Test results from the central laboratory service are aggregated into mediford's core system (e-MADAM: e-Mediford Corporation Advanced Data Management System).

The test results at each testing department are transmitted to e-MADAM and they are combined with information (referred to as "demographic information") of each identical participant/patient in the study. "Demographic information" includes gender, age, collection date and time of sample, and whether or not the patient is fasting. Thereafter, along with demographic information, the test results are reported to the sponsor and the medical institution conducting the study, by desired forms.
Three types of reporting methods are available: "Web browsing system (e-MADAM plus)", "test report" (hard copy/fax), and "Electronic data".

Test results can be viewed on the web test data browsing system (service name is "e-MADAM plus").
The status of sample submission, test results, test value alarms, etc. for each participant (or subject/patient) in clinical studies by medical institutions can be viewed on the web. Alarm details will be notified via e-mail, as well.
We also provide electronic data to client's data management department, after consulting regarding the format.

"e-MADAM plus" is a system to view information entered into mediford's core system (e-MADAM: e-Mediford Corporation Advanced Data Management System) using a web browser.
User accounts are issued for all users. Registered users with accounts can browse the site and the accessibility is controlled by users. Registration for the user account can be applied via e-mail.

Two types of service contents

e-MADAM plus provides "basic services" and "optional services".

Basic services

"Basic services" include subject lists, display of details for each subject, download of test reports, notification of critical value alert (alert function in case of data outside reference intervals or abnormal values), etc.

Optional services

As "optional services", it is possible to provide alarm notifications for test values specified by sponsor, progress alarm notifications, graphical display, results list by testing item, progress status for individual subject in studies, etc.

Security measures

For the first log in, you can log in with your user ID and initial password.
When the services are used, a user is required to enter an encryption key issued for each clinical study, and the access will be limited to only users involved in the study.
It is also possible to control accessibility by users. If settings on accessibility need to be changed, you can apply them through the webpage after the study starts.

Test report

Test reports are posted in PDF format on e-MADAM plus. This PDF can be downloaded as needed if you have a user account.

Information viewable

Screening View

In the "Screening View", the progress status of all subjects is displayed in a single list. Contents can be sorted by displayed item.

Test results list

In the "Test results list", test results of all visits for the selected subject are displayed in a list. It is possible to make arrangements such as changing the background color display according to testing schedule, showing results graphically, and calculating variation rate.

Test value alarm

In the "Test value alarm" section, detailed settings for reporting test results are available.
For instance, it is possible to set multiple judging stages in advance by testing items, or to set judgment point based on variation rate from the preset test value at a certain visit as a criteria, and those notifications can be sent, as well.
It is also possible to set notifications with conditions that specific comments are added to the test results, or that multiple judgment conditions are satisfied.

Progress Alarm

In the “Progress Alarm” screen, scheduled visit dates in future are calculated and shown beginning at sample collection date designated as the base line measurement.
An alarm notification is sent when the sample was not submitted on the scheduled visit date, or allowance for the visit schedule can be set in advance as well.
In case of situations requiring an alarm, a notification will be sent via e-mail.

In addition to reporting via web browsing system (e-MADAM plus) as a standard service, clients can also select receiving reports by hardcopy or fax as an option. "Test report" will be delivered via either media of hardcopy or fax.
The contents of the report and the method of description are defined in consultation with client during the initiation stage of each study, and described in "Study Specification Document (SSD)".

When there are modification in subject's demographic information or test items, etc., a revised test report with revision history will be issued.
The changes will be displayed in red font in the revised report, and the information before and after corrections will be listed in the "Summary of changes" column by each report date.

At Mediford Corporation, data included in test reports reported from our core system e-MADAM is stored in the electronic data output function (DsDL: Dataset DownLoad). Clinical testing results preserved as laboratory data can be provided as electronic data to clients.
Electronic data is primarily provided to the data management department of clients and is used for statistical analysis and approval applications to the pharmaceutical regulatory authorities.
Laboratory data specialists at mediford are the clients’ point of contact and support data management operations and provide high-quality services for every study consistently from initiation, operation stage to its completion.

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