START operates under the leadership of highly trained physicians and staff with extensive experience in Phase I clinical trials research and are nationally recognized as leaders in cancer research and drug development.
Investigational Drug Section
The Investigational Drug Section (IDS) occupies approximately 1,500 square feet which includes secure drug storage areas with limited access and an ISO Class 7 clean room with three Class II Type A2 biological safety cabinets for sterile compounding. All drug storage areas are electronically temperature monitored 24/7. In addition to controlled room temperature storage, the IDS has laboratory grade refrigerators, freezers and an ultra-low freezer to accommodate cold storage of investigational agents.
IDS staff includes three full-time clinical pharmacists and three full-time certified pharmacy technicians. With a combined 30+ years of experience in oncology clinical trials, the IDS staff is happy to assist pharmaceutical companies in the development process of new agents.
The IDS pharmacists provide extensive screenings of home medications and supplements for all patients enrolling in Phase I studies. Prohibited medications, medications with potential drug-drug interactions, and agents which may interfere with the assessment of toxicities or interfere with laboratory tests are identified. In addition, pharmacists also assist physicians in providing supportive care to patients.
Phase I Clinic
At START, we provide quality data through timely enrollment of study participants. The Phase I research staff is comprised of a variety of specialized team members including Registered Nurses, Licensed Vocational Nurses, Front Desk Schedulers, Research Nurses, Study Coordinators, Clinical Research Assistants, and Medical Records Technicians all dedicated entirely to the Phase I program. Staff members are trained in Good Clinical Practices (GCP) and are also highly experienced in the field of oncology.
The exam area at START includes 10 exam rooms for our clinical trial participants.
The START clinic has a research dedicated treatment room for clinical trial patients. This area includes 21 treatment chairs and 3 bed/gurney areas.
The START clinic has uninterrupted digital cardiac monitoring capabilities in early and late development clinical studies. At START we utilize a wireless Holter monitoring system for cardiac and QTc evaluations.
The PK Department processes and ships all samples for the clinical trials conducted at START. The laboratory has up to date equipment to include four swing bucket centrifuges that have room temperature capabilities as well as cold temperature capabilities. Yearly maintenance and calibrations are conducted on the equipment in order to maintain accurate speeds and temperatures. The lab is also equipped with -80°C and -20°C freezers and refrigerators that electronically temperature monitored 24/7.
Regulatory Affairs Department
The mission of START’s Regulatory Affairs Department is to gain necessary approval from the Institutional Review Board (IRB) to enroll patients appropriately in investigational studies at START. The department ensures compliance with all regulatory and industry requirements, following FDA guidelines and good clinical practices for every study. Regulatory Affairs also maintains the database of all pertinent information about and for each study. Regulatory issues are centrally important to clinical trials and essential for ensuring the safety of every patient enrolled in a study, and there are numerous details and obligations, all of which our team handles with experience and dedication to excellence.