Data science is being leveraged to streamline clinical development processes. From a data management (DM) perspective, the Biometrics Department is actively introducing and evaluating new systems and solutions for decentralized clinical trials, which are being promoted across the Clinical Development Division. This article explores the potential of pursuing innovative drug development through digital technology.

 

*Reprinted from Chugai's official talentbook (https://www.talent-book.jp/chugai-pharm). The descriptions and affiliations are current as of May 2025.

Data Science Opening the Door to Next-Generation Drug Development

The Clinical Development Division plays a critical role in promoting innovative drug development and providing new treatment options. Within this division, the Biometrics Department accelerates pharmaceutical innovation by utilizing data science to enhance clinical development processes.

Minagawa　"The mission of the Biometrics Department is to maximize operational efficiency and drug value. From the perspectives of data science and regulatory science, we design and plan trials, manage data collection, and prepare materials necessary for approval applications.
Our Data Management Group’s primary responsibilities include data collection for global and domestic clinical trials, creating case report forms, reviewing various documents, and managing data cleaning.
Beyond these tasks, we are advancing data utilization and strategic initiatives to further enhance Chugai's product value and improve overall operations beyond the framework of clinical trials."

Mitsui　"The primary goal of clinical trial data management is to handle data from development to approval and ensure its quality. Meanwhile, as part of our efforts to enhance product value and operational efficiency, we are exploring how to use the collected data beyond specific clinical trials or approval applications.
For example, we are investigating ways to conduct trials more efficiently and in shorter periods by focusing on all data generated during clinical trials, including past operational data. We believe these efforts will not only improve pharmaceutical operations but also help deliver necessary medications to patients more quickly."

Minagawa　"It's not uncommon for information collected in one clinical trial to be valuable for other trials or future developments. Comprehensively supporting the entire trial process as data managers, including such scientific possibilities, is a critical role of our Biometrics Department."

Data Leading a New Era of Healthcare: Working Toward Patient-Centered Clinical Trials

Mitsui focuses on DM in both global and domestic clinical trials. Mitsui is also promoting decentralized clinical trials and industry activities aimed at realizing new patient-centered clinical trials.

Mitsui　"In recent years, clinical trials have rapidly digitalized through technologies and services such as online medical consultations, wearable devices, and visiting nursing care.
While enabling trial activities at locations beyond conventional facilities, such as patients' homes or local medical centers, is expected to significantly reduce patient burden, the challenge lies in managing and utilizing the resulting dispersed data. We are exploring ways to efficiently manage and leverage this data.
I also participate in the activities of the 'Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Data Science Subcommittee,' an industry organization promoting the use of data science in drug development. This group aims to develop innovative pharmaceuticals by actively exchanging information and knowledge."

Minagawa focuses on enhancing product value and operational efficiency through data utilization, in addition to managing clinical trial data. She is particularly concerned with the proper management and utilization of clinical trial data.

Minagawa　"To create an environment where various departments can easily understand 'what data exists where,' I manage and operate the Data Steward system, which includes storage and metadata management for clinical trial data.
Additionally, as a business member of the new 'CoDaMa' project, a cloud-based data management system developed by Chugai, I am involved in various tasks such as system specification discussions, CSV [Computer System Validation] document creation, test implementation, operational procedure considerations, and manual development.
As part of industry activities, I also help share information with other companies and provide feedback to our organization based on the knowledge gained."

Minagawa and Mitsui, both at the forefront of data utilization, describe the appeal of working in data management at Chugai as follows:

Minagawa　"I began my career at a Contract Research Organization [CRO]. I chose data management over clinical trial monitoring because I found the process of considering optimal data collection methods appealing, similar to manufacturing.
I joined Chugai because the company was actively engaged in data utilization. I was drawn to the opportunity to participate in advanced analysis and strategic decision-making."

Mitsui　"Having been interested in data handling and analysis since my student days and having researched clinical trial-related themes, Chugai, with its focus on data science, was an ideal environment for me.
As I anticipated, there is a culture that encourages new challenges. Additionally, the company has systems in place that allow even young employees to make proactive proposals, such as regularly soliciting new digital-related ideas internally.
I also believe our partnership with Roche is one of our key strengths. While implementing digitalization and automation can be time-consuming and costly, the ability to refer to Roche's pioneering examples is a significant advantage that other companies don't have."

