We provide clinical data management and statistical analysis services for a wide range of therapeutic areas covering all phases of development, from clinical to post-marketing surveillance.
When providing services, our experts in pharmacology and biostatistics take prompt measures in accordance with regulations governing GCP, GPSP and other practices while ensuring that the highest quality standards are observed. Our system flexibility and operational know-how enables us to process large amounts of clinical study data quickly and accurately.
- Registration
- Central registration by fax, mail, or the Internet Eligibility check
- Progress management
- Preparation and assessing protocols and CRFs
- Preparation of data management operation manuals
- Database design, data entry screens and system validation implementation
- Data entry, correction and coding
- Creating and evaluating specifications for logical checks
- Making logical check programs and implementation system validation
- Data input/editing coding
- CRFs checking including, implementation of logical and manual checks, and queries
- Preparation of materials for review meeting
- Drafting of data handling and selection criteria
- Listing up of questionable or problematic cases
- Preparation of subject outline
- Data management operation report
- Consulting on overall statistical analysis
- Develop clinical trial implementation plans/study design
- Develop statistical analysis plan
- Develop program for statistical analysis and validation implementation
- Implementation of statistical analysis (creation of graphs and tables)
- Creating statistical analysis reports
- Investigator meeting support
