How Celegence Leverages CAPTIS to conduct Efficient Benefit-Risk Analysis for Medical Devices

How Celegence Leverages CAPTIS® to conduct Efficient Benefit-Risk Analysis for Medical Devices

In the fast-paced world of medical device regulatory affairs, conducting a thorough benefit-risk analysis is a time-consuming yet critical task. At Celegence, we understand these challenges firsthand. That’s why we utilize CAPTIS® our powerful AI-driven platform that streamlines literature reviews, automates adverse event data retrieval, and simplifies report writing. By leveraging cutting-edge technology, our medical writers deliver faster, more accurate, and regulatory-compliant reports, giving our clients a distinct advantage.

Why Choose Celegence for Your Benefit-Risk Analysis?

Medical writers often struggle with:

  1. Scattered Data Sources: Managing literature references, risk assessments, and extracted data across multiple systems is inefficient.
  2. Manual Data Extraction: Identifying risks and adverse events from literature takes time and is prone to human error.
  3. Cumbersome Adverse Event Searches: Searching the FDA’s MAUDE database is a manual, fragmented process.
  4. Time-Intensive Report Writing: Ensuring consistency across risk data, literature findings, and device descriptions requires significant effort.

At Celegence, we overcome these challenges using CAPTIS®, allowing us to deliver benefit-risk analysis reports with unmatched speed and precision.

How Celegence Uses CAPTIS® to Achieve Efficiency

    • Ensure Full Traceability: No more scattered information—every literature reference and review decision is stored in one place.
    • Identify & Tag Risks Seamlessly: Our writers tag risks and adverse events directly from literature sources, aligning them with risk files.
    • Leverage AI for Data Extraction: AI-powered prompts streamline data identification, allowing us to extract key risk-related information effortlessly.Literature Review Data – A Single Source of Truth: CAPTIS® centralizes all literature references, review decisions, PDFs, and extracted data, enabling our medical writers to:
  2. AI-Generated Summaries for Faster Analysis: CAPTIS® enhances our workflow by automatically summarizing literature findings, ensuring:
    • Consistent and Comprehensive Reporting: AI-generated summaries align with regulatory requirements.
    • Accelerated Report Drafting: Instead of manually compiling literature data, our team focuses on strategic analysis, while CAPTIS® handles the generation of literature tables and other data management tasks.
  3. Automated MAUDE & TPLC Data Retrieval: Celegence uses CAPTIS® to automate adverse event data retrieval from the FDA’s MAUDE and TPLC databases, offering:
    • Instant Access to Device Names with Reported Issues for the configured product codes.
    • Multi-Device and Manufacturer Selection for efficient searching.
    • Bypassing MAUDE’s 500-Result Constraint for full data retrieval.
    • One-Click Data Downloads for streamlined reporting.
    • Device vs Industry Totals, a functionality not available on the FDA website.
  4. Faster, More Accurate Report Writing & Review: With CAPTIS®, Celegence streamlines the entire report-writing process:
    • Integrated Source Document Linking: Product information, device descriptions, and risk data are included directly from the source files with automatic content links to the original content location.
    • Effortless Multi-Department Collaboration: Our report writing module allows seamless collaboration to include contributions from risk teams, medical affairs, R&D, PMS, and external experts.
    • Accelerated Review Process: Content links enable instant traceability, speeding up reviews and approvals.
    • AI-Powered Literature Summaries and Extractions: Our team uses AI prompts to align literature summarization with benefit-risk analysis requirements, improving accuracy and efficiency.

Why Work With Celegence?

At Celegence, we don’t just write reports—we optimize the entire drafting process using advanced AI-powered technology. Our team, equipped with CAPTIS®, ensures that your reports are comprehensive, accurate, and delivered faster than traditional methods.

Partner with Us for Best-in-Class Benefit-Risk Analysis

Ready to experience the efficiency of AI-driven benefit-risk analysis? Partner with Celegence today and let our technology-enabled medical writers streamline your regulatory documentation. Contact us at info@celegence.com for a consultation and see how we can enhance your reporting process!