MAJARO InfoSystems
Provider of clinical data management software and contract services focused on SAS-based clinical trials workflows. Offers clinical data entry and management, statistical analysis, regulatory e-submissions support, medical writing, and SAS programming/data integration. Operates a CRO services division and sells/implements SAS analytics and BI software. Headquarters in Santa Clara, CA.
Industries
Nr. of Employees
small (1-50)
MAJARO InfoSystems
Santa Clara, California, United States, North America
Products
SAS-based clinical data management system
Integrated clinical data management system built on SAS for study definition, multiple data-entry modes (including double-key entry), CRF imaging, forms control, query capture and resolution, dictionary coding, clinical data review tools, and preparation of data for FDA electronic submissions.
SAS-based clinical data management system
Integrated clinical data management system built on SAS for study definition, multiple data-entry modes (including double-key entry), CRF imaging, forms control, query capture and resolution, dictionary coding, clinical data review tools, and preparation of data for FDA electronic submissions.
Services
Contract data entry and management services including double-key entry, edit checking, query management, CRF imaging, data validation and QA, and remote data entry.
Protocol development, study design, FDA strategic planning and CRF design/printing.
Statistical planning and analysis across Phases I–IV, NDA/BLA/IND preparation, annual and statistical report generation, and consulting.
Preparation of IND reports, investigator brochures, protocols, clinical study reports, manuscripts, integrated summaries, common technical documents, and document QA audits.
SAS programming for FDA-ready datasets, custom application/GUI development, data integration and migration, and SAS training courses.
Preparation and packaging of data and CRF images to meet FDA e-submission standards.
Contract data entry and management services including double-key entry, edit checking, query management, CRF imaging, data validation and QA, and remote data entry.
Protocol development, study design, FDA strategic planning and CRF design/printing.
Statistical planning and analysis across Phases I–IV, NDA/BLA/IND preparation, annual and statistical report generation, and consulting.
Preparation of IND reports, investigator brochures, protocols, clinical study reports, manuscripts, integrated summaries, common technical documents, and document QA audits.
SAS programming for FDA-ready datasets, custom application/GUI development, data integration and migration, and SAS training courses.
Preparation and packaging of data and CRF images to meet FDA e-submission standards.
Expertise Areas
- Clinical trial data management
- Electronic data capture (EDC)
- Statistical analysis and reporting
- Regulatory submission support and e-submissions
Key Technologies
- SAS-based analytics and dataset workflows
- Electronic Data Capture (EDC)
- CRF image capture and processing
- Audit trails and 21 CFR Part 11 controls
News & Updates
Planned exhibition at PharmaSUG 2010 in Orlando, FL.
Planned exhibition at the DIA 46th Annual Meeting in Washington, DC.
Planned exhibition at the 2010 SCDM Fall Conference in Minneapolis, MN.
Third-party articles and conference papers discussing SAS-centric clinical data management approaches and tools.
Planned exhibition at PharmaSUG 2010 in Orlando, FL.
Planned exhibition at the DIA 46th Annual Meeting in Washington, DC.
Planned exhibition at the 2010 SCDM Fall Conference in Minneapolis, MN.
Third-party articles and conference papers discussing SAS-centric clinical data management approaches and tools.