• EDC▪19th June 2026▪6.1 min▪

    Smarter Endpoint Adjudication for Clinical Event Committees and Sponsors

    When a serious cardiac event occurs at one site and a similar event occurs at another, sponsors need to [...]

  • eLearning▪18th June 2026▪5.8 min▪

    Confident Protocol Training for High Performing Study Sites

    Clinical trials rarely fall behind because of a single major issue. More often, delays begin with inconsistent training, incomplete [...]

  • Training Management System Why Trials Need Dedicated Validated LMS
    eLearning▪18th June 2026▪6.7 min▪

    Training Management System: Why Trials Need a Dedicated Validated LMS

    Summary: As clinical trials become increasingly complex, training management can no longer be treated as a purely administrative function. [...]

  • ePRO/eCOA▪18th June 2026▪7.2 min▪

    eCOA, ePRO, or Both? How to Choose the Right Patient Data Strategy for Your Trial

    Summary: eCOA and ePRO are two of the most valuable tools available for capturing meaningful patient data in clinical [...]

  • CTMS, EDC▪18th June 2026▪8.9 min▪

    eClinical Software: The Case for a Unified Platform

    Choosing the right eClinical software has become a genuine competitive advantage in clinical research. Sponsors and CROs now have [...]

  • CTMS▪18th June 2026▪8.4 min▪

    eMVR: Electronic Monitoring Visit Reports Explained

    Too Busy to Read the Full Article? Here's What You Need to Know An eMVR is an electronic [...]

  • An infographic for Medigen Suite and Catchtrial® ELECTRONIC DATA CAPTURE promoting their AI-powered MedDRA coding software. Header and Main Value Proposition Logos: "medigen SUITE" and "catchtrial® ELECTRONIC DATA CAPTURE" are displayed side-by-side in the top-left corner. Headline: "MedDRA Coding. Smarter. Faster. Better." with "Smarter. Faster. Better." highlighted in a larger blue font. Subheadline: "AI-powered auto-coding that saves hours, improves consistency, and delivers audit-ready safety data." Visual Workflow Diagram A step-by-step visual process flows from left to right across the top half: AE Description: A text bubble reads, "Patient reported 'dull pain in chest after first dose.'" An arrow points to the next step. Auto-Coding Suggestion: A laptop screen displays the software interface, showing a suggested Preferred Term (PT) of "Chest pain (10008479)" with a Confidence Score of 95% and a green checkmark. An arrow points to the final step. Review & Confirm: A user icon with a green checkmark, indicating human verification. Key Benefits (Four Columns) Below the workflow, four key pillars are highlighted with descriptive icons: Save 40–80+ hours (Clock icon): "Reclaim time for what really matters." Improve consistency (Shield checkmark icon): "Reduce inter-coder variability with intelligent suggestions." Audit-ready by design (Clipboard checklist icon): "Complete traceability for every suggestion and override." Better data. Better decisions. (Rising bar graph icon): "Higher quality safety data for stronger outcomes." Product Features & Footer A row of four smaller icons at the bottom lists core features: Seamless integration (Puzzle piece icon) Secure & compliant (Padlock shield icon) Cloud native (Cloud checkmark icon) Built for clinical trials (People/users icon) Footer Banner: A dark blue bar spans the bottom with a star icon on the left reading, "Code smarter. Work faster. Deliver better outcomes." On the right, a bright green button reads, "Learn more at www.medigensuite.com >".
    EDC▪18th June 2026▪8 min▪

    MedDRA Coding: How Auto-Coding Saves Hours per Study

    What Is MedDRA Coding — and Why Does It Matter? MedDRA coding is the process of translating free-text [...]

  • Fastrial AI
    AI/ML▪18th June 2026▪3.2 min▪

    Fastrial AI+: ICH E6 R3-Compliant AI for Trials

    Fastrial AI+ is the AI operating layer embedded across Medigen Suite, built for compliance with ICH E6 R3 and [...]

  • An infographic promotional image for Catchtrial® Electronic Data Capture (EDC+), showcasing how the platform delivers CDISC-aligned data for clinical trials. Header and Main Visual Headline: "CDISC-Aligned Data. Approval-Ready Results." Sub-headline: "Catchtrial® EDC+ transforms clinical data, imaging, and safety into one intelligent, compliant environment to deliver approval-ready trial results." Visuals: A laptop in the center displays a "Study Data Overview" dashboard showing metrics for Data Quality, Data Completeness, Safety, SDTM Readiness, and Compliance. To the right, a businesswoman works on a laptop next to text labels highlighting: "Clinical Data," "Imaging Data," "Safety Data," and "One Compliant Environment." The 4 Core CDISC Standards in Clinical Trials The middle section breaks down four standards into color-coded columns: CDASH (Collect it Right): Standardizes eCRF design and data collection at the source. Key benefits include standardized field names, built-in edit checks, cleaner data capture, and reduced downstream mapping effort. SDTM (Structure it Right): Structures collected clinical data into standardized domains for regulatory submission to FDA, PMDA, and other global health authorities. Includes 30+ standardized domains (AE, LB, VS, DM, etc.), consistent variables, and reduced programming time/cost. ADaM (Analyze it Right): Creates analysis-ready datasets with derived variables, analysis flags, and full traceability back to SDTM source data. Mentions ADSL, ADAE, ADLB, ADTTE, and support for TLF creation. ODM (Exchange it Right): Enables standardized data exchange, metadata, and archival using CDISC ODM (XML) and Define-XML for submissions. Features seamless system interoperability and a complete audit trail. Catchtrial EDC+ CDISC-Aligned Data Journey A horizontal flowchart at the bottom illustrates the data workflow: Standardized Collection with CDASH-aligned eCRFs. Built-in Quality: Real-time validations and edit checks. Structured Data: Mapped to SDTM domains. Analysis-Ready Datasets in ADaM with full traceability. Submission & Archive via ODM & Define-XML with audit trail. Footer Call to Action: "Transform Your Clinical Data with Catchtrial® EDC+ CDISC-aligned. Submission-ready. Approval-focused." Website: www.medigensuite.com/catchtrial
    EDC▪18th June 2026▪7.1 min▪

    CDISC Standards Explained: SDTM, ADaM, CDASH

    What Are CDISC Standards? CDISC standards are a globally recognized set of data standards developed by the Clinical Data [...]

  • EDC▪18th June 2026▪7.2 min▪

    ICH E6(R3): How Your EDC Should Adapt to New GCP Rules

    The ICH E6(R3) guideline, finalized in January 2025, represents the most significant rewrite of Good Clinical Practice standards in [...]