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CROS

That's good. The implementation corresponds exactly to what we had discussed. Good work. πŸ‘πŸ‘ – Medium Speciality Chemicals

OUR EXPERTISE

Our specialist expertise spans the whole spectrum of market verticals and domains where scientific processes & applications exist, and we're able to draw on a huge marketplace of partnerships with science technology providers to help determine the best way forward.
adverse
Reporting through pre-defined formats like MedWatch, CIOMS, and sponsor validated specific formats, EDC on-prem automation solutions
biometrics
CRF design, sample size determination, creating statistical analysis plans, generating tables, listings and graphs, interpreting and reporting of results in SAS, Phoenix, R, JMP and other platforms.
clinical-data-management
CDASH / SDTM / ADaM / TLG standards, therapeutic area-specific assets, SDTM and Define-XML tools, data management dashboards (remote & statistical monitoring), online data management binders for E...
cdms-set-up
Data management plan, central monitoring, data acquisition, ongoing data review and query management, lab data setup and management, SAE reconciliation, medical coding of terms and events, database lo...
submissions-data-curation-and-transformation
SEND and CDISC data standards for NDA, ANDA, and BLA submission support.
data-integrity-compliance
CDM meeting 21CFR Part 11, EUANNEX Part 11 and GDPR, experience with numerous data analysis/review tools and processes suggested by GCDMP