Services

Data Management

From database design through final data lock — delivering clean, audit-ready clinical data.

Clean, well-structured data is the foundation of every credible clinical trial. Our data management team handles the full lifecycle — from database design through final data lock — ensuring your study data is accurate, complete, and audit-ready.

Core Capabilities

EDC System Setup and Configuration

We design and build electronic data capture (EDC) databases tailored to your study protocol, including edit check programming, data validation rules, and user acceptance testing.

CRF Design

Our case report form (CRF) designs balance clinical needs with data management efficiency, capturing the right data in the right format from the start.

Data Cleaning and Reconciliation

We run systematic data reviews, generate and resolve queries, and reconcile data across sources (EDC, central lab, ePRO, imaging) to deliver a clean, locked dataset ready for analysis.

Medical Coding

We code adverse events, medical history, and concomitant medications using MedDRA and WHODrug dictionaries, applying consistent coding conventions across your program.

Database Lock and Archival

Our team manages the database lock process with full audit trail documentation, and prepares archived datasets for long-term regulatory retention.

Full Service Scope

EDC system design and configuration
CRF development and review
Data management plan (DMP) development
Edit check programming and validation
User acceptance testing (UAT)
Data query management
Central lab data reconciliation
ePRO and imaging data reconciliation
MedDRA adverse event coding
WHODrug medication coding
Database lock coordination
Data archival and regulatory retention