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Clinical Pharmacology Modeling SimulationTo the Rescue: A New Hope for Your Development Program
October 28, 2019
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.
Site Performance is notably inconsistent for studies that needed assistance...
|
High Performers(i.e., enroll 70% of evaluable patients) |
Average Performers(i.e., enroll 25% of evaluable patients) |
Under Performers(i.e., enroll 5% of evaluable patients) |
Never Enroll
|
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
|
Behind on Enrollment |
Financial Issues |
Poor Study Management |
Quality Issues |
|
Delayed Timelines |
Regulatory Shortcomings |
Lack of Resources |
Survey: What Issues Are Plaguing Your Development Program?
|
20% |
50% |
20% |
10% |
Study Transfer is often associated with...
Why are Rescue Studies Important?
Rescue Studies harmonize each of the critical factors to a study’s success.
Rescue Studies Also Resolve What Tends to be the Largest Issue: Communication!
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.