Chairman's Message
Since its establishment in 1994, our association has been a group of companies supporting various activities related to clinical trials. We have worked together towards the proper establishment, stabilization, and development of CROs through the cooperation among our member companies. This year, we are celebrating our 30th anniversary. Currently, the association has 49 member companies (13 regular members and 36 associate members), with an annual revenue of approximately 250 billion yen in 2023 and a total of about 20,000 employees.
In the first ten years after its establishment, our focus was on raising awareness to demonstrate the value of CROs. In the subsequent ten years, our main efforts were directed towards improving quality through human resource development and other initiatives. Over the following decade, our scope expanded to include not only pharmaceuticals but also medical devices, regenerative medical products, post-marketing activities and related IT services. We have grown to become an indispensable entity in the development processes of pharmaceuticals and medical devices. We are deeply grateful for this success thanks to your great support and encouragement from all of you.
In recent years, the environment of clinical trials has undergone significant changes due to digitalization, increased patient involvement in clinical trials, and the use of Real-World Data. CROs can no longer sustain themselves with traditional business models alone. There is a growing need to expand business scopes and collaborate with various stakeholders. Particularly, integration with technology has become essential. Currently, our association includes system vendors and database companies. Moving forward, our association will continue to act as an intermediary for companies involved in clinical trial processes, offering various proposals to pharmaceutical companies, medical device companies, medical institutions, and governmental bodies to improve efficiency and quality. We are committed to contributing to the driving of pharmaceutical and medical device development, post-marketing activities, and other related operations.
On the other hand, Japan's drug lag and drug loss have recently become societal issues. While there are various causes, one factor cited is the challenges associated with clinical trials in Japan. Clinical trials in Japan have traditionally been renowned for their high quality; however, there are concerns about complex procedures, low patient accrual, lack of transparency in costs, and slow digitalization. As global drug development has become the norm in these days, Japan is increasingly seen as losing its appeal as a site for new drug development. As a key player in clinical trial-related activities, the CRO Association is committed to actively addressing these challenges and working towards restoring Japan’s position as a leader in new drug development on the global stage.
Furthermore, although CROs are contracted to perform certain tasks, they are able to approach their work from an independent standpoint. It is extremely important for each CRO to maintain high ethical standards and adhere to compliance regulations. Ensuring the reliability of contracted work and the trustworthiness of the data obtained is our top priority, and we will continue to address these various tasks with this focus in mind.
Moving forward, we will continue to work on revitalizing clinical trials in Japan, ensuring that better pharmaceuticals, medical devices, and regenerative medical products reach patients more quickly. We are committed to further advancing Japan's healthcare industry. All our members will strive to achieve these goals, and we kindly ask for your continued guidance and support.
