescue Regulatory Shortcomings

Regulatory Shortcomings

Rescue Lack Of Resources

Lack of Resources

 

 

 


 

Survey: What Issues Are Plaguing Your Development Program?
 

Rescue Poll Quality

20%
Quality
Issues

Rescue Poll Poor Reqruitment

50%
Poor Recruitment

Rescue RPoll Budget

20%
Going Over
Budget

Rescue Poll Poor Management

10%
Poor Study
Management



 

 

 


 

Study Transfer is often associated with...

Rescue Stud Transfer

 


 

Why are Rescue Studies Important?

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

Rescue Harmonize

 


 

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

Rescue Communicate Key

The Key to Study Success is to
COMMUNICATE Throughout Transfer.

 


Common communications barriers between Sponsor and CRO that lead
to Pharm-Olam 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 & Pharm-Olam Cooperate to Ensure a Successful Development Program Rescue

Sponsor

Rescue Checkbox   Assume project oversight from incumbent CRO

Rescue Checkbox   Prepare project for handover

Rescue Checkbox   Support communications among key touchpoints during handover stage

Rescue Checkbox   Ensure cooperation from incumbent CRO

CRO

Rescue Checkbox   Identify reasons for study failure, identify solutions and recommend adaptations

Rescue Checkbox  Create a documented rescue process

Rescue Checkbox  Deploy a therapeutically and functionally experienced, dedicated and flexible team

Rescue Checkbox   Ensure effective communication with Sponsor and incumbent CRO

Rescue Checkbox   Deploy recruitment strategy with motivated sites

 

 

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