The clinical trial technology landscape is notoriously fragmented. With hundreds of potential system combinations in each trial, inefficiencies and compatibility issues abound. While vendors have attempted to address interoperability, the sheer diversity of systems limits their success.
True platform solutions may offer a path forward. Unlike fragmented tools, a well-designed platform can centralise data and provide a unified view of trial activities. However, they must genuinely support interoperability and seamless communication between systems to break silos effectively.
“By prioritising collaboration and leveraging innovative technology, the clinical trials industry can break down silos, paving the way for greater efficiency, accuracy, and success.”
Vendors must take the lead in fostering greater cooperation between systems. By prioritising user needs and creating solutions that enable smooth data flow across functions, the industry can mitigate the inefficiencies caused by fragmentation.
Adopting a task-based approach
Historically, clinical trial technologies were designed to replicate paper-based workflows rather than reimagining processes to address modern challenges. This system-centric approach creates artificial boundaries, where tasks are confined to specific technologies regardless of workflow needs.
A shift to a task-based approach is necessary to overcome these limitations. For example, randomisation tasks traditionally fall under Randomisation and Trial Supply Management (RTSM) systems. However, modern Electronic Data Capture (EDC) platforms can now handle these tasks when implemented as part of an integrated system. This flexibility demonstrates the potential of rethinking workflows to enhance efficiency and collaboration.
By focusing on workflows rather than rigid system definitions, the industry can develop technologies that better serve users. This requires a fundamental change in how solutions are designed, prioritising cross-functional usability over traditional boundaries.
The need for unified data standards
A persistent challenge in clinical trials is the lack of uniform data standards. A simple example is the numbering of clinical sites, which varies widely across systems. This lack of standardisation complicates cross-functional data integration and leads to inefficiencies.
Efforts like the Clinical Data Interchange Standards Consortium (CDISC) have made strides in breaking silos. By standardising clinical trial data, CDISC has streamlined many processes. Other initiatives like GS1’s barcode standardisation – an effort that took years to reach its first release – highlight the slow but crucial journey toward global harmonisation.
The adoption of such standards is far from universal. For the industry to move forward, a more robust and coordinated approach to developing and implementing data standards is essential. This requires not only time and effort but also a willingness among stakeholders to adopt and adhere to these standards consistently.
Toward a harmonised future
The road to breaking silos in clinical trials is long and complex. Too often, the same tasks are performed slightly differently across functions, creating discrepancies and complicating harmonisation efforts. To address this, the industry must embrace a unified approach, driven by incremental yet measurable progress.
Technology vendors have a critical role in this transformation. They can lead towards a more integrated future with solutions that bridge the gaps between functions and promote a working environment that fosters collaboration.
Achieving this will require collaboration across all stakeholders, from sponsors to regulators to technology providers. While the clinical trials industry is traditionally slow to change, focusing on achievable steps can yield significant improvements over time. A measured evolution toward better standards, interoperability, and task-based technologies will eventually lead to a data revolution, transforming how trials are conducted and managed.
By prioritising collaboration and leveraging innovative technology, the clinical trials industry can break down silos, paving the way for greater efficiency, accuracy, and success.
