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.
| Client | Indication | Phase | Description | Countries | Sites | Subjects |
| Academic | College Students | Observational | 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. | USA | 1 | 400 |
| Academic | Methodology | IV | 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. | USA | 4 | 50 |
| Academic | Low Testosterone-Hypogonadal Men | IV | 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. | USA | 10 | 800 |
Contact us to discuss how our team can help you overcome study challenges.
Together, let’s make your next project a success.
