Clinical data management

Clinical Data Management

From Phase I to Phase IV clinical data management services, our clinical data management team has extensive experience. In order to comply with 21 CFR part 11, GAMP 5, and HIPAA regulations, we are dedicated to offering our clients the best possible data quality, integrity, and security. using electronic data capture (EDC) technology that leads the industry. We offer complete clinical data management assistance, including database locking, final study archiving, and eCRF design.
Study initiation phase
Study conduct phase
Study closeout phase
  • DMP preparation
  • CRF designing
  • CRF annotation
  • eCRF designing
  • Screen testing
  • Edit check/DVP development
  • DVP testing
  • Preparation of eCRF filling guidelines
  • UAT
  • Database Go-Live
  • Data cleaning
  • Query management
  • Query aging
  • Ongoing QC
  • Medical Coding
  • Post production changes (PPC)
  • SAE reconciliation
  • Data listing transfer & review
  • DM metrics & status reports
  • Completion of database lock activities
  • Resolve all pending queries
  • Final coding & SAE reconciliation
  • Perform blind data review checks
  • TLFs dry run
  • Investigators signatures
  • Database lock & archive