In this engaging interview with Jennifer Duff, General Manager, Zelta Clinical Trials Solutions at Merative, we explore technology’s pivotal role in clinical research, particularly the challenges and solutions around integrating new systems into clinical trials. Jennifer discusses common pitfalls such as inadequate change management and the superficial adoption of new technologies without assessing their necessity or impact. She also sheds light on strategies that Zelta, Merative’s core product for the clinical trial tech space, uses to align technology with the specific needs of each study, enhancing efficiency and effectiveness in clinical trials. Additionally, the discussion touches on the transformative potential of decentralized clinical trials and advancements in AI and machine learning, highlighting Zelta’s leadership in navigating the evolving technological landscape in clinical research.

Moe: What are CROs’ common technological pitfalls, and how can these be mitigated?

Jennifer Duff: One of the most common pitfalls CROs face is the challenge of inadequate change management when new technologies are introduced into the clinical trial process. Often, the focus is narrowly placed on the technological upgrade itself without considering the broader implications on people and processes. This oversight can lead to disruptions, as staff may not be adequately trained to leverage the new tools or existing processes may not align with the new systems, resulting in inefficiencies and potential data integrity issues. At Zelta, we address this challenge by adopting a holistic approach that balances technology integration with comprehensive training programs and process re-engineering. This ensures that everyone involved—from clinical trial managers to data analysts—is fully equipped to use the new technologies effectively and that the processes are optimized to take full advantage of these technologies’ capabilities.

Additionally, Zelta implements a continuous feedback loop during and after deploying new technologies. This approach allows us to gather insights directly from the users at all stages, including the sites & patients, identifying areas where additional support or adjustments may be necessary. We also strongly emphasize scalability and flexibility, ensuring the technology can adapt to evolving trial needs and regulatory changes without requiring complete overhauls. By focusing on these aspects, we help CROs avoid common pitfalls such as data silos and compliance risks, ultimately leading to smoother operations and enhanced trial outcomes.

Moe: In what ways do sponsors commonly misstep in their technological approaches, and how does Zelta address these issues?

Jennifer Duff: Sponsors frequently gravitate towards adopting the latest technological innovations, drawn by their novelty and the promise of enhanced capabilities. However, this approach can lead to significant missteps when these new technologies are not thoroughly evaluated for their necessity or suitability for ongoing or planned clinical trials. Such misalignments can result in wasted resources, increased costs, and extended timelines that do not necessarily improve trial outcomes. In many cases, existing technologies or systems familiar to site staff and participants might be more effective, particularly if they are well integrated into current workflows.

Jennifer Duff General Manager Zelta Clinical Trials Solutions at Merative

To address these issues, Zelta works closely with sponsors to align technological tools with each study’s specific objectives and regulatory requirements. Before recommending new technologies, we explore whether enhancing or optimizing existing systems could meet the project’s needs. This method conserves resources and reduces the learning curve and potential resistance from clinical trial teams and participants who may be more comfortable with familiar systems.

Moe: How are technological strategies evolving in response to the increasing complexity of clinical trials?

Jennifer Duff: The need for advanced technological strategies becomes apparent as clinical trials grow in complexity, involving more diverse patient populations and intricate protocols. The shift away from one-size-fits-all solutions is driven by the realization that different trials have unique requirements that a universal solution cannot adequately address. Instead, we are embracing a model that resembles the integrated technology ecosystems found in other industries. For instance, just as individuals use interconnected apps and devices for daily tasks, clinical trials are beginning to utilize interconnected technological tools to manage various aspects of the trial process.

This ecosystem approach facilitates better engagement and interaction with trial participants. By employing technologies that participants are already familiar with, such as mobile apps and wearable devices, we can enhance user experience and improve the quality of data collected. These technologies also support real-time data collection and analysis, which is critical for adapting to issues arising during the trial, and integrating these technologies into a cohesive system ensures that we can meet the dual demands of regulatory compliance and operational efficiency, ultimately leading to faster, more reliable trial outcomes.

