Challenge:
- A company specializing in wearable technology sought to update and perform remediation of CER and supporting literature
- They had previously performed an initial literature search, but the literature search design did not yield articles that supported their submission
- They were uncertain if existing consultant resource was a good fit due to the number of Notified Body submission findings
- They relied on AlvaMed’s proven track record of delivering projects on time, and within budget, along with our deep understanding of CER development and execution.
Approach:
AlvaMed implemented the following approach:
- Review of Notified Body Findings and Suggested Actions: Client requested AlvaMed’s review of their Notified Body’s Clinical Evaluation Report findings. The Clinical Affairs team reviewed the findings and suggested a revision to the Client’s Clinical Literature Search as part of their response.
- Refreshed Clinical Literature Search : AlvaMed took a second pass at literature search, honing in further by utilizing key words and sequences to narrow the scope of search and attain more focused results.
- Substantial return of files from searching multiple databases with improved keyword search: We performed a further cross check of database searches by title and author to further narrow and remove duplicates.
- Applied set of standards to Literature Search: Once narrowed down team went through an exhaustive process of researching each article, first by abstract to rule out obvious non-pertinent studies, then by full manuscript, to quantify and categorize individual articles (inclusion/exclusion of articles process).
- Appraisal: Full appraisal done of remaining articles, with documented grading system to apply uniform metrics to all articles. Those articles that rank high enough on grading scale are then further described in full table, with metrics around type of study, number of patients, relevant endpoints; outcomes achieved; safety issues and performance standards.
Results:
AlvaMed delivered the following:
- Documented response to Notified Body’s Clinical Evaluation submission findings.
- Fully documented search along with all non-relevant and relevant articles stratified and accounted for by a uniform scoring rubric.
- Ready to submit summary table fully remediated with all updated state-of-the-art relevant articles.
Impact:
Project is a heavy time burden and lift for a company, especially if they are limited with resources to dedicate to this type of remediation effort. Also, it allows a group of experts to step in, who deal with these types of searches much more frequently, so that retraining and relearning for internal staff can be obviated.
Takeaways:
- Reduced burden and risk: Saving the client valuable time and resources, by utilizing a consulting company with deep experience performing remediations.
- Enhanced compliance: Minimize the risk of non-compliance issues at future audits.
- Efficient documentation: Leveraged AlvaMed’s in-house templates and expertise to expedite documentation updates, reducing costs and delays.
- Successful CER Submission: Under a highly compressed timeline, delivered CER Submission ready document
