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

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hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” 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How Celegence Leverages CAPTIS^® to conduct Efficient Benefit-Risk Analysis for Medical Devices

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]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.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” awb-switch-editor-focus=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Why Choose Celegence for Your Benefit-Risk Analysis?

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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.

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How Celegence Uses CAPTIS® to Achieve Efficiency

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1. • 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.

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Why Work With Celegence?

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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.

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

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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!

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