Magnus CRO logo Magnus CRO

Medical Coding

High-fidelity MedDRA & WHO Drug coding with robust governance, reconciliation, and QC for reliable analysis and submissions.

End-to-End Coding for Clinical Trials

Magnus CRO’s medical coding service ensures clinical terms are harmonized, traceable, and analysis-ready. We combine experienced coders, validated processes, and strong governance to support reliable safety and efficacy conclusions across studies and submissions.

What We Code

  • Adverse Events (AEs) & Medical History: Coded to MedDRA with consistent PT/LLT selection and SOC alignment.
  • Concomitant & Prior Medications: Coded to WHO Drug Global with ATC classification for meaningful grouping.
  • Indications, Procedures, and Diagnoses: Standardized to support downstream analytics and narratives.
  • Device- and Vaccine-Related Terms: Mapped using sponsor conventions and domain-specific guidance.

Processes & Governance

  • Dictionary Strategy: Controlled dictionary versions (MedDRA, WHO Drug), version upgrade plans, and change logs.
  • Synonym List Management (SLM): Centralized synonym lists to standardize recurring verbatims and improve efficiency.
  • Autocoding & Manual Review: Configured autocoding with thresholds; expert manual adjudication for ambiguous/verbatim-rich entries.
  • Coding Conventions & Rules: Sponsor- and study-specific conventions (e.g., “– NOS” handling, acronyms, abbreviations, multi-ingredient drugs).
  • Deviation Handling: Documented rationale for coding overrides; audit-ready notes for inspectors.

Quality Control & Reconciliation

  • Dual Review & QC Sampling: Independent review and periodic 100% QC for critical milestones.
  • Safety Alignment: Reconciliation of AE coding with pharmacovigilance case dictionaries to ensure consistency.
  • Data Cleaning Integration: Loop-back to DM for query wording and verbatim clarifications to improve future coding accuracy.
  • Impact Assessment: Change impact summarized for affected outputs (TLFs, listings) with traceability.

Tools & Platforms

Experience with leading coding solutions and EDC-integrated modules (e.g., Rave Coder, Veeva Coder, WebCoder), along with validated in-house utilities for synonym management, audit trails, and metrics dashboards.

Deliverables

  • Audit-ready Coding Conventions and Dictionary Management Plan
  • Validated Synonym Lists and Coding Metrics (throughput, auto vs. manual rate, open queries)
  • Reconciliation Reports (AE–PV, MedDRA version alignment, WHO Drug version/ATC mapping)
  • Submission-ready traceability documentation for regulatory inspections

Need Consistent, Inspection-Ready Coding?

Talk to our senior medical coders about harmonizing your AE and medication data across studies and submissions.

Contact Us