Promoting Clinical Trial Digitalization and Operational Efficiency: Changing Medical Norms Through the Power of Data

Chugai Pharmaceutical announced "CHUGAI DIGITAL VISION 2030" in 2020, positioning the enhancement of digital infrastructure as a core strategy. The vision emphasizes Chugai's unique ability to leverage advanced data utilization to achieve objectives that others cannot.

Minagawa　"In 'CHUGAI DIGITAL VISION 2030,' our goal is to drive business innovation through data-driven decision-making. The first step toward this is ensuring that data is managed in a manner that facilitates its easy use. I am involved in the construction and operational management of 'CoDaMa,' a clinical trial data storage system. We have implemented systems that make data easier to utilize by establishing efficient storage mechanisms and understanding the types of data being stored. Many companies still lack storage management systems designed for clinical trial data utilization, which highlights the advanced nature of Chugai's initiatives. The ability to take on such sophisticated challenges is made possible by our company's emphasis on practical DX [digital transformation] and a culture of 'let's try it first.' As someone who works with data, this is highly fulfilling."

Mitsui　"I am leading a project to automatically link electronic medical records with EDC [Electronic Data Capture] systems [used to electronically collect and manage data from clinical trials]. Previously, facility staff manually transcribed electronic medical record data into the EDC system, and monitors verified this data against source documents. By automating this process, we eliminate the need for manual input, improving data quality and operational efficiency. However, electronic medical record data formats vary across institutions, and many are unstructured, which complicates integration. There is a strong sense of accomplishment in tackling these challenges as a team while advancing the digitization and automation process."

In addition to digital innovations, Chugai is also exploring non-digital advancements:

Minagawa　"I am currently involved in designing a new trial format called a 'basket trial,' which is unprecedented at our company. This type of trial simultaneously develops treatments for multiple diseases under a single protocol. While the trial preparation and operation are complex due to the variety and volume of data and the different evaluation methods for each disease, it offers significant benefits by streamlining development.

Leveraging my experience as a data manager, I am finding many unique challenges and learning opportunities in basket trials. Being able to contribute to such innovative trial designs is also a hallmark of Chugai."

A Supportive Environment Fosters Talent: Advancing to the Next Phase with Diversity as a Strength

Both Minagawa and Mitsui emphasize that they can fully realize their potential due to Chugai's supportive work environment. They describe the appeal of working at the company as follows:

Minagawa　"I find it very comfortable here, surrounded by approachable colleagues, whether they joined as new graduates or mid-career professionals. In particular, the Data Management Group consists of members from diverse backgrounds, including those with experience in research, CROs, and system vendors. It is an ideal workplace for those looking to take on new challenges, regardless of their area of expertise or who want to drive change using data. The flexibility of working from home is also an attractive feature. We go to the office as needed, and when we do, we often gather in the newly opened cafeteria on the 17th floor. The environment here has been instrumental in helping me maintain a healthy work-life balance."

Mitsui　"One of the reasons I joined Chugai was because I was drawn to the people, and that impression has not changed. The accessibility of supervisors and the collaborative spirit, regardless of whether one is a new graduate or a mid-career hire, make the workplace very appealing. The environment, where even younger employees can freely express their opinions, is a unique aspect of our company. We welcome individuals who are willing to take on challenges and adapt flexibly to changing circumstances."

The work of these two data managers, who are streamlining clinical development through data science and promoting innovative drug development, is just beginning.

Minagawa　"I want to continue contributing to creating an environment where individuals can freely access necessary data and use it for decision-making. In the future, I aim to develop new skills that will enable me to take on a consultant-like role, offering recommendations on how data can be effectively utilized."

Mitsui　"I am still exploring my career path, but I want to remain involved in data management. This field offers a wide range of career possibilities, and I seek diverse experiences that will help me clarify my goals and broaden my professional horizons."