EDC Archives - Medigen Suite

EDC

Electronic Data Capture (EDC) is the backbone of modern clinical data management. This collection covers eCRF design, data validation, medical coding, CDISC standards, and how a connected EDC supports cleaner data and faster database lock. Explore practical guidance for sponsors, CROs, and data managers running drug and device trials

eClinical Software: The Case for a Unified Platform

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eClinical Software: The Case for a Unified Platform

eClinical Software: The Case for a Unified Platform

e.trombettoni2026-06-12T15:25:10+01:00

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 >".

MedDRA Coding: How Auto-Coding Saves Hours per Study

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MedDRA Coding: How Auto-Coding Saves Hours per Study

MedDRA Coding: How Auto-Coding Saves Hours per Study

e.trombettoni2026-06-12T15:21:01+01:00

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

CDISC Standards Explained: SDTM, ADaM, CDASH

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CDISC Standards Explained: SDTM, ADaM, CDASH

CDISC Standards Explained: SDTM, ADaM, CDASH

e.trombettoni2026-06-12T15:16:45+01:00

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

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

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

e.trombettoni2026-06-12T15:15:00+01:00