Defining When To Implement Technologies To Support Commercial Growth
By Wes Ange and Irene Birbeck, Clarkston Consulting
Another invitation to join a software demo just hit your inbox — one you didn’t even know about. And it’s not the first. If you’re like many IT leaders in life sciences, this might be all too familiar. With two candidates in Phase 3 trials showing positive results, your company is gearing up for a commercial launch. The headcount is rising, processes are being established, and yet…different leaders are out there, finding tech solutions on their own. It’s great to see their initiative, but if you’re feeling like you’re about to pull your hair out, you’re not alone.
Leading IT for a rapidly growing life sciences company isn’t easy. You’re constantly balancing urgent requests, complex decisions, and the pressure to stay ahead of the curve. It’s enough to make anyone feel stretched thin. The good news is: you’re not alone in this struggle, and there’s a proven way to get everyone back on the same page. Imagine transforming this chaos into a coordinated, strategic approach where technology decisions are aligned with your company's goals and timelines. It’s not just possible — it’s achievable with the right steps. Even the most well-intended business partners can go rogue. To stop this, you will be tempted to immediately jump to defining the vendor selection process for new software providers. That step is critical, but it shouldn’t be the very first action.
To make any individual technology decision, it must be understood in the context of your business strategy and projected growth trajectory. It’s not your job to define the commercial plans. However, it is your responsibility to understand and help communicate the decisions and potential inflection points to your business partners when helping them make system decisions. You must guide your business partners to business process and technology decisions with an IT road map. This article explores how understanding your company's commercial goals, deciding between in-house and outsourced capabilities, and clearly defining requirements can help you create an effective IT road map that brings order to the chaos.
Key Elements To Consider
1. Defining Key Dates And Commercial Milestones
The first step is identifying key company target dates or milestones to anchor to major technology decisions. While it’s tempting to plan around quarters, anchoring decisions to key milestones — like trial results, submission dates, or approval timelines — offers greater agility. This approach ensures that your technology solutions are ready when your business needs them most, without the pressure of arbitrary deadlines that potentially start spending too soon.
With an understanding of the product launch key dates, it is time to align on the commercial sales targets. A great starting point for those milestones is expected sales numbers within six months of launch and then over the next three years. As you discuss sales targets, you'll quickly encounter various caveats from your sales leaders. It can be frustrating when sales targets come with a list of “what-ifs” and uncertainties. However, these detailed discussions will strengthen your planning by highlighting factors that could impact when and what technology is needed. Embracing this complexity now means fewer surprises down the line.
Layered into the anchored milestones is reversing into the time needed to implement a specific solution. Considering the length of time needed to select the vendor, complete configuration, transfer data, and train, it may be multiple months to over a year before a technology solution is prepared to support your business operations.
Companies that do this most successfully document the objectives over year one, two, and three with additional notes related to new products coming to market or expanding therapeutic areas or even additional technology platforms. By anchoring to the milestones, this will give you a good understanding of when to begin the selection process. It will be a lot to juggle, but taking the time to understand and communicate the commercial goals will put you in a much stronger position to guide your business partners to the right technology decisions at the right time.
2. Deciding Between In-House Versus Outsourcing
Pivoting from what the company is going to accomplish, the focus then turns to how it will be executed. At the very highest level, this decision focuses on what capabilities will be completed in-house versus what will be outsourced. The goal of this article is to relay the importance of understanding and communicating outsourcing decisions and position when defining an IT road map, not how to make those decisions. To go in-depth about how to make the decision, you can read more here.
One early decision that your business partners are likely already aware of is if and when contract manufacturing organizations will be utilized. Your company may already be working with one during clinical production and plans to continue through commercialization. In other cases, manufacturing for clinical is done in-house and identifying a partner CMO is expected to help scale for commercialization or grow in specific regions. Other decisions may include outsourcing patient safety or relying on a third party to execute your sales strategy. Understanding the current planned future path for in-house versus outsourced decisions has a significant impact on the company’s compliance responsibilities and the technology needed to support your business partners.
