Centralized testing with unified platform and reference ranges for efficient data analysis
Mediford Corporation performs centralized testing for clinical research/trial/testing samples from nationwide medical institutions, at LSI Medience, the predecessor of our company.
This avoids differences in platforms between institutions, unifies testing methodologies and reference ranges, and facilitates data analysis of testing results.
Mediford Corporation responds to our valuable customers’ demand on globalization of drug development through our oversea laboratories network.
Central laboratory services proceeds in four stages, "contract", "initiation", "operation", and "completion".
For consultations regarding new clinical studies, mediford's sales representatives will be the first contact and manage everything from quote preparation to conclusion of contracts. When contract is signed and study is commissioned, a Project Manager is appointed for each study and performs management of the entire project until its completion.
The flow after the commission is:
We will also ship specimens to designated laboratories domestically and internationally upon request.
During the project initiation stage, specialized "Study Design Personnel"sare assigned for each study.
"Study Design Personnel" will design the entire project according to the sponsor's requests, and will configure mediford's core system, e-MADAM (e-Mediford Corporation Advanced DAta Management System), accordingly.
Study design personnel creates "Study Specification Document" (SSD) based on the contents requested by the sponsor.
In SSD, several key factors as follows are determined and described; the combination of blood collection tubes according to the tests scheduled for each visit ("visit" refer to the point at which specimens are collected from participants/subjects in clinical studies, contents/format of test requisition form/report, and specimen shipment details to designated laboratories in Japan or overseas.
Once SSD is finalized after being confirmed by sponsor, the contents will be registered in e-MADAM.
The information registered in the system includes demographics of subject (participant in clinical studies) such as gender and age, test items, visits (points for specimen collection), medical institutions conducting the study, and configuration of specimen collection material sets.
Once the system registrations are complete, projects will enter the operational stage.
Each project is performed by specialized “Study Operations Personnel” who are assigned to the project.
In the operation stage, “Study Operations Personnel” carry on every daily operational task, for instance, reporting test results to sponsor and medical institutions conducting the study, solving various inquiries (queries) related to sample pickup and its submission, internal and external coordination, and specimen shipment to overseas facilities.
When the study period ends and we receive a study termination notification from the sponsor, the project will enter the completion stage.
At the sponsor's request, mediford will archive test-related documents on contract-basis, as well as discarding or other processing of specimen stored during the study period.
