- Validation, Consulting, Development and operation/Maintenance service ranging from drug discovery/Non-clinical research, Clinical development, Regulatory submission and post-marketing operations to pharmacovigilance activities
- Implementation, Operation/Maintenance for Tools and Packaged Software Applications for Creation of Regulatory Submission documents, Post-marketing surveillance, Communication management for information on proper use, and EDC/EDC for PMS, and Computerization of NDA submission activities.
- Mission-critical and sales system solutions as well as implementation, Improvement, Operation/Maintenance of agency management package systems
Pharmaceutical Contract Research Services
- Clinical operations (quality assurance and document management for clinical trials)
- Medical writing
- Drug allocation
- Patient registration/allocation/progress management
- Data management/statistical analysis
- CDISC standardization support
- Statistical analysis standardization and SOP revisions, etc.
- SAS Drug Development （SDD） implementation support
- Application-related consulting and outsourcing
- Global application support
- Medical writing
- Public document masking
- PDF conversion and report publishing
- Contracting, registration, progress management support
- Data management and statistical analysis
- PMS standardization support and SOP revision, etc.
- Pharmacovigilance support
- Data migration
- RMP setup, implementation, evaluation, and review
- Vital risk monitoring/safety precaution support
Services across all areas
- Support for Implementation of Software Applications
- CSV Consulting
- ER/ES Regulation Support
- Support for SOP Development
Special Features of Our Services
Full array of support offerings with IT and business operations
From individual system development tailored to client needs to package implementation support, we offer thorough and flexible solutions in all phases of drug development from both IT and business perspectives.
High quality service proven by experience and expertise
We provide comprehensive training and education both inside and outside the company to develop specialized personnel and enhance the quality of our services. Plus, we offer IT implementation and business services based on a wealth of experience and knowledge.
Seamless system support offering for all areas, from its selection to operations
We offer seamless support, from selection of vendors for drug manufacturing systems through SOP development, implementation consulting, system integration, system validation, and to operation/maintenance.
Support available for any systems
We have a wealth of experience in services utilizing third-party package systems in EDC and pharmacovigilance, enabling us to provide implementation, improvement and maintenance for in-house and external systems.