• Data management system: traditional in-house system and web based system for remote data entry which meet the requirement of FDA CFR 21 Part 11 (Electronic Records and Signatures).

• SAS macros for analysis and reporting of clinical trial data.

• Designed for pharmaceutical companies, contract research organizations (CROs), biotech's, and medical device manufacturers.

Clinical data management

• The CDM system

• Briefing
• Summary Tables (Study Population, AE Profile)
• Analysis and Reporting of Demographic data
• Analysis and Reporting of Repeat Measurement
• Analysis and Reporting of Adverse Events or Concomitant Medication
• Analysis and Reporting of Time-to-Event Data
• Analysis and Presentation of  Clinical Efficacy
• Customize Output Layout
• Online Help
• Technique Details
• Tips for Advanced Users
• Tools & Links of Statistics in Clinical Trials

Demo2008 Download

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