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SaMD validation strategy, IQ, OQ, PQ development and qualification, software validation execution and regulatory reporting across SaMD regulations
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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](https://dev.zifornd.com/wp-content/uploads/2022/01/data-integrity-compliance.jpg)
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](https://dev.zifornd.com/wp-content/uploads/2022/01/protocol-design.jpg)
Objectives/endpoints definition, schedule of events, sample size optimisation, statistical analyses, operationally feasibility, medical writing, regulatory submissions
![clinical trial monitoring services - zifo](https://dev.zifornd.com/wp-content/uploads/2022/01/cdms-set-up.jpg)
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](https://dev.zifornd.com/wp-content/uploads/2022/01/clinical-data-management.jpg)
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)](https://dev.zifornd.com/wp-content/uploads/2022/01/biometrics.jpg)
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.
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Reporting through pre-defined formats like MedWatch, CIOMS, and sponsor validated specific formats, EDC on-prem automation solutions