Mount Light Services
Clinical Data Management
Clinical Data Management is not just about cleaning data —
it is about maintaining structured oversight of the data lifecycle from first
patient enrollment to database lock.Our data management process begins before the first subject
is screened. We develop a comprehensive Data Management Plan (DMP) outlining
cleaning strategies, validation logic, reconciliation plans, coding workflows,
and lock readiness criteria.
We focus heavily on risk identification during
study start-up. By reviewing CRFs and protocol requirements early, we identify
complex endpoints, safety variables, and external data dependencies that
require proactive monitoring
01
Our services typically include
Development
of Data Management Plan
Data
validation rule specification
Discrepancy
management and tracking
Query
generation, follow-up, and aging monitoring
SAE
reconciliation with safety database
External
vendor reconciliation (labs, imaging, ePRO)
Coding
reconciliation
Interim
cleaning for statistical review
Pre-lock
data review and sign-off coordination
02
We track internal performance metrics such as
Query
aging trends
Data
entry lag
Reconciliation
timelines
Clean
patient rate
This structured oversight reduces the risk of last-minute
data surprises during lock preparation.
Our India-based delivery model provides extended coverage
hours for global sponsors, allowing near-continuous query management cycles,
which can significantly reduce turnaround times.
