Feasibility
Any project at OCT begins with a thorough feasibility analysis in order to realistically assess the possibility of conducting a trial. During the analysis, a detailed protocol and overview of the patient’s inclusion/exclusion criteria are compiled, feasibility questionnaires are prepared, the patient population is evaluated, a successful recruitment strategy is developed and implemented, the experience of researchers and sites is analyzed, and the availability of required technical support is checked.
Patient recruitment
Our approach to patient recruitment is always thorough and competent. Our main goal is to recruit patients who meet all criteria, in a timely fashion, and in line with budgets.
Research centers
Proper monitoring of research sites ensures reliable quality control. During sites visits, OCT monitors carry out all necessary procedures to verify compliance with GCP standards and local regulatory requirements by:
- Conducting staff training regarding the verification of Informed Consent Forms signed by patients.
- Reviewing and verifying all source documentation.
- Checking obtained research data for reliability, completeness and consistency in adherence to the Protocol.
In addition, the company is thorough when it comes to the selection of research sites, so as to to avoid the inclusion of subjects that do not meet the requirements of the Protocol.
