IRT / Drug Management

Optimize drug management globally with our IRT/Drug Management solution.

Monitor drug kit status seamlessly across depots, sites, and teams in real-time. Receive automatic alerts, ensuring immediate actions are taken, and stay in control of your study drug supply effortlessly.

Drug supply, re-supply and communication between depots, sites and team are handled through the drug management tool integrated in the Study Portal. The drug management tool allows the management/tracking of the following activities:

  • Drug release by Sponsor’s Depot
  • Drug boxes receipt at site
  • Drug dispensing to patients
  • Drug (used/unused) returned to the Sponsor’s Depot for destruction
  • Drug destruction’s date by the Depot

For the first drug supply or re-supply process, the following steps are involved:

CRA Request

The Clinical Research Associate (CRA) initiates the request for the initial drug supply or re-supply. This request is often triggered by low drug availability alerts, which are closely monitored.

Depot Coordination

The request is then transmitted to the designated Depot responsible for managing the drug supply. The Depot team organizes the shipment of the required drugs.

Shipment Delivery

Once the drugs are prepared and packaged, they are shipped to the research site where the clinical trial is being conducted. The shipment is carefully tracked to ensure its timely arrival.

Drug Reallocation 

drug allocation

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.