These are the benefits:

Accurate recruitment projections and timings

 

Site numbers are optimised and the number of poorly recruiting sites is reduced

 

Good relationships with Investigators and site staff are consolidated

 

Interest in the protocol is raised

 

Unnecessary protocol amendments are minimised

Teams can be overconfident
and don’t think it is needed, but….
No two protocols are ever exactly the same
Standard of Care may have changed
There may be new protocols competing for patients
Lack of qualified resource?
Too labour intensive to do internally
CRAs may not have deep enough understanding of the disease
CDDI has senior medical experts to drive the process and engage in peer-to-peer discussion with Investigators
Sites will be reluctant to do it?
In fact Investigators find the EbF process valuable
Sites are paid separately for this exercise
Focusses their attention on the protocol
CDA and contract take a long time to put in place
CDDI uses simplified CDAs and Letters of Agreement
Up-front investment of time, resource and budget
The process takes around 3 months if the process is planned at an early stage. And, yes, there is an up-front investment to do the work.
Big savings can be made through fewer protocol amendments, more accurate prediction of recruitment, fewer sites and reduced project management costs
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