Increase Efficiencies through Effective IRT Partnering

Challenges

Perceptive was asked to come up with a solution that would alleviate the RTSM-related pressures on the study team, freeing them to focus on other critical development needs. The challenges put forward for the RTSM technology were:

• Create repeatability in the design and delivery of the Interactive Response Technology (IRT)
• Streamline processes such as communication channels and study requirements documentation
• Create efficiencies for sites and in the delivery of each study’s IRT implementation
• Quickly implement protocol amendments to address the lag time of regulatory response

The expectation was that when these key areas were addressed, the biotechnology company would have the agility and flexibility needed to conduct their trials with confidence, ensuring continued support and growth of their portfolio. Naturally, this had to be accomplished without introducing risk or loss of data quality and accuracy.

Additional expected outcomes included the ability to:

• Ensure true alignment between IRT delivery and study teams
• Increase access and visibility into patient and supply chain data
• Leverage automation as part of the solution
• Increase efficiency in end-to-end IRT delivery

Reduce if not eliminate:

• Time needed to gather, document, and review requirements
• Need for custom programming
• Time required for User Acceptance Testing

Solution

The IRT system Perceptive implemented was a business solution, encompassing both technology and service and ensuring that the people, technology, and processes were agreed upon by both organizations. The technology part of the solution included the development of IRT standards as well as the supporting business processes. It also required some processes to be adapted or new ones created.

Standards

Developing IRT standards was a collaborative process, which ensured the standards covered the three typical levels of functionalities in the IRT system:

• Core standards
• Sponsor standards
• Protocol requirements

Typical functionalities of Perceptive’s core IRT standards address such items as randomization algorithms, inventory management functionalities and algorithms, drug accountability workflows, and integrations. As a result, Perceptive standards come with inherent system flexibility and adaptability to align each IRT deployment to the study protocol without the need for custom programming.

Sponsor-level standards encompassed their commonly used functionalities or settings, such as countries, depots, and inventory management preferences, all linked to their existing processes.

Process-related items included how project communication or standards adaptation would be handled, the communication channel, forms, templates, and other standard documentation such as project agreements, unblinding addendums, and project requirements form. They also included site-level processes identifying how site users were to interact with and utilize the system. This drove some of the biotechnology company’s specific user access requirements and standards development through reporting accessibility and useability.