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Post marketing surveillance (PMS) study

Case: post-marketing (PMS) study of the drug from non-clinical fatty liver disease. Data collection was carried out with the participation of 100 centers and 5000 patients for 8 months.
OnlineCRF has created an EDC system for data collection, study control, and remote monitoring.

List of activities, that managed within the EDC system OnlineCRF

Project Phase: Preparation to system set-up

Task:

Deploy an EDC system for research in 2 weeks. The Sponsor has enforced strict deadlines from the moment of approval of the CRF and the Protocol.

Our solution:

Using SOP, checklists, and compiled specifications, the data management team organized the system configuration process. Thanks to the correct organization of the process, it was possible to set up the EDC system on time.

Project Phase: System configuration

Task:

Create an opportunity for quick daily monitoring of enrolments on every 100 sites.

The Sponsor set a strict timeframe for the project, so enrolment should be done without delay.

Our solution:

A unique dashboard was created to process large-scale data and evaluate the dynamics of the study. He clearly showed the number of patients in each status in each of the centers. This helped to monitor the dynamics of enrolment daily.

Task:

Create a functionality that allows you to redistribute limits between centers for a set of subjects on time.

Our solution:

A functionality has been created that allows you to quickly change the limits for a set of patients in manual mode. Thus, if a center lagging in enrollment is found, part of its patient limit can be redistributed to centers that successfully recruit subjects.

Project Phase: Remote monitoring

Task:

In this clinical trial case study OnlineCRF team must performed remote monitoring to monitor research dynamics and simplify on-site monitoring.

Our solution:

We organized the risk-based remote monitoring procedure using the OnlineCRF system functionality. This approach allowed us to daily analyze the activity of sites and sites with high levels of risk. Information about these sites was sent to the Sponsor CSU for further on-site examination.

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