Contract Research Organization (CRO) Scientific IT Services & Informatics Consulting

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


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.
Reporting through pre-defined formats like MedWatch, CIOMS, and sponsor validated specific formats, EDC on-prem automation solutions
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.
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...
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...
SEND and CDISC data standards for NDA, ANDA, and BLA submission support.
Objectives/endpoints definition, schedule of events, sample size optimisation, statistical analyses, operationally feasibility, medical writing, regulatory submissions