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|