Moe: What role does technology play in reducing the burden on participants and improving data collection in modern clinical trials?

Jennifer Duff: Technology is crucial in reducing the burden on participants by creating more user-centric clinical trial processes. We aim to integrate the technology seamlessly into participants’ lives, much like smartphones have become central to everyday activities. For example, using mobile apps for remote monitoring and electronic data capture, participants can engage in clinical trials from their homes without needing frequent site visits. This reduces travel and waiting times and enhances the inclusivity and accessibility of trials for people from varied geographical and socio-economic backgrounds.

By employing advanced data analytics and machine learning, we can optimize trial execution and streamline data collection processes, thus minimizing the necessary interventions or assessments participants undergo. For sites and sponsors, technology such as centralized data platforms and automated compliance tracking tools significantly cut down administrative overhead and improve the accuracy of data collection, reducing errors and the need for data reconciliation. The strategic use of technology in clinical trials by Zelta aims to enhance participant experience and improve operational efficiency, making clinical trials less of an imposition on participants’ lives while enhancing the quality and reliability of the collected data.

Moe: Can you discuss the impact of decentralized clinical trials (DCTs) and how Zelta clinical trial technology enhances their operation?

Jennifer Duff: Decentralized clinical trials (DCTs) are transforming the landscape of clinical research by enabling the conduct of trials with increased flexibility and participant-centric approaches. These models reduce the need for participants to frequently visit trial sites, which can be particularly beneficial for those living in remote areas or with mobility challenges. With the Zelta platform, we leverage electronic consent (eConsent) technologies and digital platforms for patient-reported outcomes to enhance participant engagement and streamline data collection. Our eConsent technology simplifies obtaining and managing consent, ensuring that participants fully understand the trial requirements and their rights without the logistical barriers of in-person meetings. Similarly, by using apps to collect patient-reported outcomes, we can gather more timely and accurate data directly from participants, enhancing the quality of the data and the overall efficiency of the trial.

Zelta is also committed to improving DCT operations, which extends to our robust data integration systems that support a seamless flow of information across various trial components. Our flexible, app-based solutions are designed to integrate effortlessly with existing healthcare systems and can be customized to meet the unique needs of each trial. This adaptability is crucial for hybrid trials, where components of traditional and decentralized methodologies must be combined effectively; for example, enabling seamless flow of data from EHR/EMR systems used for in-home visits or direct data capture. Ultimately, this technology supports the operational aspects of DCTs and significantly enhances the experience for all stakeholders, leading to higher engagement rates and more successful trial outcomes.

Moe: What advancements in AI and ML influence clinical trials, and how is Zelta positioned to lead these innovations?

Jennifer Duff: The advancements in artificial intelligence (AI) and machine learning (ML) are set to transform clinical trials by improving the speed and accuracy of various processes critical to successful outcomes and the ability to process significant amounts of data. Specifically, AI and ML are revolutionizing patient selection, predictive analytics, and real-time data monitoring. For instance, AI algorithms can analyze vast datasets to identify suitable trial candidates more quickly and accurately than traditional methods, potentially reducing the recruitment period and increasing the diversity of participants. In medical coding and data management workflows, ML models are trained to automatically categorize and process clinical data, reducing human errors and the administrative burden on clinical staff.

Zelta is strategically positioned to leverage these AI and ML advancements to their fullest potential. We focus on integrating these technologies into our core systems, ensuring that they align with and enhance the structured framework of clinical trials. By focusing on key applications where AI and ML can deliver measurable benefits, such as improving data accuracy and operational efficiency, we ensure that our technology investments translate into tangible value for our clients. For example, our AI-driven platforms are designed to adapt to the changing dynamics of trial data, providing continuous learning and improvement opportunities. This capability allows our systems to support current trials and evolve with advancements in the field, ensuring that Zelta remains at the forefront of technological innovation in clinical trials.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.