Outsourcing can offer cost savings and access to specialized skills, but it can introduce challenges around data security and provides less direct control. Conversely, keeping functions in-house ensures greater oversight and customization but may require more resources and infrastructure. More than anything, these decisions will require additional data security, privacy, and access considerations for your company that should be layered into your road map and requirements.
The goal here is not to pin down the organization to a specific decision but rather be agile and nimble. These decisions are not set in stone. As your company grows and market conditions change, so will your strategy. Thinking back to the initial commercial targets, a common strategy is to use a CMO at launch and then build the manufacturing capabilities in-house for the next asset. What you want to establish is a framework that informs your decision on what is kept in-house versus what is outsourced. With a framework in hand, you have helped to prepare your company to pivot smoothly when needed.
3. Collecting Requirements, Not System Requests
The last step is collecting a set of requirements from your business partners based on the commercial scale of the company. For instance, with only one product on the market and a slow ramp up, your regulatory group may feel that it is reasonable to continue managing their work through SharePoint and emails. Perhaps at clinical scale, the quality team can manage on paper, but within the first six months of commercial success, they need a QMS and LIMS to support the number of batches being manufactured.
It's natural for your business partners to have strong preferences, and you might face pushback when steering the conversation toward requirements. As such, try framing discussions around outcomes. Ask yourself: “What do we need to achieve?” This keeps the focus on goals rather than specific tools and fosters collaborative problem-solving. Your job as the IT leader is to form a coherent technology road map and landscape to position your company for success. With the system requirements laid out, you can now layer in considerations back to the previously mentioned security, system interoperability, license models, additional reporting needs, etc.
A completed vision and road map will likely involve some technologies people have used before, some they have not, and some that they are familiar with but being used in different ways. So, work closely with your business partners to thoroughly understand their processes, requirements, and challenges. Start by conducting workshops or interviews with key stakeholders to gather detailed requirements. Prioritize these based on impact and feasibility, and document them clearly. Investing time up-front to define clear requirements not only leads to better technology choices but also minimizes costly changes and rework down the line. It also sets the stage for smoother implementations and higher user adoption rates.
4. Aligning Value To Spend
With all these components in place, the baseline for the multiple variable equation is in place: what technology solutions will be needed based on the agreed commercial model, when they will be needed based on the expected commercial milestones, and a list of requirements driving the decision.
Without a framework in place, your different business partners may not understand why they can’t have a particular solution now or at all. By putting this approach in place, your goal is to partner with them to drive strategic value and innovation within your organization. Your foresight and planning are key contributors to the company's commercial success. You and your business partners will have alignment on priorities and strategy that will allow you to guide your company to invest in and scale technology at the right time and at the right level. By doing this, you can protect against overspending on technology or investing too early, in turn saving money. You also protect against rushed implementations that will push your colleagues to work late nights and weekends.
Final Thoughts
So, what’s your next move? Schedule a meeting with your CEO and commercial leads. Start asking those key questions about your company’s milestones. The sooner you begin, the sooner you can guide your company with confidence — knowing that your IT strategy is aligned, your partners are informed, and you’re ready to support a successful commercial launch with a well-structured technology roadmap.
About The Authors:
Wesley Ange started with Clarkston Consulting in 2005, serving both the consulting business and adjacency companies ever since. He spent more than a decade working with FoodLogiQ, a software company and former Clarkston adjacency, in various roles, including VP of customer success. He has experience in project management, process improvement, and organizational change management for large-scale transformational initiatives. Ange also has broad industry expertise — spanning the life sciences and food service sectors — and a wealth of technology experience, from laboratory information management systems (LIMS) to point-of-sale solutions. Ange received his B.A. from UNC-Chapel Hill, with a double major in chemistry and communication.
Irene Birbeck is a managing partner with Clarkston Consulting. In her client work, she specializes in the implementation and optimization of complex, global quality systems. Her industry experience spans companies within life sciences, specifically in the cell and gene therapy/biotechnology sector, and the consumer healthcare and chemical industries. In addition to quality systems implementations, Birbeck has managed projects related to R&D, commercialization, and commercial manufacturing. She is also passionate about helping companies in business process optimization. Birbeck received her B.A. in public policy with a concentration on science and technology policy and a B.A. in communications studies from the University of North Carolina at Chapel Hill.