Feasibility

Feasibility

Accord Research initiates every clinical trial by conducting a detailed feasibility process to identify strategic countries and key sites. We consider the selection of countries and investigational sites as a critical step in the clinical trial that determines the future success of the project.

Accord Research has an extensive database of clinical sites and investigators in numerous therapeutic indications across Europe, and maintains personal relationships with the key opinion leaders.

During the feasibility process we take into account a range of key factors which play an important role in the country and site selection.
These key factors include the standard of care principles, availability of patients (both current and retrospective), competing trials, regulatory requirements and timelines, availability of equipment based on protocol requirements, the overall site and investigator’s prior experience, and the ability to meet and fulfil the protocol and Sponsor requirements. 

The process of feasibility starts with an in-depth protocol analysis, including all inclusion and exclusion criteria, patient population and treatment. Based on this we prepare a bespoke feasibility questionnaire. 

We then contact  key opinion leaders in the given therapeutic area, alongside other potential investigators. Once they have expressed initial interest and signed a confidentiality agreement, we provide them with the questionnaire and obtain the required information.  We also ascertain their interest in the study and take feedback on the protocol. Once all of the relevant data is satisfactorily collated either by phone, email or a personal visit, the results are fed back to the Sponsor along with a comprehensive list of proposed sites and an accompanying narrative of why each site has been selected.

The feasibility process is always managed by an experienced PM or PD to ensure the quality and the reliability of information.