Navigating Change Management in Technology Implementation: Validation, Risk, and Adoption 

Change management is the compass guiding organizations through the tumultuous waters of technological evolution, but unfortunately, it can be overlooked.  

During a recent eClinical Engage panel, “Everyone Needs Validation: Navigating and Executing the Change Management Process,” Karen Travers, Principal Consultant at Halloran, joined Venu Mallarapu, VP of Global Strategy and Operations at eClinical Solutions, and Evan Grunbaum, VP of Quality and Compliance at eClinical Solutions. They discussed industry insights and delineated the crucial aspects of validation, risk management, and organizational adaptation during technology adoption and transitions. 

In this article, we explore the panel’s insights, and move a step further to highlight current gaps and share risk-based strategies for validation. Our aim is to share these strategies with you so you too may optimize your technology and systems with a focus on change management and alignment with regulatory requirements. 

The Balancing Act of Validation 

Data validation involves a series of processes to ensure the quality and integrity of clinical data. Considering data is the product of a clinical trial, this component is crucial to clinical research success. 

One of the foremost challenges discussed during the panel was finding equilibrium in validation processes, especially between Software as a Service (SaaS) platforms and in-house processes. With SaaS platforms, balance is achieved when customers take a risk-based approach to testing data requirements. For example, sponsors should tailor each validation effort to their specific systems rather than applying a one-size-fits-all approach, so they are validating only what is inside their scope. This approach also helps to prevent duplication in validation efforts. 

Customers should also focus their testing efforts on system configuration specific to their intended use as well as any high-risk requirements regarding data integrity and regulatory requirements.  

As vendors launch new product releases, customers should also consider the impact of those changes, document their assessment, and perform any additional testing that is necessary to their configuration.  They should also assess any changes through the lens of impact to the users and address any training or communication needs as early as possible.  

Overcoming Resistance to Change: The Crucial Role of Change Management 

Resistance to adopting pre-existing standards or relying on vendors’ capabilities often stems from concerns around data integrity, regulatory alignment, and the fear of veering away from established normality. Regulatory agencies are putting significant emphasis on data security, integrity, and privacy, so staying attuned to the evolving regulatory guidance and forums is critical.  

Encouraging a risk-based approach, aligning change management strategies with technological functionalities, and emphasizing the user experience over constant upgrades aids in assuaging these objections. 

Change management, often underrated, emerged as a critical factor in successful technology integration. Advising clients to prioritize change management from the project’s inception, involving stakeholders early and often, and aligning with compliance and quality processes are key strategies.  

Moreover, linking change management directly to return on investment (ROI) metrics helps organizations stay on track with their objectives and goals. 

Crafting a Roadmap for Success 

The roadmap to successful change management lies in acknowledging the scope, managing changes effectively, aligning business processes, emphasizing user adoption, and integrating change management seamlessly into the organizational culture. 

In summary, navigating change management during technology adoption or transitions necessitates a delicate balance between adherence to regulations, user adoption, and agile validation processes. It’s not merely about implementing the technology, but ensuring the technology is absorbed, utilized, and continually evolved within the organization. 

If you’re struggling with your technology adoption or transitions, validation, and user adoption, contact Halloran.  

About Halloran’s Technology and Data Solutions 

Halloran offers cutting-edge digital innovation and data solution services paired with vast industry expertise. Halloran takes an integrated approach to define the right fit-for-purpose technology and data solutions, partnering with clients to meet their key business objectives. As a specialized consulting firm, Halloran brings a fresh perspective to propel life science organizations towards innovation, efficiency, and breakthrough discoveries.