Investigational Drug Section
The Investigational Drug Section (IDS) includes secure drug storage areas with limited access and 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 full-time clinical pharmacists and 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 that 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 the timely enrollment of study participants. 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 START clinic has a dedicated treatment room that includes exam rooms and treatment chairs for clinical trial patients.
START clinics have 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 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 are 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, EMA, and GCP guidelines for every study. Regulatory Affairs also maintains the database of all pertinent information about 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.