Embracing Change: The Crucial Role of Change Management in Adopting AI-Driven SaaS Technology in Clinical Development

While SaaS technologies have been integral to clinical development processes, their adoption continues to pose challenges across Pharma and Biotech companies. As these technologies evolve—particularly with AI as a transformative force—the challenges become even more amplified. AI-powered SaaS platforms offer clinical development teams unprecedented opportunities to optimize protocol design, enhance decision-making with actionable insights, and improve trial efficiency. However, adopting these advanced tools goes beyond selecting the right technology; it’s about successfully integrating them into workflows in a way that empowers teams to fully leverage their capabilities. This is where effective and structured change management comes into play. It ensures successful adoption of the technology by guiding stakeholders from their current ways of working to more optimized processes. This approach isn’t just about technology; it’s about creating an environment where the technology can drive meaningful change in clinical development and, ultimately, accelerate and improve the delivery of treatments to patients.

The Role of Change Management in SaaS Adoption

Across Pharmaceutical R&D and Biotechs, change management has always been crucial in embedding new processes or methodologies into the fabric of daily operations. In the context of adopting advanced SaaS technologies, particularly within the highly regulated environment of clinical development, change management is evermore critical. Beyond software deployment, it involves ensuring that end users and impacted stakeholders are not only equipped with the necessary skills to utilize the new technology but are also fully engaged and motivated to embrace it. Effective change management addresses the holistic aspects of this transition—overcoming resistance, fostering a culture of innovation, and aligning new technologies with existing workflows to enhance overall efficiency. It’s about creating an environment where the adoption of sophisticated SaaS tools is seamless, and their benefits are fully realized across the organization.

In the highly scientific and technical-expertise-driven realm of clinical protocol design and development, the stakes for successful change management are particularly high. This process involves collaboration across multiple stakeholders, including clinical scientists, medical writers, data scientists, clinical operations and regulatory affairs teams each contributing their specialized knowledge and expertise. Protocol design has traditionally been a very manual process, characterized by extensive handling of unstructured data and intricate decision-making. While the introduction of Study Designer tools offer opportunities for optimization, they also bring challenges in building stakeholder trust. Change management must be nuanced, the tools are introduced carefully and with a deep understanding of the complexity of protocol design. The goal is to demonstrate that these technologies enhance reliability and outcomes, rather than causing disruption. 

At Faro, we understand that successful change management in adopting AI-driven tools requires a thoughtful approach based on the fundamental pillars of people, process, technology, culture, and continuous improvement. People are at the heart of this transformation, encompassing everything from training end-users to equipping leaders and stakeholders with mission-focused strategies that ensure alignment and commitment. Processes are reviewed to identify opportunities for adaptation that not only integrate the product seamlessly but also optimize existing workflows, streamlining ways of working and driving operational efficiency. We work with teams to ensure that process optimization enhances both the integration of our Study Designer, and the consistency of daily operations, without causing unnecessary disturbance. And finally, the technology itself is at the core of what Faro delivers. However, we recognize that even the most powerful technology must be supported by ready people and optimized processes. By ensuring teams and workflows are fully prepared, the integration of Faro’s Study Designer can be seamless and effective. Culture and continuous improvement round out this framework, fostering long-term engagement, adaptability, and a commitment to refining the process as teams grow more comfortable with the technology over time.

Key Components of Faro’s Change Management and User Activation Approach

At Faro, our approach is designed to empower Study Designer users to achieve value quickly and efficiently while maximizing ROI. By addressing high-level business objectives while empowering clinical teams, we ensure that our Study Designer not only aligns with R&D business goals but also drives meaningful, practical changes at the operational level. Using our technology and services, we work with our customers to:

  1. Analyze and understand their current state
  2. Map the protocol development process
  3. Create a value realization structure
  4. Map and actively engage cross-functional stakeholders 
  5. Activate users quickly

We collaborate with leadership to understand the key initiatives such as reducing site complexity to become a preferred sponsor, minimizing patient burden to improve recruitment or ensuring that protocol data acts as the source of truth for downstream integrations. These strategic objectives inform how our platform is used to streamline protocol development and deliver measurable improvements across clinical trials.

Simultaneously, we work closely with Therapeutic Area (TAs) and study teams to create customized benchmarks, KPIs, and performance metrics that align with these top-level goals. This empowers the teams executing the work to own and drive the changes, ensuring that protocol development is consistently optimized for efficiency and effectiveness.

By integrating these strategies,, our change management and user activation approach ensures that:

  • Leadership objectives are met through protocol optimization, leading to faster, more efficient trials that maximize ROI.
  • Therapeutic Area teams are empowered to align their KPIs and metrics with organizational goals, driving deeper adoption and engagement with the platform.
  • Cross-functional collaboration is enhanced, as protocols become a data-driven source of truth, facilitating decision making and streamlining downstream clinical processes. 

Working with Faro Health to adopt Study Designer

As a leading provider of data-driven solutions for clinical protocol design, we understand that successful adoption goes beyond the technology itself – it’s about empowering end users and stakeholders for enterprise-wide impact. We work closely with your teams to build frameworks that ensure smooth transitions and transformation, so you can fully realize the benefits of innovation, efficiency, and improved outcomes in clinical development. To see how Faro can transform protocol design for your teams, contact our team for a demo or to learn more.