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LSK Global PS analyzes the data and produces an appropriate assessment of the efficacy and safety based on the extensive knowledge and experiences of the experts in the field of biostatistics. LSK Global PS provides the comprehensive services beginning with the establishment of the statistical analysis plan reaching the analyses of data, preparation of outputs conforming to the CDISC standards, preparation of analysis reports, and consultation on statistics. LSK Global PS has wide experiences in the statistical analyses of diverse clinical researches and post-marketing surveillances as wells as clinical trials.
Brochure_Biostatistics
High-level Expertise
LSK Global PS helps its clients get optimal outputs by providing them with the most appropriate clinical trial designs and the clinical statistics services by 6 Ph.Ds in statistics of the clinical statistics field and a large number of statisticians with more than 10 years of experiences. LSK Global PS provides the highest level of services by reducing the total period of and allocated manpower to clinical studies since it suggests the proper method and time for analyzing them based on its ample experiences in the large scale clinical studies over a long period of time and the clinical studies on anti-cancer drugs in which the onset time and number of events determine the time to analyze them.
- Organization of LSK STAT department
LSK Global PS provides high-quality clinical study analysis reports by operating the organization of LSK STAT department systematically by dividing its members into statisticians, SAS programmers, and persons in charge of statistical research.
High Quality and Speed
LSK Global PS increases the work efficiency by automating the analysis program through the SAS programming, improves the accuracy and quality of outputs, and provides the services its clients need in an accurate and prompt manner by curtailing the analysis period.
Process
Protocol development
- Study design
- Statistical analysis method
- Sample size justification
- Randomization method
Statistical analysis process
- Assign study staffs
- Statistical Analysis Operation Procedure (SAOP)*
- Statistical Analysis Plan (SAP)
- ADaM specification*
- ADaM dataset* (Double Programming)
- Dry-run*
- Analysis population definition
- DB lock
- Unblinding of randomization code
- TFL generation (Double Programming)
- Writing statistical section in CSR*
- Archiving STAT document on SMF and e-files on SAS file server
- Deliver STAT deliverables to the sponsor
- * Depends on the contract
Service Scope
Statistical consulting and study design
Statistical programming and analysis
Sample size calculation and justification
Statistical report writing
(Adaptive) Randomization with IWRS
IDMC support for interim analysis
CDISC ADaM / Define-XML / Reviewer’s guide
Experience
Study Types
Therapeutic Area
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