Our team’s experience in Endocrinology clinical trials includes observational studies and Phase IV clinical trials.
IVR Clinical Concepts provides ePRO and IVR/IWR services for Endocrinology clinical trials and research studies.
NIH grant with voluntary participation by college students, with novel ePRO to capture behavior and attitudes during course of semester. Monetary incentive program which tracked completed diaries in real-time and reported up-to-date accounts to subjects and study personnel through our on-demand web reporting.
Two Pilot correlative Paper-Voice verification studies evaluating several validated QofL instruments, including FACIT, UCLA, PANAS, PHQ9, and SF-36, with statistical verification showing no bias when replacing paper modality with interactive voice-phone ePRO system collecting data from older hypogonadal subjects.
Low Testosterone-Hypogonadal Men
By using an IWRS system, sites registered and randomized subjects to trial product or placebo and then assigned subjects opting in to one or more sub-studies. Several of the sub-studies required subjects to complete specific Quality of Life questionnaires using IVRS phone call-in system. Subjects received reminders to engage questionnaires at various timed intervals specific to their sub-studies. Subjects’ instances of ePRO completion was electronically monitored and reported to site personnel, to help ensure continued high levels of compliance.