Interactive Response Technology (IRT) Software for Clinical Trials

IT consultants work with representatives from clinical trial sponsors and CROs, including managers, trial coordinators, investigators, and site staff. Their goal is to determine the optimal feature set that can meet the research organization’s current and potential future needs.

For example, for a sponsor using IRT in clinical trials of an expensive chemotherapy drug with a limited shelf life, the main goal could be minimizing the drug's wastage. To accomplish this, the system may require advanced AI-powered supply optimization to prevent excess IP production and coordinate delivery straight from the production unit to the patient’s department shortly before the infusion is due.

If the research involves a complex study design and a large number of stratification factors, features for automatic randomization balance control may be needed. This may include real-time monitoring of the balance between patient strata, alerting researchers in case of any imbalance, and suggesting corrective actions, such as halting the recruitment of patients with certain characteristics.

Software architects carefully analyze the software requirements to design the optimal architecture for the future solution.

For interactive response technology in clinical trials, ensuring the solution's flexibility is crucial, as research organizations need to swiftly adapt the system to mid-study changes, such as protocol amendments. To accomplish this, architects often design a multi-tier architecture with a dedicated configuration component or rule engine.

This approach allows trial managers to modify the number of cohorts or visit schedules directly through the IRT interface without having to alter the software code. These changes are applied at the configuration level and propagate to all relevant workflows without causing inconsistencies. Separating the business logic layer ensures that core functionalities (e.g., randomization algorithms and drug assignment rules) continue to operate correctly despite any modifications.

UX designers plan user journeys and interfaces for different trial roles to minimize the number of clicks required to complete common tasks, thereby enhancing data entry accuracy and reducing task completion time.

For example, to make clinical trial pharmacists' work easier, the system can auto-populate fields based on previously entered data, such as patient IDs or dispensed kit details. Critical actions, such as dispensing or recording medication returns, can be prominently displayed in the front and center of the pharmacist’s workspace and designed to require the fewest number of steps to complete.

Furthermore, when registering returned empty packages and unused medication, the system may alert a pharmacist if the data does not match the amount of medications recorded as consumed in the patient's diary. Such alerts should be designed with prominent visual cues, such as color-coded notifications or pop-up messages, to immediately capture the pharmacist’s attention. They can also include interactive elements, such as drop-down options or checkboxes, for implementing quick corrective actions.

ScienceSoft usually recommends an iterative development approach to test features as they’re completed and catch issues as early as possible. Once each significant development milestone is achieved, engineers show the finished functionality to future users and ask them to provide feedback so that the team can make any necessary adjustments. For example, developers may ask researchers to generate test randomization lists and check that the workflow configuring the randomization scheme completely fits their needs.

As for the quality assurance in IRT projects, compliance and security testing get particular attention. For the system to comply with HIPAA, GDPR, FDA 21 CFR Part 11, and other relevant regulations, testers have to verify that access to trial data is limited according to the principle of least privilege (PoLP), that any data access or changes are thoroughly logged, and that controls for data completeness and integrity work properly.

It’s also important to verify the safeguards against accidental unblinding. For example, this means that IRT business logic should prevent situations where sites receive IP kits with consecutive numbers, which may indicate that they are intended for patients belonging to the same group.

After the IRT system goes live, the development team supports the research staff by providing user manuals and offering consultations. They also monitor system performance and resolve any remaining issues. For large-scale international studies, a dedicated support team and a 24/7 help desk are typically required.

ScienceSoft usually offers free software maintenance and support for the first few months after software delivery (the exact duration is dictated by the chosen post-launch warranty terms). During this time, we can either gradually transfer knowledge to your in-house IT team or assemble a team of our support agents to handle continuous software maintenance, evolution, and L1–L3 help desk.