Fact SheetAutomating CER Literature Reviews
Be Audit Ready and Compliant
Even with the deadline for the European Union’s Medical Device Regulation (MDR) extended to May 26, 2021, organizations are still establishing business and operating standards for their clinical Evaluation Reports (CERs).
In fact, according to KPMG and the Regulatory Affairs Professionals Society (RAPS), 66% of medical device manufacturers do not “have a strategy in place to sustain compliance to MDR requirements.”
If this added scrutiny was not enough pressure, medical device manufacturers also have limited time and resources. In many cases, the number of required CERs exceed the available resources to produce them. Many teams work with a variety of professionals with diverse expertise levels, directly impacting the efficiency and accuracy of the CER literature review. Teams need a better way to reduce inefficiencies, keep reviews up-to-date, limit user errors, and maintain an audit-ready, repeatable, and compliant process that will meet the requirements of notified bodies.
Enter DistillerSR for CER literature reviews. Used by four of the top five medical device companies in the world, DistillerSR brings together AI and intelligent workflows that automate the management of the CER literature reviews to produce transparent, audit-ready, and compliant submissions faster and more cost effectively. Implementing a prescriptive process makes it easier to onboard new staff, move between reviews, and standardize your reports.
A standardized process also means that everything is trackable, audit-ready, and compliant. For EU MDR submissions, one of the most pressing requirements is a repeatable and transparent review process. DistillerSR utilizes project and form templates so you can complete consistent CER literature reviews across your medical device portfolio. Automatically tracked audit trails, user metrics, and article version control ensures that every change made in the project is time and user stamped, so you can trace every decision back to its source.
New EU MDR requirements present significant time, resource, cost, and management challenges for producing CER literature reviews. But with DistillerSR’s highly automated and standard approach, you produce audit ready and compliant CER literature reviews faster and with less work.
Improve Review Quality and ROI
The quality of systematic reviews is a cornerstone of trusted
evidence-based medicine. For medical device regulatory professionals, DistillerSR’s AI-enabled screening with error checking and deduplication accelerates the screening of large volumes of literature references. A recent article in BMC’s Medical Research Methodology stated that DistillerSR’s AI reduced article screening burdens by as much as five person weeks on a single project. Some DistillerSR customers have also realized AI-enabled cuts to screening loads by as much as 90%.
Powered by natural language processing, DistillerSR’s AI learns from reviewer screening behavior to automatically re-order references by likelihood of relevance or inclusion. Custom classifiers are also available to identify and tag relevant references, which further enriches reviews and helps reviewers find what they need faster.
DistillerSR’s AI enhances the quality of reviews by identifying records that may have been incorrectly excluded. Reviewers can also use an AI simulation to identify records that may have been incorrectly included – all of which optimize the totality of the literature search and the accuracy of its screening. The result? Some customers report an ROI of up to 10x driven by greater levels of automation and workflow standardization.
Reduce Administration: Improve Team Management
By automating many manual literature review tasks in DistillerSR, an individual or team of reviewers trim hours or days from their CER literature reviews. For example, you can set up alerts to automatically import new references that match search criteria, then easily find and retrieve the full-text articles.
Managing both global and local teams is simplified with DistillerSR. The platform automatically manages the assignment of literature triage to team members, ensuring the right experts are paired with literature that is within their domain of expertise. Projects can easily be partitioned by user roles and responsibilities for centralized and simplified project management. Project and form templates, meanwhile, can be cloned and used numerous times, establishing standard review protocols corporate-wide.
DistillerSR also notifies specific reviewers and teams when they have new work to complete using cross-project dashboards. CER literature reviewers can easily see and access all the work they have left to do for their projects in real time. Remote teams can collaborate easily with full transparency to reduce human error compared to traditional manual “spreadsheet” methods. User and project metrics help teams easily monitor review progress and responses in real-time, ensuring optimal quality and thoroughness.
New In Vitro Diagnostics Regulations (IVDRs) are coming in May 2022
Device manufacturers whose products fall under this category will still need to develop a repeatable, transparent process for their Performance Evaluation Report (PER) literature reviews. Approximately 80% of IVD manufacturers will shift from self-certification to Notified Body oversight under these new regulations. It will be critical for IVD manufacturers to ensure their literature reviews are streamlined, audit-ready, and compliant.
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