There are many benefits of implementing an end-to-end Regulatory Information Management (RIM) system including the impact on regulatory compliance, speed to market, and revenue.  A robust RIM solution can optimize collaboration and streamlined processes driving higher quality work, faster. However, to reap these benefits, organizations need to ensure they have a strategy in place as they embark on this journey.

Without the proper plans in place, it’s easy to miss key information along the way leading to sub-optimal implementation and lagging user adoption.  In order to avoid these pitfalls, it is critical that organizations prepare sufficiently for this change, both from a people and technology perspective. Having a solid plan is extremely important to ensuring a successful implementation. As Benjamin Franklin once said, if you fail to plan, you plan to fail.

In this blog, we will discuss 2 key steps that will ensure a successful result. Although seemingly intuitive, there are nuances that will ensure critical activities are not overlooked. These two critical steps should not be missed on your journey.

Define Your Vision

Guiding Principles & Vision

The first step is defining the company’s vision. This is done by bringing the group together and working with the leaders in the organization to develop a vision statement, along with guiding principles. The objective is to collate a succinct set of goals that the organization can retain as the selection and implementation criteria standards for the future state. For example, the organization might want to speed up submission times as a goal so that the quality can be improved or both. Another area might be authoring more efficiently. There may be other aspirations that each organization has to get on a journey towards an end solution.

“As is” State of the Business

While developing the goals, there should also be a baseline of where the organization is today. Many organizations may have the desire to jump ahead and dive into the new, shiny, exciting possibilities of the future state and systems that can help get you there, however, having a solid sense of where you are now before embarking on the best path to improvement is critical.

We’ve seen many organizations get tripped up because they don’t know what they don’t know, and with global processes, various tool, spreadsheets, SharePoint emails, any other aspects, it’s very easy to miss a critical piece of the puzzle, if you don’t step back and develop a solid plan.

It starts with defining the scope of the work and following up with business processes. The organization should also review the system landscape, issues, gaps, and areas of opportunity. This helps in bringing to light the areas that are not clearly apparent.

“To be” State of the Business

After the “as is” state has been developed, the organization can learn from that, the vision, and guiding principles to bring those together and define what the future state or “to be” state will look like.

Then depending on how you’re going to go about implementation there may be the need of a different level of detail in your future state. Astrix’s recommendation is to start by mapping out what you’re looking to do from a high-level process flow. From there, the organization can dive in deeper as needed. This can be an iterative process. As you learn more about your organization’s needs and the vendor capabilities, and as you get closer to the solution selection, you can iterate back on that future state and add detail as you learn more.

Identify Capabilities

Another piece of the puzzle is identifying and prioritizing the capabilities – understanding what is needed to maintain continuity (what you have today) and to bridge the gaps (what is needed in the future). Ask yourself, will these capabilities enable the organization to reach the desired future state? Does the organization have the right technologies, for example analytics recording, or workflow orchestration, in place already?

Identify and documenting these needs will allow the organization to better assess the vendors as you move forward into a solution selection and ultimately drive your implementation later on.

Once you know the capabilities you need to implement, if you haven’t already, make sure to take the time to fully assess technology options and evaluate based on the organization’s specific requirements. Organizations typically view even foundational capabilities in very different ways, so, look at these technologies based on what your organization needs and how they will fit into your specific situation.

Summary

It is critically important, when building out a strategy and plan relative to any new business and/or technology endeavor, to have the right internal staff and external organizations involved to assist in the process. Formulating the appropriate approach along with the proper processes and technology is imperative.

Astrix’s team of professionals in our Strategic Consulting Service Practice have worked with many of the top life science organizations and leaders to assist them with respect to their business needs in these areas. As a technology-agnostic partner, without a preconceived preference for a specific supplier or product, we work closely with your team to ensure solutions are reviewed and incorporated into your business so that you succeed in realizing your vision and achieving your organizational goals.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.