Statistical Analysis

CAC Croit offers statistical analysis services including creation of statistical analysis plans, analysis programs, analysis reports and chart output.

Services

We offer services across a wide range of areas. Our team continuously upgrades their skills to ensure correct analyses.

 

Our services include:

  • Operation standardization consulting
  • Creation of operation procedure, plans for statistics, analyses and charts, as well as an analysis program, analysis dataset, analysis report, unified database for CTD, and toxicity test datasets
  • Support for CSV, statistical analysis, IT strategy formulation, SAS drug development (SDD) implementation, SAS PhC/D implementation and operation, CDISC
  • Oracle Clinical/SAS interface development
  • Creation, implementation, and validation of SAS tool and macro program
  • Host SAS data migration
  • Analysis of data integration/business intelligence servers, integrated summaries of safety/effectiveness, and pharmacokinetics
  • Document creation support for consultation meeting specific to e-Data submission (Attachment 8)
  • Attendance at the PMDA consultation meeting
  • Response to queries
  • Medical affairs support
  • Periodic safety reports
  • Interim analysis
  • Analysis for reexamination application and theses
  • Compliance inspection support
  • Third-party program verification

Area experience

Urology, neuropsychiatry, pulmonology, cardiovascular medicine, gastrointestinal medicine, obstetrics and gynecology, otolaryngology, ophthalmology, vascular surgery, pediatrics, cancer, infection, anti-obesity, antivirus, in vivo diagnostics, Endobronchial Watanabe Spigot (EWS), transplant agent, and lifestyle

Past Experience

Supported clinical trials and postmarketing surveillance under a comprehensive multi-year contract with a major foreign pharmaceutical company:

 

  • Statistical analyses of clinical trials and postmarketing surveillance
  • Standardization in postmarketing surveillance
  • Consultation for statistical analysis, CSV, and ER/ES

*CSV: computerized system validation, ER: electronic record, ES: electronic signature

 

Supported clinical trials and postmarketing surveillance under a comprehensive two-year contract with a major foreign pharmaceutical company:

 

  • Statistical analyses of clinical trials and postmarketing surveillance
  • CSV support for EDC in postmarketing surveillance
  • Development of STARMACRO, a macro to standardize statistical analysis
    (The system was presented in the SAS user meeting)

 

Commenced CSV support of EDC for postmarketing surveillance:

 

  • Statistical analyses of clinical trials and postmarketing surveillance
  • Support for CDISC analysis dataset standardization
  • Consultation for CSV, and ER/ES
  • System implementation support for statistical analysis program standardization support tool
  • SAS validation
    • Training provided by experts
    • Participation in SAS user meeting (including presentations)
    • Participation in academic societies such as Japanese Society of Applied Statistics
    • Participation in CDISC Japan User Group
    • Writing and publications specializing in statistical analysis
    • Study meetings for statistical analysts on continuous basis
    • Taking a Bios course

*EDC: electronic data capture
Training for biostatistics experts by Union of Japanese Scientists and Engineers

 

Commenced contracted statistical analysis service in clinical development:

 

  • Development and sales of EXSUS* (a statistical analysis system of biological experimental data) and BESTS* (a biological equivalence trial system)
  • Clinical trial statistical analysis service (Contracted with at least 10 companies using at least 35 protocols)

*Supervised by Ryuji Uozumi, Senior Lecturer, Kyoto University

 


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