Fact SheetCompliant CER & PER Literature Reviews – Always Audit Ready
The new European Union Medical Device Regulatory (EU MDR and IVDR) requirements demand, among other things, dramatic increases in the frequency, documentation, and traceability of MDR CERs and their IVDR PER counterparts.
Used by 50% percent of the world’s top medical device companies, DistillerSR enables regulatory professionals and medical writers to evaluate literature for CERs and PERs faster, and more accurately in an audit-ready and compliant way.
A Single Source of Trusted Evidence
Highly manual, spreadsheet-based literature reviews lack enterprise-wide standards on how data is managed, shared, tracked, and distributed. With the increased frequency of submissions, this can result in more project work for staff, potentially leading to omitted references, bias, and user errors.
Fully Transparent, Secure, & Audit Ready
DistillerSR allows medical writer team leaders to create fully defensible, transparent, audit-ready, and reproducible reviews. The literature review software tracks all review activity and makes it easy to view the provenance of every cell of data.
You can restrict access and ensure your data meets your organization’s security standards through Single Sign-On and user permissions.
Simplified, Real-Time Oversight
Distributed teams can collaborate more effectively, with standard processes in place and reduced management overhead. Reviewers are automatically assigned and notified of new work. Furthermore, all of their incomplete work is accessible from one central location. Project managers can view real-time user and project metrics to gain insight into their team’s workload, participation, quality, and performance.
Do More Reviews Faster and Smarter
DistillerSR automates many of the traditional review tasks so you can produce work quickly, accurately, and cost-effectively.
Reviews are automatically updated with new references as soon as they become available by leveraging auto-alerts from data providers, such as EBSCO, or Ovid. Time spent re-running searches for CER and PER scheduled updates is eliminated.
Easy-To-Use, Cost-Effective Full-Text Retrieval
Freely available full-text documents can be automatically retrieved and added to literature reviews, and teams can leverage their Article Galaxy and RightFind subscriptions to order documents from within DistillerSR for the lowest possible cost.
Instant Access to Source Materials
DistillerSR is connected directly to source materials stored in your organizations’ e-Library and through DOI.org. This eliminates the tedious task of searching for and uploading full-text documents.
Artificial Intelligence (AI) Reduces Screening Times & Improves Review Quality
Using DistillerSR’s AI-powered automation and intelligent workflows enables medical writers to produce CER and PER literature reviews faster and more accurately.
Duplicate Detection & Quarantine
Using powerful duplicate detection built within your workflow, DistillerSR easily identifies and removes duplicate records. The literature review software also automatically tracks their removal for standard reporting and preserves them for future reference and retrieval.
Find Relevant References Faster
With the help of artificial intelligence (AI), DistillerSR allows you to find what you need quickly and easily sort through irrelevant materials. Its AI differentiates between relevant and irrelevant records, continuously reprioritizing the remaining, as-yet-unscreened records, and then presents them to reviewers based on the likelihood of relevance.
On average, you can find most of your relevant references between 40–60 percent sooner than conventional screening. This allows you to start working on other stages of the review more quickly.
Prevent Erroneous Exclusions
DistillerSR’s AI can also confirm that you haven’t accidentally excluded any references – it does this by double-checking your exclusions for errors, increasing your confidence in your screening decisions. Conflicts and disagreements between reviewers, meanwhile, are automatically identified and set aside for easy resolution.
Take Control of Your Reviews – The Way You Want
Manual literature review processes often rely on the varied experience of individual medical writers’ talent and industry knowledge. This can lead to ad hoc, inconsistent, and inefficient methods that can’t scale with growing submission requirements.
Create & Reuse Templates That Fit Your Protocol
DistillerSR allows you to extract, appraise, and report data in a way that fits your review protocol. Furthermore, when you need to conduct similar research, you can instantly reuse your review process across multiple reviews by creating templates. These can be copied and modified as needed for other projects.
Eliminate Time Wasted Data Cleaning
DistillerSR helps reduce human error by requiring data validation at the time of extraction, such as using pre-specifying acceptable ranges for numerical values. Configured to meet your requirements, DistillerSR’s in-form data validation lets your team spend less time and effort to acquire analysis-ready data.
Easily Meet Global Standards
You can also easily follow globally recognized standards and compliance requirements. This includes auto-generating PRISMA flow diagrams, maintaining strict version control, and producing fully transparent and audit-ready results.
Regardless of the subject matter, the size of your team, or the scope of the project, DistillerSR provides the flexibility to create a defensible, audit-ready, and fully compliant review process for your CER and PER submissions.
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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