DOTワールド Company Profile

We provide a comprehensive range of services necessary for the project, from regulatory response to post-marketing surveillance.

Business Activities 1. Management of clinical trials and clinical research 2. Data management and statistical analysis 3. CDISC compliance 4. Medical writing 5. Clinical trial consulting 6. Support for post-marketing surveys, etc. 7. Domestic clinical trial management 8. Safety information management 9. Auditing of clinical trials 10. Regulatory affairs Track Record (32 corporate-sponsored clinical trials, 47 investigator-initiated trials, 1 corporate-sponsored clinical research study, 67 investigator-initiated clinical research studies, 4 society-led clinical research studies) ◆ Areas Oncology, central nervous system, urology, orthopedics, gynecology, medical devices, regenerative medicine, etc. ◆ Development Stages Clinical pharmacology studies, Phase 2 trials, Phase 3 trials, post-marketing clinical trials, investigator-initiated trials, clinical research, etc. Our achievements span a wide range of areas, primarily focusing on rare diseases and, more recently, regenerative medicine. If you have any questions, please feel free to contact us.