MiTOX is a safety study system to achieve major cost cutting and streaming while operations of data control and practice and electronic submission compliant to GLP*, FDA 21CFR Part11 and MHLW ER/ES*. It also manages whole procedures in pre-clinical studies from planning, performance, recording and reporting. It also has a function to manage overall of both hardware and software, so that it implements efficiency of comprehensive operation and improvement in data quality in researches.
Performances of studies compliant to GLP are achieved. Quality, completed and total of data are assured by managing whole procedures in studies from planning, performance, recording and reporting. In addition, it enables strict system operations of systems as operation procedures is defined which meet the researchers certificates.
Information of whole procedures in safety studies from planning, performance, recording and reporting are consolidated in server in real time. Enormous data from each operation room are effectively managed and controlled.
As operation items to be performed on the day are commanded on the screen, operations become simplified at the laboratory. As the screen is designed for anyone to input easily, it brings prevention of erroneous operations and efficiency of work. As the study schedules can be freely set, it can be used for exploratory studies.
It makes a significant contribution of speeding up to research operations by significant reduction of needless existing operation flow and standardizing and automation of study procedures.
By any possibility of disaster, it has formulated thoroughgoing safety measures for hardware, database and applications.
MiTOX has a function to perform safety studies in which FDA 21CFR Part11 and MHLW ER/ES guidelines are necessary as regulatory requirements for electronic records and signatures.
MSR had released the first edition of MiTOX (Safety study system) at the same time as the enforcement of GLP in 1983. And later, MiTOX has been introduced and utilized in many companies (pharmaceutical companies, CRO, etc.). Achievements of MITOX introduction in Japan are 41 companies (88 systems) as of January 2014.
MiTOX focus on the following.
・Increase productivity, improve the quality of study
・Statistical analysis by SAS
・Assurance of data integrity and quality
・Many achievements of system introduction and data submission
・Flexibility of the system
・MITOX meets the user requirements
・Fully compliant with GLP
・Real-time online processing
・Compliance with 21 CFR Part11
・Compliance with MHLW ER/ES
・Possible to export the leaf file of eCTD*
・Possible to export the dataset in accordance with CDISC SEND IG 3.0*
Ministry ordinance: Nonclinical safety studies that are used to support the development of a pharmaceutical should be conducted in accordance with Good Laboratory Practices.
(*FDA 21 CFR Part 11)
U.S.C.: Electronic Records, Electronic Signatures
ER/ES: Guideline for the use of electromagnetic records and/or electronic signatures in applications, etc. for authorization or permission regarding pharmaceuticals and other items.
Electronic Common Technical Document
Clinical Data Interchange Standards Consortium
Standard for Exchange of Nonclinical Data implementation Guide for Animal