Feasibility – One Word meaning Two Ways of Getting it Right from the Beginning

Identifying, screening, qualifying and motivating investigational sites is an ongoing challenge for every clinical study. The more accurate the initial feasibility assessment for site identification is, the more successful the study will be. As a result the projects will be delivered on-time and completed within budget.

Is the study itself feasible? Are patients existing fulfilling all in- and exclusion criteria? Is the patient willing to run through all assessments required in this trial? Answering these questions utilizing experts in the dedicated indication and region makes recruitment predictable, controllable and and helps to ensure that it is done within time and budget.

For each project a member of the clinical operation team is appointed to oversee the feasibility for both, recruitment capacity and protocol and is supported by a dedicated team of local CRAs to manage the individual countries. With over 17 years’ experience and a broad network of Key Opinion Leaders (KOLs) and Investigators, the team has access to a large pool of sites to involve in study feasibilities across a variety of therapeutic indications and geographies.

During the Bidding Process

  • Review the clinical trial synopsis and design, carefully studying the various specific geographic regions, to assess whether the study is a good fit for a particular country or region
  • Work with clinical sites and investigators to assess the level of interest in the clinical study, as well as to identify issues that may affect recruitment, execution and/or patient retention
  • Develop a potential recruitment strategy as basis for the budget calculation and timelines, considering the geographic regions, health systems and adjusted recruitment capacity for both KOLs and investigators involved
  • Create a most realistic scenario for the bidding process with a minimal risk of significant changes

During Study Setup

  • Protocol review and adaptation of design, carefully considering the needs and differences for various specific geographic regions focused on timelines and recruitment capabilities
  • Work with clinical sites and investigators to assess the level of interest in the clinical study, as well as to identify issues that may affect recruitment, execution and/or patient retention
  • Review the competitive landscape to identify other clinical trials vying for the same or similar patient population
  • Assess feedback from the investigators with respect to capacity and competitive studies
  • Assess feedback from investigators onstudy specifics, which assists in the overall study strategy and protocol.