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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
- Preparation of preclinical study reports for pharmaceutical product and developmental regulatory reports for medical device
- Consultant service for preclinical studies
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- Drug: Pharmacology, Toxicology, ADME, CMC
- Medical Device: Use & method, stability & endurance, performance, risk analysis, manufacturing method, etc.
- Pre-application of biopharmaceutical product before IND (start of clinical trial)
C. CLINICAL TRIAL CONSULTATION
- 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
- Project Management of Clinical Trial
- Translation for GCP Documents in English and Japanese
- Preparation for PMDA Meeting Documents regarding Protocol Outline based on the strategy
- Preparation of answer documents against PMDA question for Clinical Study Protocol, etc.
- Preparation of CTD for Submission in English and Japanese
D. TRAINING SERVICE
- GCP Training
- GVP Training
- GQP Training
- SOP Training
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