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.
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.