Biostatistics

Biostatistics

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.

BIOSTATISTICS_BROCHURE

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

180160140120100806040200 Phase I Phase II Phase III Phase IV IIT PMS Observation Study Epidemiology Medical Device Bridging Study Others

Therapeutic Area

553 Projects (Updated on 2019.12.31) Cardiovascular Oncology Endocrinology Gastroenterology Neurology Vaccine Orthopedics Hepatology Rheumatology Respiratory Others