Data screening & extraction tool

At Lexqara, we connect clinical documentation, PMS activities and regulatory strategy so manufacturers can build defensible clinical evidence packages. Explore the Resource Center, review our Clinical Evaluation Services, or consult MDCG 2020-6 for the clinical evidence hierarchy.

The Data Screening and Extraction Tool is an Excel spreadsheet designed to streamline literature screening and structured data extraction for clinical evidence workflows under EU MDR.

• Enable article screening against the literature search protocol with clear inclusion/exclusion outcomes

• Generate automatic counts of included, excluded, and pending results for reporting consistency

• Capture a consistent justification for each screening decision to support traceability

• Provide standardized data extraction fields to collect evidence from selected articles

• Support data stratification to prepare inputs for analysis, combination, and discussion

• Align outputs with clinical deliverables such as CER, PSUR/PMS Report, and PMCF Evaluation Report

Use this tool when you need a repeatable way to screen search results and extract article data for EU MDR clinical documents, especially when working alongside CER and literature search reports.

It covers the requirements needed for robust evidence handling. Inclusion/exclusion justification means every screening decision is documented in a consistent, reviewable way. Data stratification means extracted fields are organized to enable analysis and defendable clinical conclusions.

Within Lexqara, we help you configure extraction fields, align screening logic to your CER workflow, and strengthen clinical documentation and PMS reporting. Explore our Resource Center [https://lexqara.com/resource-center] and Clinical Evaluation support [https://lexqara.com/services/clinical-evaluation] and anchor your approach to EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj].