Conducting clinical trials is inherently complex, and engaging with sites is becoming even more competitive given limited capacity and increasingly overburdened site staff. In this environment, local knowledge and global experience in site feasibility studies is essential. IRN’s dedicated local teams can provide you with an in-depth understanding of the current dynamics in your area of study and the regions you are considering for your trial.
We work closely with you to identify the optimal strategy for your study. Our global feasibility team, in close collaboration with local Site Coordinators and PIs, provide insight on key country-specific clinical considerations to support critical decision-making in your development program. These include, for example, top-level feasibility and site-level feasibility gained from detailed feedback from our clinical research sites. We will help determine important parameters such as:
Relative recruitment potential
Most favorable countries
Local standard of care, including availability and national reimbursement
Viable patient assessments
Potential study and/or recruitment challenges
Competitive trial landscape
Protocol review and investigator grants
However, basing operational strategy on site-level feasibility alone is insufficient. Utilizing our internal intelligence base combined with proprietary data sets, we evaluate the epidemiological and competitive trial landscapes, and assess the impact of country-level approval and reimbursement of standard-of-care therapies currently on the market. This comprehensive analysis is ultimately compiled into a detailed report that provides you a realistic and comprehensive outlook on the landscape for your trial, with key recommendations to guide your study planning.
With collaboration from our medical and operations teams, we review your study design and protocol and can give you guidance about feasibility in any stage of the trial. Depending on your needs, we offer a complementary, blinded feasibility study conducted during the early pre-award phase, in addition to in-depth analysis and data to support continued joint discussions and preparations for your project.
Pre-study feasibility evaluations can be especially beneficial, particularly if you will be conducting a rare disease trial. We’ll develop customized questionnaires to derive the relevant information. Post-award, our experts can provide support with GDPR, navigating the privacy notices for investigators and staff. We will tailor our work based on your needs, budget, and the complexity of your study.