Clinical Research Engineers are the feet on the ground and the ambassadors of your company.
We have a profound appreciation for the core competencies required for a successful patient recruitment site which includes a matrix of several performance factors.
Our understanding of the finer details will enable success with the clinical trial site selection process to facilitate meeting your critical milestones for patient enrolments.
Whether your trial is a First in man, safety or efficacy trial Phase1-IV, Clinical Research Engineers can provide site selection.
Our Site selection process is an analysis of :
- Investigator/PI profile
- Hospital/Site profile
- Hospital/Site procedural habits
- Track record of recruitment in previous trials
- Interdisciplinary relationships
- Clinical Research teams capabilities
- Matching inclusion criteria to large patient cohorts
- Implementing a risk mitigation strategy to ensure adequate recruitment
Success is in the detail and in the analysis of specifics for successful protocol implementation ( As an example, evaluation of site compatibility for the imaging protocol or evaluation of specialized sterilization requirements for equipment)
The sites compatibility with a study requires some ‘’insider” knowledge of the site. This is our forte in site selection.
Once there has been the appropriate site selection identification and qualification, Clinical Research Engineers can help with appropriate and effective tools to facilitate:
- Contracting and budgeting
- Clinical Trial Agreements (CTAs)
- Essential documents
- Ethics Committee approval & Governance,
- Site Initiation Visit and all activities through to Site Activation.
- Patient recruitment planning activities