The Support Network for Clinical Development (SMONA), a cooperative
The company was approved by the Kanto-Shinetsu Health and Welfare Bureau of the Ministry of Health, Labour and Welfare in May 2001 based on the Small and Medium Enterprise Cooperative Association Law.
We are the only cooperative in this industry in Japan.
In order to improve the accuracy and speed of clinical trials, clinical trial support providers work daily.
In order to cope with the new era in the severe economic environment, and to overcome the constraints of small and medium-sized companies and the challenges faced by companies on their own, we will continue to develop our business.
Clinical trial support providers, mainly SMOs and CROs, will collaborate with each other to
SMONA is an organization that aims to contribute to society for patients who are waiting for new drugs.
What was the reason for introducing learningBOX?
SMONA is a cooperative of companies that support clinical trials, and its strength lies in the ability of its member companies to work together to address issues. The cooperative was started based on the conviction that there are many things that can be achieved if small and medium-sized companies work together in the spirit of mutual support. In clinical trials, CRCs (clinical trial coordinators) support the progress of clinical trials at the medical institutions where they are conducted under the direction of the investigators. For this reason, it is important to educate CRCs who belong to member companies, and in addition to in-house training and union training, there was a suggestion that it would be good if we could use e-learning for efficient training. We did a lot of research before introducing it. Of course, we had a limited budget, so cost was very important. Equally important was the ease of use: how easy it was for the e-learners to learn and acquire knowledge, and how easy it was for the question writers to use. I'm in charge of operation and management, so that was also important. I'm a very analog person. (laughs) When we first talked about introducing the system, I thought, "I'm going to manage it? That's impossible. (laughs) But since it was a request from a member company, I was thinking about which of the many systems would be easy to use, and that's when I came across learningBOX. The system of learningBOX cleared both of them.
There are many different companies participating in the cooperative, and you are in a situation that requires highly specialized content. What exactly will you learn?
The main participants of the learningBOX system are CRCs from union member companies. GCP is an ordinance that outlines the standards that companies and medical institutions must follow when conducting clinical trials of pharmaceuticals. The GCP provides rules to protect the human rights and safety of participants in clinical trials to the maximum extent possible and to accurately investigate the efficacy and side effects of clinical trials using scientific methods. In order to become a CRC who is trusted by patients, medical institutions and sponsors, you are required to understand GCP correctly.
That's a tough one...CRCs need to fully understand GCP content, right? So, do you make contents to learn GCP?
Yes, this course is designed to teach GCP in CRC work.
Basically, GCP is learned through in-house training and on-the-job training at each member company, so this GCP training is positioned as a training to establish and confirm the knowledge of GCP that has been learned at each company.
So, as a union, you use e-learning to conduct tests and other activities to establish standards for this level of performance.
Yes. First of all, our goal is to have all of you get 100 points in this GCP training. SMONA also conducts the CRC certification exam once a year, and those who pass it become SMONA certified. Since the introduction of the learningBOX, we have also been using this test to support the continued certification of certified personnel. In addition, GCP is subject to revision, so things that were OK before may become against the rules due to revision. In this sense, there is an advantage of being able to continuously update new knowledge, not only for new CRCs but also for anyone regardless of their career.
Does Mr. Shiraki make the actual problems? How do you operate it?
Since the content is highly specialized, the questions are prepared mainly by educators from member companies, who participate as SMONA education and training committee members. Final adjustments are made through email communication and monthly meetings.
In GCP training, answers are not only "0" or "1" but also "2" or "3". We consider the explanation part to be important, and try to provide explanations so that trainees can understand what is important after answering the questions.
We have set a deadline of one month for answering each new question. Repeating the questions will help you retain the knowledge.
After each GCP training session, we use the results management function to check the results.
I also appreciate the ability to set up groups for each company in the member management.
You've done a great job of structuring it! Is there any e-learning other than learningBOX that you were unsure about while considering implementation?
In the end, we narrowed it down to three companies, and learningBOX seemed to be the most sensible to use. It also met our requirements in terms of cost. In the end, I visited Tatsuno Information System's office and met the staff, and I felt that I could do well here. I had a lot of anxiety about the process of registering and managing problems in the system, but Tatsuno Information Systems explained everything in a friendly and easy-to-understand manner, and I felt secure in their support system.
CRCs need to have trusting relationships with patients and people involved in clinical trials, so there is a lot of group training on communication at the union, but that is a very important and worrisome point. I felt that the staff at Tatsuno-san were very good at that as well.
Thank you! ...So the final decision was "people".
I think that is very important. e-learning, but when something happens, it is "people". It is very important for me to have a sense of security that I can consult with them and get the right advice.
How easy is the learningBOX to use?
LearningBOX was originally named QuizGenerator, and had a friendly and casual image of a quiz, but I feel that learningBOX has made it even easier to register questions and operate. I think it's very important for those who are thinking of introducing it to their companies to be able to use it easily and sensitively, even if they don't have an IT person in charge.
How did the price of the learningBOX compare to other companies?
I can't even compare it anymore, it was so cheap.
At the time of introduction, everyone was worried about the price. (laughs). (laughs) That's why I went all the way from Tokyo to the head office in Tatsuno City, Hyogo Prefecture, to see for myself if I could trust the company.
If it hadn't been for the learningBOX, I might not have been able to install it.
What do you want to do with e-learning in the future? Do you have any future plans?
We hope that CRCs will make use of our training and that it will help them to be confident in their clinical trial support work. This will lead to the safety and security of patients (subjects). In addition to knowledge of GCP and ALCOA, CRCs are in direct contact with patients in the medical field, and in addition to explaining and responding to clinical trials, they are also required to provide support for psychological burden. In the future, we hope to create content to improve communication and other human skills. In the future, we would like to be able to provide video streaming of group training sessions for local union companies.
This case study was introduced not only for internal use but also for inter-company use by distributing to member companies within the cooperative. Thank you very much, Mr. Shiraki, for introducing this valuable case study. We also received a lot of kind words from you, which made us feel refreshed.
Mr. Shiraki's interview was all about this mission: "Everything we do is for our patients. We are very proud and happy that our system learningBOX is a part of this "for someone else".
We will develop even more closely to our customers' needs!