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Clinical Trials

We understand and provide IT and support services for the entire Phase 0-3 Clinical Trials process based on a long successful history of delivery. Whether you are starting at study and protocol design and ECRF set up, want to speed up EDC & site setup, biobanking and adverse event reporting or need support with biostats and regulatory submissions drafting – Zifo are experienced partners.

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 EDC/CRF setup

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 lock

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

ecrf-setup

Edit checks development, RTSM, data mapping, and migration, ePRO, SAE, pregnancy & other reports, data exports, therapeutic area-specific standards

protocol-design

Objectives/endpoints definition, schedule of events, sample size optimisation, statistical analyses, operationally feasibility, medical writing, regulatory submissions

software-as-medical-device

SaMD validation strategy, IQ, OQ, PQ development and qualification, software validation execution and regulatory reporting across SaMD regulations