| 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. |
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| 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). |
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| 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. |