Data Science Specialists Support Life Innovation Business

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Services

Data management and statistical analyses integrated services
（We provide speedy and cost efficient consultation and practical services, from translational research to clinical development and/or study design to report writing.）

Statistical consultations

・Clinical study design

・Rationale for sample size estimation

・Advice and attendance to PMDA (Japanese regulatory authority) meetings

・Interim analyses and adaptive design

・Drafting and review SAP (statistical analysis plan)

・Drafting and review data management plan

・Drafting and review study protocol

・PK/PD simulation and clinical trial modeling

・Biomarker strategy

・Imaging study planning based on imaging charter

・Biobanks and epidemiological studies

・SOP (standard operation procedure)

・CSV (computerized system validation)

・Training and preparation of education program

CRO Liaison for Japanese customers

・Drafting and review CSR (clinical study report)

・Quality management of Japanese/English translation (prepare pair translation database)

・Data translation (SOP to use translation support system)

・Support Japanese customers to conduct data management, statistical analyses and medical writing in English

・Project management with CROs

・Introduce CROs and support RFP (request for proposal) in English

・Evaluate ROI (return on investment)

・CDISC consultation

・Clinical trial data archive

・Clinical study support for medical institutions

・Distribute and support ELN (electric laboratory notebook)

・ELN new module/interface development

・Create internal portal site/knowledge base (clinical study design, biomarker, imaging study, biobank, etc.)