With the time and cost involved in clinical development increasing, R&D productivity is declining and the pipeline is being reduced. New regulatory requirements are making this process more complex. Additionally, with the globalization of drugs, the same drugs are now being used all over the world, but the classifications of development stages and commercialization stages for these drugs differ by country. Moreover, after commercialization, in addition to safety testing, there has been significant expansion of the development of new indications, risk/benefit analysis and efficacy evaluations etc.
Seeing the rapidly changing environment of pharmaceutical and biotechnology companies as an opportunity, the Quintiles Group recognizes the challenges of its customers, and creates innovative solutions to overcome these challenges.
Our Clinical Development Services provides the following services:
- Clinical trial activities from Phase I through Phase IV
- Clinical monitoring
- Data management
- Statistical analysis & imaging
- GCP audit, clinical study site audit
- Support in consultation with Japanese regulatory agency PMDA
- Regulatory consultation
- Assistance in safety information management
- Support in application for approval
- MedDRA support and maintenance
- Medical writing
- In-Country Clinical Caretaker (ICCC) service
- Support for multinational study (global study/Asian study) projects
- Support for simultaneous development in Japan, Europe and the US
- Clinical trials and related activities outside of Japan
- PMS (post-marketing surveillance and post-marketing clinical trials)
- ECG analysis
We provide solutions customized to the needs of customers to achieve the best possible results in all the above areas.
- Click here to listen how multinational companies without a local presence can improve their probability of success in Japan.
- Click here to learn how Quintiles Japan can help you develop untapped local market potential.
- Click here to learn how local partnering with Quintiles Japan can open global opportunities.