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Medical Coding

We translate medical terms, such as adverse events (AEs), medical histories, indications, procedures, DME and medications into standardized codes using internationally recognized dictionaries like MedDRA (Medical Dictionary for Regulatory Activities), WHO Drug Dictionary, ICD-9, ICD-10, CPT, HCPCS. Accurate coding ensures regulatory compliance, supports signal detection, and enhances data analysis.

Adverse Event & Medical History Coding

MedDRA Coding

  • Coding of:

    • Adverse Events (AEs) / Serious Adverse Events (SAEs).

    • Medical Histories.

    • Indications for Use.

    • Procedures and Investigations.

  • Use of Lowest Level Term (LLT) linked to a Preferred Term (PT) and appropriate System Organ Class (SOC).

  • Alignment with the latest MedDRA version updates and version tracking for audit readiness.

  • Application of coding conventions for consistency across cases and studies.

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Custom Coding Conventions

  • Sponsor-specific or project-specific coding guidelines and rules.

  • Development of coding deviation logs for non-standard terms and their rationale.

Coding Dictionary Management

  • Version Control: Implementation and tracking of MedDRA/WHO-DD version changes per regulatory timelines.

  • Upgrade Impact Analysis: Assessment of impact on coded data during dictionary version upgrades.

  • Dictionary Maintenance: Loading and validating new dictionary versions in the safety or clinical database.

Concomitant Medication and Substance Coding

WHO Drug Dictionary (WHO-DD) Coding

  • Coding of:

    • Concomitant Medications.

    • Suspect and Concomitant Drugs.

    • Vaccines and Biologics.

  • Mapping to:

    • Drug Name + ATC Code.

    • Preferred Base/Record Number.

    • Drug Groups or Drug Classes for signal detection and interaction analysis.

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Dosage and Route Standardization

  • Mapping of dosage forms, frequency, and routes of administration using controlled dictionaries (e.g., CDISC CDASH).

Compliance and Regulatory Alignment

  • Ensures adherence to:

    • ICH E2B guidelines for electronic reporting.

    • MedDRA Term Selection: Points to Consider (PtC).

    • Good Pharmacovigilance Practice (GVP) Module VI requirements.

  • Supports signal detection and aggregate reporting through accurate PT/SOC mapping.

  • Inspection-ready coding logs and version history.

Quality Control and Reconciliation

QC/QA Review

  • Double-coding and peer review for high-volume or critical studies.

  • Verification of accuracy, clinical relevance, and regulatory consistency.

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Coding Reconciliation

  • Cross-checking coded terms between clinical and safety databases (e.g., EDC vs. Argus).

  • Resolution of discrepancies between coded data and verbatim terms.

Clinical Coding for Optimized Reimbursement

  • Learn more in Revenue Cycle Management section

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