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Therapeutic equivalence clinical trial

Case study of a multicenter, randomized, open-label study of therapeutic equivalence of a medicinal product for patients with knee primary osteoarthritis. Data collection was carried out with the participation of 240 patients.
OnlineCRF has created an EDC system for data collection and Prepared a statistical report.

List of activities, that managed within the EDC system OnlineCRF

Project Phase: Preparation to system set-up

Task:

Help and advice for the Sponsor in preparing the CRF for system set-up. The Sponsor took over the audit and document preparation.

Our solution:

The Sponsor's team takes care of preparing the annotated CRF for setting up the EDC system.
The OnlineCRF team held the necessary introductory consultations, and explained the features of adapting the CRF to configure OnlineCRF.

Project Phase: System configuration

Task:

Expand the functionality of the randomization module: make it possible for the doctor to add additional information during randomization.

Our solution:

We added functionality to the randomization module and created a separate randomization visit. In addition to the fact that the system automatically assigns a randomization number, we have implemented additional fields. The doctor may make notes and other important information regarding randomization in them.

Task:

Implement a report for convenient monitoring of the activity of the investigators in the EDC system.

Our solution:

We have created a custom report that collects and shows the history of user actions (in particular, the investigators). It displays the dates of significant events to monitor. For example: login date, the first patient in date, last patient in date, etc. This report helps the monitor quickly assess the dynamics of the doctor's work, identify problem areas, and work with them.

Task:

Create a complete set of supporting documentation regarding the EDC system. The documentation should confirm the configuration and verification of the system, as well as compliance with international standards.

Our solution:

The turnkey system set-up process was carried out according to industry standards and guided by internal processes and SOPs. After configuration, the customer received a ready-to-go EDC system, with a full set of the necessary documentation.

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