We cooperate with a big American EDC vendor DATATRAK and construct, manage and clean up an EDC environment for clinical trials in Japan. DATATRAK ONE has already been use at over 1,000 clinical trials in the world. It has the reputation of being easy to use, easy to develop and cutting the cost drastically. In this system’s case, all of necessary functions for clinical EDC systems are in one platform and one user interface. Therefore, it always earns the reputation. When you use other EDC systems, a manager needs to consider linking randomization and coding with other tools every day. However, DATATRAK ONE doesn’t make you do it. Experience the drastic cost-cutting and efficient clinical trials with DATATRAK ONE.
DATATRAK ONE Suite体系
Since DATATRAK ONE®UX CTMS™ visualizes a clinical trial from the beginning to the end, you can have a fine-tuned trial. Therefore, it lets you manage the balance between the fluctuation of trial cost and budget. Here is what UX CTMS can do:
- Supporting decision-making
- Grasping the state of financial affair
- Grasping and solving issues
- Managing traceability etc
UX Trial Design™
UX Trial Design lets you construct a whole plan to a process of development with a single tool. EDC system construction designer can construct clinical trials with multiple Suites of DATATRAK ONE. You can check a screen that you make through Web. Even if mid-study change happens after a trial starts, modifications are set in the environment without suspending the system.
UX EDC & Medical Coding™
UX EDC and UX Medical Coding are very user-friendly and they offer high-quality clinical data. They deal with special needs of data at each trial. Furthermore, they grasp states of each trial closely with personalized dashboard report. You can deal with an edit check at a web screen before saving the data, so you can cut the amount of query drastically. They are exactly the modules that improve the quality of your data.
UX Safety integrates individual case safety report (ICSR) and reduces operations for reconciliation. It collects, integrate and manage your patients’ safety data, so you can simplify making SAE report. Moreover, it lets you access and trace all clinical and safety data that you need to submit at a single environment. Here are the advantages of UX Safety:
- Managing individual case safety report: The application collects and manages ICSR data that is a standard in the industry.
- Transforming and abstracting E2B format: You can cut the operations for data entry and reconciliation through the function that transforms data collected by UX EDC & Medical Coging and abstracts them. In addition, E2B data can be uploaded into other safety systems.
- Creating regulation form: It creates medwatch and CIOMS form that are required at application for approval. An input field is automatically prepared based on adverse event data.
- Making ad-hoc-report and abstracting data: You can easily make a report and abstract data with ad-hoc-report making engine.
UX Randomization & Trial Supply Management™
UX Randomization & Trial Supply Management (RTSM) supports randomization and supply of medicine at trials with different protocols. RTSM manages user view on demand, distribution of medicines and their containers, renewal of schedule for shipping and randomization and information of exportation.
- Simple and powerful randomization: You can check if randomizations for patients are carried out as scheduled on the system on real time. The powerful and minimized algorithm optimizes registration.
- Automating distribution and inventory control of medicines: It automatically arranges medicine for randomization. The inventory control tool controls automatic supply events that manage e-mail notifications and shipping and management.
- Designing application testing: You can manage supply of medicines and shipment rules easily.
- Making a trial blind and unblended: You can control visualization of stock of medicines and randomized events.
UX Training manages many kinds of trainings at the environment based on GCP. It manages not only basic training course on Web by DATATRAK but also training courses that your study team creates. Any course can be carried out through the training management system by DATATRAK. Therefore, you can carry out training at a seamless environment. Here are advantages of UX Training:
- You can construct training module of a proper protocol.
- You can save a state of training and manage its history.
- You can upload a training module of the third party.
- You can save documents related to the clinical trials and manage their history.
- It has the automatic access function for a trial after training. Etc.