Services

DOT WORLD is a Japanese full-service CRO providing best practices for Japanese clinical trials as well as consulting services to design optimal clinical development plans for Japanese New Drug Applications (NDAs).
We are a mid-size organization characterized as totally customer-focused and we create the best possible profit for our clients.
We are experienced in supporting Japanese NDAs including negotiations with Japan's Pharmaceuticals and Medical Devices Agency (PMDA), using the Common Technical Document (CTD) format. We have made submissions with this format for the past 7 years with 4 NDAs.
In addition to sponsor-initiated trials, we also conduct investigator research which hepls us to gain the deep trust from local medical specialists. They get a chance to experience our timely, cost-effective and quality services.

Our mission is to shorten the time-line for the clinical development of medicines and medical devices for their manufacturers. Bringing these products to market sooner will help patients in need.
We contribute to the early launch of new medicines and new devices through the efficient execution of clinical trials. We are eager to serve an important role in your developmental process.

Takumi Information Technology

TFS International

Based in California, ClinDatrix is a full-service CRO with excellent coverage in North America and an established partner network across other continents. The firm hosts their own global EDC capability using Oracle's software, industry recognized to offer best functionality. Other sponsor-selected EDC systems can be used as well. Together, DOT and ClinDatrix offer our clients comprehensive clinical research services in Japan, the United States and around the world.

Tetsuya Orito
COO

Mr. Orito is the founder of DOT WORLD. He is responsible for directing and managing all company activities including regulatory negotiation, operation, clinical trials and market consulting.
Mr. Orito has over 20 years of experience in all phases of clinical development. He served in Yamanouchi Pharmaceutical and Astellas Pharm Inc. for 15 years prior to founding DOT WORLD.
Mr. Orito has supported both small biochemical and large pharmaceutical companies. He has led full clinical development projects and successes in NDAs and PMDA applications. In addition to his depth of knowledge and experience, his enthusiasm to develop new safe and efficacious medical treatments is the crucial key that leads to the success of our clients.

JCROA CDISC

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DOT WORLD Co., Ltd. Comodio Shiodome 4F, 2-14-1 Higashi-Shimbashi, Minato-ku, Tokyo, 105-0021, Japan