It’s now time to start implementing the research program at your practice! We will evaluate the patient population of your practice to determine what type of clinical trials will provide the most benefit to your patients and practice. During this time, we will set up the research office within the practice and begin hiring clinical research staff. While this is taking place, the PI and any other research staff members of your practice will begin completing the required trainings that are imperative for any new staff to complete for clinical trial submissions to begin.
Once trainings are completed, we will begin applying for trials that are relevant based on your patient population. When applying for a clinical trial, the application process is time sensitive and will require a less than 72-hour response time from the research staff. After an application and/or feasibility questionnaire has been accepted, we will prepare for a Pre-Site Visit with the sponsor to ensure that the site meets all the requirements to conduct the clinical trial. Once the Pre-Site Visit is completed, a Site-Initiation Visit (SIV) will be scheduled with all research staff, the PI, and sponsor to provide training on the protocol to all staff. Once the SIV is completed and all staff is trained and delegated, the site will begin enrolling patients into the study.