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The Minnesota Diet Research Center

Case Study 2: Safety Reporting for Dietary Supplement


Situation Large, global company required post-market surveillance of all safety reports for their new dietary supplement food product (first in class; new brand).
Task Developed system to track all adverse events (AE) and communicate results.
Actions Taken Developed specialized call center to log, categorize, track and report all AE calls using downloadable access.
Results Provided monthly reports and multi-year comprehensive safety overviews (developed individual categories and statistical trends analyses).
Benefit 1 Safety oversight expertise added to corporate team: Alimentix provided subject matter expertise (company lacked knowledge/experience receiving/tracking safety reports, designing, developing and running call center to collect AE reports from callers, and this work required specialized, clinical safety expertise in immunology, nutritional counseling, dietary safety and laboratory medicine).
Benefit 2 Increased productivity of corporate team: Monthly report always completed on time and not as an “add on” responsibility for company staff.
Benefit 3 Novel scientific observations recorded in real time: Company notified of significant trends in real time and facilitated development of new clinical trial ideas to support safety initiatives.
Benefit 4 Regulatory reporting facilitated: Company received comprehensive and detailed monthly summary and updated overview/annual reports for submission to the FDA or others to meet new safety reporting requirements.