PET Study Coordination Between Clinical & Imaging Sites
The incorporation of PET Imaging Studies within clinical trials requires efficient coordination between the Clinical Research Organization (CRO) executing the clinical trial and the PET center responsible for the PET imaging study.
Participant Recruitment & Scheduling
Participant recruitment is a prerequisite for successfully completing clinical trials, but recruiting a sufficient number of study subjects can be challenging and lead to study delays.
BioPharma Services has an experienced team of recruitment and screening specialists who oversee the timely recruitment of study participants. Our recruitment specialists rely on BioPharma’s extensive database of potential study participants, including more than 18,000 normal healthy volunteers (NHVs) and individuals from special populations.
Staff Delegation
Clinical trials, including PET scans, are commonly conducted at two different sites, meaning that staff delegation at both sites should be regulated. BioPharma Services shares the responsibility for staff delegation with our academic partners. The Principal Investigators (PI) for PET imaging studies are designated by our academic partners, while we designate sub-PIs responsible for the clinical portions of the studies.
BioPharma Services’ sub-PI has delegation capacity for BioPharma’s staff, whereas our academic partner’s PI is responsible for delegation of the academic imaging staff.
Source Document
Management
The collection and maintenance of accurate, complete, and accessible source documents is of paramount importance. Source document management can be especially challenging when conducting clinical trials with PET imaging studies due to the frequent involvement of two separate sites — a clinical site and an imaging site.
BioPharma’s data managers have established procedures for efficient document management, ensuring that all source documentation for PET imaging studies is handled appropriately.
Regulatory Guidance
Considering all regulatory aspects of clinical trials involving PET imaging early during the trial design process is essential for their successful conduct and completion. BioPharma Services’ proficient regulatory specialists ascertain that all study aspects comply with the requirements of regulatory agencies.
Our regulatory team has successfully undergone over 30 regulatory inspections by various agencies, including the United States FDA, Health Canada, United Kingdom MHRA, Danish Medicines Agency, French ANSM, Brazilian ANVISA, and the World Health Organization.
State-Of-The-Art Clinical Facility to House Study Participants
PET imaging is generally carried out at academic centers; however, they usually cannot accommodate the study participants as required for early-phase clinical trials.
BioPharma Services has established a state-of-the-art Phase 1 center in Toronto, Canada, that can house all participants in our early-phase clinical trials. Both centers have comprehensive safety monitoring capabilities with dedicated Phase 1 intensive monitoring units, 24-hour monitoring, a nursing station in the rooms, and a telemetric option. The clinical teams working at our Phase 1 clinical trial center include experienced PIs, ER physicians, anesthesiologists, and Advanced Cardiac Life Support (ALCS) trained staff.
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