Full Service CRO
Drug Development Services

High quality and Speedy Full-Services for Drug Development

Scope of Service


  • Nationwide-Study
  • Asian and Global-Study

[Major Services]

  • Clinical Pharmacological Test: Phase I
  • Monitoring
  • Data Management
  • Patient Registration Center
  • Statistical Analysis
  • Medical Writing
  • Pharmacovigiliance
  • Consultation, Regulatory and Others

[Clinical Pharmacological Test: Phase I]

  • We are working closely with SEHMA CO., LTD. in providing high quality PK/PD data, as well as supporting services on Statistical Analytic Planning, Data Management, and Monitoring for our clients.

  • -Clinical Trial Liaison Office
    -Preliminary Investigation
    -Central IRB Management/Audit
    -Clinical Trial Support Database Management
    -Volunteer members' enrollment/registration


  • Review of Medical Institutions and Investigators
  • Explanation of Protocol to Investigators on GCP compliance
  • Clinical Trial Plan Notification, Change Notification and Premature Termination/Completion Notification
  • Request Clinical Trials to Medical Institutions and Process Site Contracts
  • Response to IRB Review Results
  • Contracts Finalization
  • Arranging Startup Meetings
  • Supply and Collection of Investigational Products

[Data Management]

  • Design of CRF/DM
  • Design of Database / Design of an Entry Screen
  • Specifications of Logical/Manual Checks
  • Development of Data Management System and System Validation
  • Entry / Correction of Data / Coding
  • Performance of Logical Checks and Manual Checks
  • Development of DCF(CLF)
  • Development of Materials for Case Review Meetings
  • Database Lock
  • Analysis Data-Set

[Patient Registration Center]

  • Receipt of Subjects by Telephone / Fax / Web (Database Controlled Centrally)
  • Computer-aided Contracting with Medical Institutions and Registration Physicians
  • Balancing of Group Based on Prognosis Factors(Dynamic Assignment)
  • Assignment of Investigational Products for Use
  • Report of Entry Omissions and Discrepancies
  • Eligibility Assessment in Accordance with Protocol
  • Management of the Status of Enrollment

[Statistical Analysis]

  • Protocol Development (Analysis-Related Portions, Sample Size Design,etc.)
  • Development of a Statistical Analysis Plan
  • Analysis Program, Output of the Results and Performance of Validation
  • Interim Analysis
  • Preparation of an Analysis at a Key-Opening Meeting
  • Statistical Analysis Report
  • Clinical Study Report (Analysis-Related Portions)
  • Analysis for Development of an Application Dossier (in response to CTD)
  • Consulting for Analysis Activities of Clinical Trials

[Medical Writing]

  • Adverse Drug Reaction Reports, Clinical Study Reports
  • Documents for Clinical Trials
  • Post-Marketing Clinical Studies,
  • Clinical Trial Plan Notifications,
  • Protocol
  • Informed Consent Written Information,
  • Case Report Forms
  • Investigator's Brochures
  • Approval Applications and Reexamination Applications (Application Dossiers in Response to CTD, Reexamination Application Dossiers)
  • Thesis Papers, Articles, etc
  • Orphan Drug Designation Application Forms
  • Preparation or Revision of Interview Forms
  • Translation of reports (English and Japanese)


  • Preparation/ Regulatory Submission (Domestic and Overseas):

  • -CIOMS/MedWatch Forms
    -Research Reports
    -Adverse Drug Reaction
    -Infection Case Reports
    -Measure Reports
    -Defect Report
    -Various reports/documents for internal Safety Committees, HQ and Overseas Affiliates, etc.
  • Primary Assessment/ Translation Services(English and Japanese)

  • -Clinical Trial/ Post-Marketing Safety Information -Overseas CIOMS/MedWatch Form
  • Support for Instructions to Monitors and MRs
  • Consultation for General Pharmacovigilance and related activities
  • Consultation by Contract Specialist Physicians for Adverse Events

[Consultation, Regulatory and Others]

  • Planning of Development Strategy, Clinical Trial Plans, and Various Reviews
  • Consultation for Licensing in from Overseas and for Clinical Trials in Foreign Countries
  • General/regulatory Consultation for Development of Drugs and Medical Devices
  • Support for Studies in Humans on Health Food and Health Supplements
  • Support for Investigator-Initiated Clinical Trials, Large-Scale Epidemiological Studies, etc.
  • Support for Bioequivalence Studies on Generic Drugs and Applications
  • Preparing and registration of Master File