01
Database & CRF Design
CLINICAL DATA MANAGEMENT
Clinical Data Management Services
Structured clinical data management from database design and validation through conduct, cleaning, reconciliation, lock readiness and controlled transfer or archival.
LIFECYCLE
Clinical Data Lifecycle
02
Build & UAT
03
Conduct & Cleaning
04
Coding / Reconciliation
05
Lock Readiness
06
Database Lock
07
Controlled Transfer / Archive
SCOPE
Core Data Management Activities
Database & EDC Build / UAT
eCRF support, edit checks, controlled configuration, database validation and user acceptance testing where in scope.
DMP & Data Review Conventions
Study-specific roles, query conventions, reconciliation workflows, transfer rules and lock-readiness criteria.
Data Cleaning
Query management, programmed/manual review and ongoing data-quality checks through conduct.
Medical & Drug Coding
Medical and drug coding using study-specified dictionaries, where included in the contracted scope.
External Data & Reconciliation
Transfer specifications and controlled reconciliation of safety, laboratory and other vendor data as applicable.
Lock, Transfer & Archival
Lock readiness, final checks, controlled lock, and data transfer or archival according to agreed security and client requirements.
PLATFORMS
EDC & Clinical Data Platform Experience
Medidata Rave
EDC / clinical data workflows.
Oracle InForm
EDC / clinical data workflows.
Viedoc
EDC / clinical data workflows.
OpenClinica
EDC / clinical data workflows.
Ennov
Study-specific clinical data environments.
Medrio
Study-specific EDC workflows.
Greenlight Guru Clinical
Clinical data workflows, particularly in MedTech contexts where relevant.
Other Study-Specific Systems
Onboarding to client-selected systems is scoped to the assigned role and project.