Yukio Mukai

Clinical Trial Business

Associate Director, Head of Clinical Research Management, Contract Medical Affairs

Yukio Mukai

Contract medical affairs are becoming increasingly important

Contract medical affairs are becoming increasingly important

While new drug development is referred to as “innovative drug development”, preserving and increasing the value of pharmaceutical products after approval for manufacture and sale is known as “contract medical affairs” — a field of activity that is becoming increasingly important as a form of life cycle management for pharmaceutical products. Over recent years, a succession of scandals relating to clinical research has become an issue of public concern, leading to demands for greater transparency in terms of cost and ensuring reliable data. At the same time, pharmaceutical companies have set up medical affairs departments, to swiftly respond to the needs of conducting clinical research, and in April 2018 “Japan’s Clinical Research Act” came into effect. It is expected that under these laws, the post-marketing clinical research conducted by companies will focus increasingly on their own field of treatment in the years ahead.

Establishing a full package system to accept contracts for all kinds of clinical research

Establishing a full package system to accept contracts for all kinds of clinical research

Since 2011, Linical has been contracted to conduct post-marketing clinical research support and clinical monitoring. We have handled not only clinical research on pharmaceutical products, but also a variety of other kinds of clinical research, including non-interventional observational research and database research. Furthermore, Linical has also successfully executed contracts in which it has complied with strict “Ethical Guidelines”, as well as with “ICH-GCP” relating to clinical research aimed at conducting global studies and ultimately publication in overseas scientific journals.                        

Linical have the ability and experience to work across multi-disciplinary aspects of clinical research, delivering a full package of services, ranging from the formulation of clinical research plans based on “Ethical Guidelines”, “ICH-GCP”, and “Japan’s Clinical Research Act”, to implementation support, monitoring, data management, bio statistical analysis, inspection/auditing, and support for research paper publication. In this way, we engage in clinical research that contributes to the advancement of medical treatments.