Online Randomization / IWRS

Facilitate random participant allocation with our Online Randomization/IWRS solution.

Enable the random assignment of numbers and allocation to specific treatments, ensuring participants are grouped for various treatments by chance. Streamline your allocation process ensuring fair and unbiased distribution for diverse and comprehensive study results.

OPIS employs an advanced Randomization module that seamlessly integrates with the Electronic Data Capture (EDC) platform to manage patient randomization in clinical trials. OPIS utilizes IWRS (Interactive Web Response System) integrated into the EDC platform to facilitate patient randomization.

This integration streamlines the randomization process and ensures accuracy. Interactive Response Technology (IRT) is an umbrella term that refers to both Interactive Voice Response Systems (IVRS) and Interactive Web Response Systems (IWRS).

The Randomization module allows for the assignment of a randomization number and/or the allocation to a specific treatment arm. This crucial step ensures that participants are assigned to different groups receiving various treatments or interventions by chance.

The entire randomization process is fully integrated into the eCRF (Electronic Case Report Form). Investigators can activate the randomization procedure directly from the eCRF page. This integration provides immediate access to essential information, including the randomization number, treatment arm designation, or the specific drug kit to be dispensed.

OPIS’s Randomization module offers a seamless and efficient solution for the random assignment of participants in clinical trials, enhancing the integrity and rigor of the study’s design and execution.

Learn more about our Modules!

Medical Monitoring

Ensures patient safety, data integrity and provides medical expertise and oversight for the clinical trial, from initial study design through final clinical study report release.

Protocol Deviation Tool

Designed to minimize risks, ensure strict adherence to study requirements and timelines, and safeguard trial integrity by swiftly identifying and addressing deviations or issues.

IRT / Drug Management

Enables to have real-time information about drug supply at the sites, issuing automatic alerts to inform users and vendors about the immediate actions required.

Online Randomisation / IWRS

Allows casual assignment a specific treatment, ensuring that participants are assigned to different groups receiving various treatments by chance.

Import from External Sources

It facilitates the import of data into the study database and allows for export in various formats such as XLS, CSV, thereby simplifying data management for the team and providing convenient access to individual study participants.

eLearning

Enables tailored training for all investigators participating in a clinical trial, not only for the trial protocol but also for the use of the system itself.

eSAE

Allows investigators to access all safety information in a single container. Expedites the procedures for sending, reporting events, with a highly adaptable solution for SAE or pregnancy notification reporting.

ePRO

Enables to make the trial more subject-friendly, limiting visits to the hospital & clinic creating a direct connection between the subject and the study staff that is easy to access.

Images Tool

Permits to capture a complete view of patient well-being through our comprehensive archiving system, accommodating everything from daily smartwatch snapshots to intricate images like X-rays and CT scans.

Architect Module

Empowers customers to tailor their tool to their specific needs while relying on OPIS Staff for more technically complex aspects of the clinical trial process.

Patient Allocation Tool

Manages the pre-allocation of subjects who could be enrolled in different trial phases, matching patients to the most cost-effective level of care and the most clinically appropriate one.

Dosage Calculation Tool

Strictly related to the patient allocation in a study, allowing the Sponsor to modify dose assignments and the users to kept update via email notifications.

Cell & Gene Therapy Modules

Cell and gene therapy (CGT) is an innovative approach to treating various diseases by harnessing the power of cells and genes to address underlying genetic or cellular defects.