SOCAR's e-Clinical solution

e-STUDYM - electronic Study Management

    The e-STUDYM functionality enables access to, and an optimal utilisation of, clinical and operational metadata between members of the research project's multidisciplinary team. These facilities are essential to ensure an effective communication flow between all stakeholders, thus assuring a timely set-up and completion of the study with highest possible data quality. In addition, real-time, quality reporting facilitates effective decision making.

Sponsors have permanent access to up-to-date study metrics ensuring full transparency at all times. The detail and content of the listings and reports are customisable for each research project.

For site users, the research project can be managed and organised in a more efficient manner. For both the patient and site users, this tool facilitates the planning of the subsequent visits and enhances compliance with follow-up. Site personnel also have continuous access to a task list which details study-related activities for their site such as visits which should be completed or signed, and e-DCFs requiring resolution.

The clinical data and study management teams have real-time access to clinical and operational metadata within the same application. The teams are continuously informed of the study status and can identify early problems as they occur. This dynamic approach to study management optimises workflow and the proactive implementation of solutions to identified issues. This means that full control is achieved on an ongoing and systematic basis.

The organisation of the workload for Clinical Research Associates (CRA) is streamlined and simplified as the planning of the site visits, management of the on-site visit reports, tracking of the source data verification (SDV) performed and all site management related activities can be tracked within the same system. Once uploaded in the system, the on-site visit reports can be accessed by authorised users on 24/7.

Key features and benefits of e-STUDYM are:

Patient data and study information collected and stored within the same application
Allows for an improved communication flow between the multidisciplinary project research team
Organisation of workflow optimised by the use of pre-defined task lists and proactive communication
Online controlled access to study documentation (e.g. study protocol, newsletters...)
Continuous access to training support
User restricted access to flexible, up-to-date study status reports and performance metrics
Allows for early detection of 'problems' at a site level or for the overall research project
Facilitates the planning and organisation of on-site visits and enables the electronic tracking of all contacts with the sites
Electronic management of site visit reports with continuous access to the uploaded reports for authorised users
Electronic tracking of the Source Data Verification (SDV)


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