Mount Light Services
eCRF Design & EDC Development
Designing an Electronic Data Capture (EDC) database is one
of the most critical early steps in a clinical trial. The quality of database
architecture directly influences data consistency, query rates, protocol
compliance, and ultimately the time required for database lock.
Our approach to eCRF design begins with a structured and
detailed protocol review. We do not simply convert schedule of assessments into
forms. Instead, we analyze primary and secondary endpoints, eligibility criteria,
safety reporting requirements, visit windows, and downstream statistical needs.
This ensures that the database structure supports both operational execution
and final analysis requirements.
01
During the design phase, we
Map
protocol sections to structured CRF modules
Identify
high-risk data points requiring additional validation
Design
cross-form consistency checks
Align
form structures with CDISC SDTM expectations where applicable
Anticipate
integration needs for central labs, imaging vendors, ePRO systems, and
RTSM platforms
We pay particular attention to usability from a site
perspective. A poorly structured CRF increases site burden and generates
unnecessary queries. Our objective is to create intuitive, logically sequenced
forms that reduce entry errors and improve data completeness.
02
Our EDC development includes
Comprehensive
edit check specification
Logical,
range, and cross-visit validations
Dynamic
visit scheduling rules
Controlled
terminology implementation
User
access configuration
UAT coordination
and resolution tracking
Change
control documentation and version management
We maintain structured documentation throughout development,
including annotated CRFs, edit check specifications, and validation records.
This documentation becomes particularly important during audits or inspections.
Being India-based allows us to allocate experienced database
developers at a significantly optimized cost structure while maintaining
regulatory-aligned quality standards.
.jpg)
