Medical Science Services for Real World Data Study

Medical Science Services for Real World Data Study

Service

We provide medical science services for real world data study in all processes involved in developing and conducting a protocol (framing a hypothesis, designing study, analysis, and writing papers) as follows:

  • Research question development
  • Protocol development
  • Consulting for process development
  • Consulting for selecting database
  • Analysis including exploratory survey and sensitivity analysis
  • Writing and submission of papers in English and Japanese.
  • Drug use survey using administrative healthcare data
Process Description
Framing hypothesis We identify research questions, frame a hypothesis based on study objectives and past papers, and establish a relevant summary of a protocol as “a draft of protocol summary” based on its feasibility.
Designing
  • We finalize a protocol summary based on the draft. Based on the finalized summary, we develop a protocol.
  • We provide consulting services for selecting and purchasing databases.
  • When databases have been already obtained, we conduct exploratory analysis if needed prior to regular analysis in order to collect information for understanding study results.
Analysis
  • We conduct analysis based on a protocol and carry out sensitivity analysis if needed.
  • We provide consulting services including reviewing requirement definitions of data extraction so that appropriate analysis can be carried out.
  • We create internal reports.
Papers We write and submit papers in English and Japanese.

Support Structure

We offer the following complete support for each process:

  • Appointment of person responsible for Good Post-marketing Study Practice (GPSP)
  • Appointment of person responsible for Good Vigilance Practice (GVP)
  • Consultant team for protocol development
  • Analysis team specialized in pharmacoepidemiological studies
  • Writing and submission of papers in English and Japanese
  • Appointment of academia advisor
  • Collaborative studies with academia

Our medical science services for real world data study


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