Customer Story

Addressing Compliance Requirements with Agatha at Tohoku University Hospital

When The Clinical Research Data Center at Tohoku University Hospital needed a more efficient and effective way to manage clinical and quality documents, they chose Agatha.

Details

Compay Name: Tohoku University
Industry: Clinical Research
Website: http://square.umin.ac.jp/compl/

The Japanese Association for Complement Research (JACR) was founded to further progress in the area of complement research and its related areas, promoting academia as well as science and technology, by making complement research results publicly available, and fostering collaboration and cooperation with domestic and international affiliated academic organizations.

The Japanese Association for Complement Research (JACR) engages in building an association-led framework for complement testing and new research and development projects that improve the understanding of complements and the development of new diagnostic methods.

The complement system (a group of proteins) works with the immune system to fight off infections and destroy foreign substances, including viruses and bacteria. Complement testing is the process of diagnosing diseases caused by abnormalities related to complements. 

JACR is leading clinical projects on complement testing which involves multiple facilities and companies conducting the testing. Initially, JACR relied on emails to send testing data and CRFs but there were concerns with data security. As a result, JACR decided it needed it a solution that could enhance operational efficiency and security.

Researchers at other institutions recommended Agatha to JACR and after a review, it decided to move forward. JACR plans to increase the use of Agatha to include management of clinical research projects for other diseases, as well as IRB applications and operational documents such as board and other meeting minutes.

“When we accessed Agatha, we were using it intuitively from the get-go. Other vendors’ systems were flexible and had all sorts of features but this meant that we had to think about how we wanted to use all these features and decide for ourselves. We’d heard that when you try to use a highly flexible system with a group of people who are not familiar with it, things can get out of control because some are bound to start doing things their own way. So that was a concern. 

Agatha, on the other hand, presented the features necessary to manage clinical documents, all wrapped neatly in a very simple user interface. We felt sure team members would be able to use it without getting confused.”

Keiko Takano, Yasuo Fukumori, and Toshiko Yasuda from The Japanese Association for Complement Research (from upper left), Professor Norimitsu Inoue of Osaka International Cancer Institute, and Assistant Professor Yoshihiko Hidaka of School of Medicine, Shinshu University

Before Agatha – The Challenges

  • Sharing information among many locations and groups via email
  • No version tracking or audit trail to record changes to files
  • Manual review process
  • High-security risk due to insecure emailing processes

With Agatha – The Benefits

 

  • Better and easier communication and fortified security
  • Fully version tracking and audit trails of documents.
  • Configurable automated review process
  • Intuitive user interface and user friendly, even for inexperienced users
  • Cloud-based, so it can be accessed by any type of computer
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