Comprehensive Clinical Trial Support Services

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

zifo - software as a medical device companies

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

ecrf setup - zifo - scientific informatics

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

data integrity company - zifo - scientific informatic company

CDM meeting 21CFR Part 11, EUANNEX Part 11 and GDPR, experience with numerous data analysis/review tools and processes suggested by GCDMP

clinical trial protocol design - zifo - scientific informatics company

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

clinical trial data management companies - zifo scientific informatics company

SEND and CDISC data standards for NDA, ANDA, and BLA submission support.

clinical trial monitoring services - zifo

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

clinical data management services - zifo

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

biometrics companies - zifo rnd (scientific informatics company)

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 trial services - zifo (scientific informatics company)

Reporting through pre-defined formats like MedWatch, CIOMS, and sponsor validated specific formats, EDC on-prem automation solutions