Quick Study Startup
Our team knows the ins and outs of study startup - let us prove it to you. EXPLOREThe Study Protocol
The Study Protocol is the single most important tool for the conduction of your clinical trial – and inaccuracies and imprecision in its design may be catastrophic to the success of your study. We believe that protocol creation is a collaborative process and we work with our clients at all stages of this task to develop a solid foundation of good trial design.
The Study Protocol
The Study Protocol is the single most important tool for the conduction of your clinical trial – and inaccuracies and imprecision in its design may be catastrophic to the success of your study. We believe that protocol creation is a collaborative process and we work with our clients at all stages of this task to develop a solid foundation of good trial design.
Investigator Selection & Feasibility
This is a process that cannot be underestimated since the selection of the wrong Investigator or clinical site can immensely affect both the conduct and success of your clinical trial. With over 30-years of experience in more than 200 fully executed clinical studies, we know the optimal investigative centres with the most therapeutic expertise and a proven track record of quality and commitment. We pride ourselves on the professional relationships we’ve built with these sites and in the comprehensive feasibility reviews that we continue to perform for all research centres considered for participation.
Investigator Selection & Feasibility
This is a process that cannot be underestimated since the selection of the wrong Investigator or clinical site can immensely affect both the conduct and success of your clinical trial. With over 30-years of experience in more than 200 fully executed clinical studies, we know the optimal investigative centres with the most therapeutic expertise and a proven track record of quality and commitment. We pride ourselves on the professional relationships we’ve built with these sites and in the comprehensive feasibility reviews that we continue to perform for all research centres considered for participation.
Contract & Budget Development
We interact with the client and investigative site during the budget development process; aware of all stakeholder requirements and streamlining communication to ensure timely budget finalization. Our oversight of this process becomes an enormous time-saver for sponsors who may then continue to focus on other crucial aspects of initial study planning.
Other startup services include ICF creation, Monitoring Plan design, Trial Master File design and maintenance, site training materials, investigator meeting coordination, assistance with external vendor selection and coordination of Investigative Product/Medical Device distribution.