Tel:+81-3-5843-8480 Tokyo office
Tel:+81-78-219-4626 Kobe office
Services: Clinical Trial Service

Pharma Training consultants will assist sponsers with all phases of the clinical trial process.

A. ESTABLISH PROJECT PLAN of pharmaceutical product and/or medical device based on regulatory strategy and scientific/medical evidence (study reports).

B. PRECLINICAL STUDY CONSULTATION
  1. Preparation of preclinical study reports for pharmaceutical product and developmental regulatory reports for medical device
  2. Consultant service for preclinical studies Eul>
  3. Drug: Pharmacology, Toxicology, ADME, CMC
  4. Medical Device: Use & method, stability & endurance, performance, risk analysis, manufacturing method, etc.
  5. Pre-application of biopharmaceutical product before IND (start of clinical trial)
C. CLINICAL TRIAL CONSULTATION
  1. Preparation of GCP documents
    • Clinical Study Project Plan
    • Efficacy and Safety Evaluation Committee
    • Selection of Investigators and Participating Medical Institutions
    • Creation and Revision of Investigator's Brochure
    • Creation of Study Protocol (Clinical Investigational Plan) and Samples of Case Report Forms
    • Cooperation on the Creation and Revision of Informed Consent Forms
    • Protocol Review Committee within Sponsor
    • Health Impairment Compensation Policy for the Subject
    • Study Request, Contract, Changes and Conclusions
    • Study Training (Internal and External Personnel)
    • Procedure for determining delivery permission/rejection of investigational product for import
    • Investigational Product Accountability
    • Clinical Study Registration
    • Monitoring
    • Receipt and Confirmation of Case Report Forms
    • Data Entry/Revision
    • Statistical Aspects of Study Development
    • Final Study Report
    • Termination of the Study and Product Development
    • Quality Control
    • Training for Clinical Study Stuff in Sponsor and/or CRO
    • Creation, Revision and Abolishment of SOP
    • Storage and Management of Records
    • Handling of Serious Adverse Event (and Malfunction) Reports
    • Emergency and Compensation Use/ Humanitarian
    • Preparing for Inspection by External Agencies
    • GCP-QC
    • GCP-Audit
  2. Project Management of Clinical Trial
  3. Translation for GCP Documents in English and Japanese
  4. Preparation for PMDA Meeting Documents regarding Protocol Outline based on the strategy
  5. Preparation of answer documents against PMDA question for Clinical Study Protocol, etc.
  6. Preparation of CTD for Submission in English and Japanese
D. TRAINING SERVICE
  1. GCP Training
  2. GVP Training
  3. GQP Training
  4. SOP Training