Accelerating study start-up through standardised IRT integration

For sponsors running global, multi-site studies, IRT integration delays can jeopardise timelines and data integrity.

This case study highlights how a large sponsor reduced integration development time by 80%, accelerating study start-up and cutting costs through the standardisation of IRT integration across programmes.

Fragmented integration practices were costing time, money, and quality. The absence of a standardised approach led to recurring issues:

• Redundant development efforts and duplicated work across studies and teams
• Inconsistent data mapping, increasing the risk of miscommunication
• Limited reusability and scalability of integration components
• Higher risk of data errors, audit findings, and potential compliance gaps

To overcome these hurdles, we developed and implemented a structured, five-phase approach designed to streamline integration efforts and drive consistency:

1. Auditing existing integrations: We conducted a comprehensive audit of existing integrations to identify recurring patterns, redundancies, and pain points.
2. Aligning cross-functional teams: Collaborating with the sponsor, project managers, technical leads, and developers, we captured cross-functional requirements and aligned on strategic integration goals.
3. Defining integration standards: We defined key parameters to guide future
   integrations:
   1. File types, delivery methods and transfer frequency
   2. Naming conventions, required data points, and error-handling protocols
   3. Preferred integration platforms to streamline development and support
4. Building governance and knowledge sharing: To embed consistency and enable knowledge sharing, we created a centralised knowledge base including standardised templates, process guidelines, and integration best practices.
5. Testing and validating the framework: We applied the framework to a high-impact integration project, gathering real-world feedback to refine the standards and validate its effectiveness before broader rollout.

The new integration framework streamlined the processes and delivered tangible value.

• 80% faster integration development, freeing teams to focus on value-add activities
• Significant cost savings through reusable components and reduced rework
• Improved data accuracy and stronger audit readiness
• Faster study start-up, enabling quicker patient enrolment and trial execution

With a scalable, standardised integration model in place, the sponsor is now positioned to deliver faster, more cost-efficient trials, without compromising quality.