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The Minnesota Diet Research Center

Case Study 3: Quality System for Clinical Evaluation Process


Situation A mid-sized device company required a new process for clinical evaluation of the medical literature. Their current systems were under great scrutiny and lacked adequate/appropriate development and expertise during execution.
Task Developed methods to research, acquire, review, evaluate and report the clinical evaluation of appropriately selected medical literature in a structured, scientifically accepted manner and use this method to evaluate specific claims for company products under review.
Actions Taken Developed Standard Operating Procedures (SOPs), Work Instructions, Forms and training and completed required clinical evaluation reports.
Results Robust, comprehensive clinical evaluation processes are now being used (including detailed steps to: acquire and review appropriately selected medical literature, rate the strength/quality of the evidence and report the overall strength of the claim substantiation).
Benefit 1 Expertise added to corporate team: Alimentix provided subject matter expertise (company lacked knowledge/experience using clinical evaluation reports according to international standards to substantiate claims).
Benefit 2 Increased productivity of corporate team: Completed project within 3 weeks, not possible in-house (documented claim substantiation/level of the evidence in systematic, detailed reports with recommendations regarding the use of specific claims and wording).
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 Decreased variability and duplication of efforts during clinical evaluation of claims: Aligned literature reviews in comprehensive standardized process with formal documentation including centralized document library to be used for future clinical evaluations.