再生医療等製品の開発支援サービス
Patient Centricity関連サービス
RBQM solutionサービス
AI･デジタルヘルス関連サービス
治験関連事業
Consulting / Regulatory services
In-Country Clinical Caretaker
Project Management
Clinical Pharmacology services (Phase I and BE trials)
Monitoring services (Phase II, III and IV trials)
Clinical IT Solutions
Data Management
Biostatistics
CDISC-related services
Medical Writing
Pharmacovigilance
Medical Imaging Analysis (Imaging CRO)
IP Management / Storage / Customs Clearance
Quality Assurance
Support for Regulatory Affairs
CRA and Other Supply / Dispatch services
Multinational Study
Post-Marketing Surveillance
Clinical Research
Medical Device Development
Regenerative Medicines Development
Software as a Medical Device Development
AI and Digital Healthcare
Food Development
Training
Regulatory Consulting Services
Conduct of/support to PMDA Consultations
Regulatory Services
CTD Preparation and Support
Clinical Trial Notification (CTN) Preparation and Submission
In-Country Clinical Caretaker (ICCC) Regulatory Services
Application Support for Cutting-Edge Technology and Orphan Drugs
Regulatory Procedure Consultation and Dossier Review
Pharmacovigilance Services
Clinical Trial Monitoring (Phase II/III/IV)
Feasibility Studies
Medical Institution and Investigator Selection/Survey
Clinical Study Conduct Requests and CTA Execution
Case Report Form (CRF) Collection
Source Data Verification (SDV)
Safety Information Provision and Reporting
CDISC-Related Services (CDASH CRF/eCRF Design, SDTM Conversion, ADaM Conversion)
Investigational Product Management, Storage, Delivery, and Collection
Custom Clearance Services
Quality Assurance Audits (MPI Teams, Medical Institutions, Systems)
Pharmaceutical Application Support Services
Medical Devices and In-Vitro Diagnostics Support
Approval application support
Marketing license application support
IVD approval application support
Veterinary medical device approval application support
QMS and GVP consulting
Insurance coverage consulting
PMDA and authority consultation
Pharmaceutical product application support
Document QC operations
CTD creation support
Foreign manufacturer accreditation support
Periodic GMP compliance inspection application support
RBQM solution services
Regulatory consulting services
Project management
Feasibility study
CTN preparation
Monitoring
Quality control
Data management
Medical writing
GCP audit
Support to build up a clinical trial network with the use of AI tools
Medical Image analysis
