Phase I Unit

Phase I Unit

Our site is the only site that operates and achieves quality with never before seen levels of eloquence. Each study is assigned a primary coordinator, with at least 1-6 co-coordinators to support each trial as appropriate to the trial needs. In addition, every study has an internal kick off meeting with the PI post SIV to review the primary endpoints, how to achieve patients, how to ensure safety, how to maintain protocol compliance and how to recruit and pre-screen potential patients. Prior to enrolling a subject, we have built study specific e-source documents to ensure protocol compliance and our source is reviewed/QC’d by a co-coordinator. Prior to consenting a patient on study, we complete a mock patient visit to ensure we are patient ready. When our patient is received in clinic, their first introduction to our team starts with “Hi, my name is XXX and my primary job is to ensure your rights, safety and well-being the entire time you participate in this voluntary trial if you elect to do so”. Once the subject achieves ICF, prior to proceeding with any trial related tasks our team is required to have another study coordinator QC and confirm appropriate ICF achieved and the process well documented. Lastly, our team trains more than any other research organization in the industry; we train at least 60 hours per year (2 in person trainings for the entire company, 1 monthly 2 hour meeting, and 4 meetings per month only with study coordinator and site staff) to train, develop and ensure our staff is adequate for their role on a trial. The true primary role of our staff is ingrained through training and ultimately our culture; we care about our patients and know that their rights, safety and well-being is our first priority.