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Clinical Data Management Services
FromHingeClinica
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.
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clinical phase
Study initiation 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
Study conduct phase
- Data cleaning
- Query management
- Query aging
- Ongoing QC
- Medical Coding
- Post production changes (PPC)
- SAE reconciliation
- Data listing transfer & review
- DM metrics & status reports
Study closeout phase
- 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