InCROM CRO

InCROM CRO Inc.

Featured Services

  • ■ Speedy and high-quality service by well-experienced staff
  • ■ Data Management of Case Report Forms for various medical institutions
  • ■ Statistical and PK/PD Analysis using SAS software which satisfies the demands of our customers
  • ■ Preparation of Study Protocol and Clinical Study Report based on wealth of experience
  • ■ Consistent Quality Control and Quality Assurance from Monitoring, Data Management to preparation of Clinical Study Report
  • ■ Up-to-date Clinical Trials such as QT/QTc, biosimilar, and microdose studies
  • ■ One-stop service from consultation to GCP Audit
  • ■ Other tasks as requested by clients

Work Contents

■ Clinical Monitoring Service and GCP Audit

  • Confirmation of required conditions of Principal Investigators and Sub-Investigators
  • Confirmation of required conditions of Responsible Medical Expert
  • Request clinical trials to medical institutions and response to IRB Review
  • Explanation to Investigators and CRC staffs
  • Management of Essential Documents
  • Monitoring
  • GCP Audit of Study Sites and CROs

■ Data Management (DM)

  • DM Plans
  • Database Design
  • Data Entry/Validation
  • Manual/Logical Check
  • Database Locks

■ Statistical Analysis (SA)

  • SA Plans & Production of SA Reports
  • Subject Data Listings
  • Production of Figures & Tables
  • Document Preparation for Case Review Meetings

■ Medical Writing (MW)

  • Protocol (Draft)
  • Case Report Forms (Draft)
  • Informed Consent Forms (Draft)
  • Investigational Brochures (Draft)
  • Clinical Study Reports (Draft)

■ CDISC (Clinical Data Interchange Standards Consortium)

  • CDASH (Clinical Data Acquisition Standards Harmonization)
  • SDTM (Study Data Tabulation Model)
  • ADaM (Analysis Dataset Model)

■ EDC/CDMS

  • Medidata Rave
  • Viedoc

■ Others

  • Support of academic articles
  • Translations (English)
  • Consultations for clinical study design, etc.