Clinical Data Management

Our Clinical Data Management team has solid experience in Phase I to Phase IV clinical data management services. We are committed to providing the highest data quality, integrity, and security for our clients in meeting 21 CFR part 11, GAMP 5 and HIPAA requirements. Using industry-leading electronic data capture (EDC) technologies. We provides end-to-end clinical data management support from eCRF design to database lock and final study archival.

Our processes are compliant with CDISC standards, CDASH, Controlled Terminology, SDTM, ADaM, Define-XML, and Study/Trial Design Model standards.

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