Product Design
Successful study execution begins with an executable protocol. The typical approach to conducting feasibility assessment through site surveys is not predictive of actual site or overall study performance. The use of data mining tools has been a step in the right direction, but limitations on the ability to match complex eligibility criteria have restricted the value realized by these efforts.
Centerphase has created a unique, systematic, and structured evaluation of study executability. Our proprietary approach blends both qualitative and quantitative analyses to identify execution risks and calculate a feasibility score for the protocol as written. Centerphase then develops a revised score reflecting recommendations for optimizing the protocol based on a full spectrum of factors influencing study success.
Study Executability Scorecard
Feasibility Score |
Current Protocol |
With Suggested Revisions |
|
Investigator Interest and Motivation |
 |
 |
|
Scientific / Medical Feasibility |
|
|
|
Risk: Benefit, Ethical, Safety Feasibility |
|
|
|
Recruitment / Retention Feasibility |
|
|
|
Operational / Infrastructure Feasibility |
|
|
|
Operational / Technical Feasibility |
|
|
|
Financial Feasibility |
|
|
|
Total Score |
45% |
78% |
|
Confidence Level |
Moderate |
Very High |
|
|
|
Feasible
At Risk
Not Feasible