Good site selection and initiation is the basis for a successful clinical trial.
MDU dedicated Feasibility Team, including medical, regulatory and clinical research professionals, coordinates feasibility surveys for each clinical trial. The team assesses the specific needs of each project, performs thorough risk assessment & drives contingencies planning, which results in well thought out recommendations and potential alternative scenarios.
For each project a Feasibility Coordinator is appointed supported by a dedicated team of Feasibility CRAs to manage the feasibility survey in the individual countries. Based on MDU previous experience and broad investigator network of Key Opinion Leaders (KOLs) & Principal Investigators, the team has access to a large pool of sites to involve in study feasibilities across a broad range of therapeutic indications.
Potential investigators are contacted by phone to determine their interest for the study, followed by an initial feasibility questionnaire to asses overall feasibility of the study design. Feedback from the investigators on inclusion and exclusion criteria, co-medication, study procedures, patient recruitment etc., helps to define the project plan and potentially refine the protocol. It is this pro-active approach that helps to ensure the success of the projects performed at MDU.
The Feasibility Team will follow up and conduct in-depth telephone interviews or set up face-to-face meetings to discuss study specific topics in further detail and identify potential challenges that may jeopardize patient recruitment.
Our services and expertise include:
- Overall assessment of incidence of the indication in Ukraine
- Analysis of competing trials & compounds in development
- Assess country specific differences, e.g. regulatory, importation, clinical practice
- Review of trial design by therapeutic experts
- Design of the Feasibility Questionnaire
- Coordination and conduct of the feasibility survey
- Production of the data driven Feasibility report
MDU thorough approach towards feasibility in combination with MDU Patient Recruitment Services ensures selection of high performing sites and on-time patient enrollment.