Adverse Event Coding
We apply MedDRA (Medical Dictionary for Regulatory Activities) to standardize adverse event terminology. Our consistent coding approach maintains hierarchical relationships between terms while enabling efficient signal detection and accurate safety reporting across your development program.
Medication Coding
Our specialists use WHO Drug Dictionary and other medication dictionaries to code concomitant medications and prior treatments. We ensure proper classification by therapeutic class, active ingredient, and anatomical therapeutic chemical (ATC) classification to support comprehensive safety analyses.
Medical History Coding
We standardize medical history terms using MedDRA, ICD-10, or other relevant dictionaries. Our approach ensures consistent classification of pre-existing conditions for accurate baseline characterization and subgroup analyses.
Coding Consistency and Quality Control
We implement rigorous quality control procedures including dual coding, automated checks, and manual reviews. Our coding decisions are guided by comprehensive coding guidelines that ensure consistency across studies and alignment with regulatory expectations.
Coding Dictionary Management
We maintain and update coding dictionaries to current versions while managing version transitions. Our team documents dictionary versions used throughout your studies to ensure transparent reporting and facilitate regulatory reviews.
Query Management
We develop targeted queries to resolve ambiguous or incomplete medical terms. Our efficient query resolution process works with sites to obtain clarification while minimizing site burden and maintaining data cleaning timelines.
Coding Reports and Metrics
We provide regular coding status reports and quality metrics throughout your studies. Our reporting includes coding completion rates, query volumes, and dictionary version updates to support study management and timeline tracking.
