Guest blog by Lisa Cooney, Director, Operations Transformation – Life Sciences, Grant Thornton LLP

If there’s one issue that unites all businesses as they improve processes, embark on next waves of digital transformation, or replace/upgrade their software, it’s the challenge of user acceptance and adoption.

Understanding change management best practices can make all the difference between success and failure of your software investment. And nowhere more so than in life sciences Regulatory operations. The growing complexity of health authority regulations, increasing submission workloads, and pressure to modernize technology creates a dynamic environment where Regulatory teams need to make the most of their transformations.

So why is it that Regulatory functions, in particular, can prove so tricky to engage in system replacements and enhancements – and how can teams overcome those barriers as they look to bring practices more digitally up to date?

Understanding Regulatory reasoning

One of the first rules of effective change management is to understand the unique characteristics of each user group, so their perspectives, needs, and concerns are considered and cared for.

Typically, Regulatory leaders have grown up within that discipline, rather than being promoted from a non-Regulatory function. These leaders bring with them a love of detail and rigor that is critical to regulatory compliance. They often need to see complete details about the change before they’re willing to show their support.

Regulatory teams in particular value early pilots, and the chance to see software in action applied to their own data – rather than a generic demo. For instance, if clearer and more dynamic reporting is a powerful new capability with a new system, it’s useful if they can see what that would look like in the context of their own roles and work.

Regulatory teams also thrive in focus group settings, where they have the opportunity to ask detailed questions, and provide real-time feedback. These change tactics, while advisable for any team, are especially relevant to Regulatory colleagues.

Including users from the outset

A common reason for poor user buy-in in any system replacement or process transformation is that the sponsoring teams have considered or embarked on change management too late.

Too often viewed as ‘a bit of training to support the final transition’, change management’s impact is minimized when you skip critical steps like creating awareness of the change and engaging stakeholders in the transformation journey. Companies who assume user buy-in are usually disappointed by the results.

In these highly collaborative, digitally-enabled times, all of the channels and tools exist to bring users along on the journey. But, we also need to make a deliberate choice to engage and communicate with users early in the project. Rather than slowing us down, this collaboration takes the solution farther and creates better outcomes.

Offering experiences that feel familiar

Getting users to feel comfortable with a new system can also be a barrier to adoption. The shift from point solutions to end-to-end, plug-and-play platforms is a huge game-changer in this regard – the chance to plug in the latest RIM or Quality management functionality into an existing platform with a familiar user experience significantly reduces the user’s burden to learn something new. Gone are the days when each department needs to start from scratch each time new functionality is added.

In this era of open standards, and the utopia of unimpeded data flow among departments, there should be an enterprise-level thread running through any investment. There is no justifiable reason today to buy spot solutions which go on to create new content silos and integration complexity. More and more companies are realizing this now. Many software RFPs are broadening beyond single-use applications.

With a common platform at the core, as well as feeling instantly familiar each new application will be able to draw on, and add to, the same pool of knowledge and data which sits behind other, linked applications. For Regulatory teams, this paves the way for essential collaboration with adjacent teams looking after Quality, Safety, Clinical, Supply Chain and Manufacturing operations.

Assembling the right assessment team

Engaging the right people at the right time is another key success factor for change management efforts, and will ensure that these wider opportunities are explored.

From a change management perspective, the logical extension is that different departments must work together now – to find solutions that solve more than one problem; and offer superior economies of scale.

In fact, we’ve seen previously standalone and vehemently self-sufficient departments discover a wide range of mutual benefits – including simplified financial reporting – from working together more collaboratively. These wins continue long after any joint software requisition and implementation.

Understanding strategic opportunities like these, and engaging stakeholders from multiple disciplines from the earliest stages of any new IT or process transformation initiative, should be key facets of any change management strategy as life sciences companies invest in next-generation capabilities.

Lisa Cooney is Director of Operations Transformation for Life Sciences at Grant Thornton in the Greater Philadelphia Area in the US. She is a specialist in business change enablement, particularly linked to Regulatory and Clinical Development change.