Gravity EDC (Electronic Data Capture)

EDC

Outline

We provide all functions as EDC (Electronic Data Capture) that complies with ER/ES guidelines. The development period is short and we can offer it at a low price.
This system can automatically generate a screen from a protocol (trial protocol) and CRF, and quickly responds to trial patterns of any pattern (currently under development, scheduled to be released by the end of 2020).

 

Not only for clinical research, but also for clinical trials and PMS.

New Concept

EDC is in a new era.
Various negotiations for construction, frequent revisions of specifications, complicated tests, and specification changes after implementation. Building an EDC has taken time and effort. Our new Gravity EDC frees you from any effort.

Contents

The main functions are as follows.

Category Details
Access and Authorisation Number of users and roles can be created without any limit
CRF Input You can configure any pattern of CRF (data entry screen). You can set a logical check without any upper limit to the input items.
CRF can be output as PDF at any time.
Randomization Randomization is provided as a standard feature
DM Function Query (automatic, manual) issue management, audit trail, and form output are possible.
Digital signature Digital signature is a standard feature. Personal certificates can also be issued.
Medical Coding It is possible to code adverse events in MedDRA and to code drugs using a drug dictionary.
Data import/Export Data can be output at any time and external data (clinical test values, images) can be imported.
Progress management You can check the progress of the test in real time on a list, form and dashboard.
Monitoring You can grasp the progress of the facility in real time and create a monitoring report in conjunction with the EDC data.
SDV SDV records (reports) can be saved.
ePRO ePRO is provided as a standard feature
GVP compatible It is possible to report/manage safety information, confirm opening of report data, output disease reports (authority format), and transmit E2B data.
CDISC compliant A database structure and output conforming to the CDISC standard are possible.
Automatic CRF Generation The eCRF screen can be automatically generated from the research implementation plan.
Responsive design It can be used not only on PC but also on smartphones and tablets.

CTMS

CTMS (Clinical Trial Management System) realizes automation, efficiency, and visualization of all processes for managing the progress of clinical trials. By linking with EDC used in clinical trials in operation, you can grasp the progress in real time on the dashboard..

Monitoring

The Monitoring System supports monitoring operations in clinical trials. We respond to the needs of on-site monitoring, central monitoring, and risk-based monitoring (RBM).

Products to be launched in the future (AI)

We are developing a new tool that will automatically build the EDC. The required items are automatically extracted from the protocol of clinical study to create an EDC. All processes for setting up EDC are automated, significantly reducing costs and labor. It will be available in March 2021.

For further details Contact Us


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