Scoping as Strategy: A Better Path to SCE Implementation
Client: Global Top-5 Pharmaceutical Company
Overview
A global top-5 pharmaceutical company with over a decade of experience on Domino Data Lab was preparing to undertake a full Statistical Computing Environment (SCE) implementation. Despite their platform familiarity, they had never formalized the process, user workflows, or organizational alignment needed to build a validated, enterprise-grade SCE. Rather than issuing a traditional RFP or jumping straight into implementation, they engaged KSM Technology Partners for a 12-week scoping exercise. What followed was not just a discovery process. It became the business case, the alignment mechanism, and the implementation foundation all at once.
Challenge
Experience with the Platform. Not with the Process.
Most SCE implementations begin with a significant unknown: the organization buying the platform understands what it does, but not how it should fit into their specific workflows, teams, and validation requirements. This client had been running Domino internally for years and had strong in-house IT capability. On paper, they were ahead of the curve.
In practice, they faced the same foundational questions every organization faces before a structured SCE implementation:
- How should statistical programmers actually interact with the platform day to day?
- Which applications and workflows make sense to automate or migrate?
- Where does the data come from, who controls access, and what is the source of truth?
- How do different teams — stats programming, data management, IT, and validation — coordinate across a shared environment?
These questions are not answered in vendor documentation or implementation guides. They require conversations that rarely happen organically across departments, and they require someone who has seen how other organizations have answered them.
There was a second, equally important challenge: building the internal business case. A full SCE implementation represents a multi-million dollar investment. The internal champion needed more than a vendor pitch to bring to leadership. She needed documented proof of what other organizations had done, what it cost, and what they got for it.
The RFP Problem
The traditional answer to “we’re evaluating a major platform investment” is an RFP. But RFPs for complex technical systems have a structural flaw: the questions are written by people who don’t yet know what they need to ask. The responses come back technically accurate and practically useless. For an SCE implementation, where the real decisions are about process design, change management, and validation strategy, a document-exchange process does almost nothing to advance organizational readiness.
Solution
A 12-Week Scoping Exercise as a Strategic Instrument
KSM proposed a 12-week scoping engagement before any implementation work began. The goal was not to produce a requirements document. It was to create the organizational and intellectual conditions for a successful implementation.
The engagement was structured around three interconnected outcomes:
Getting stakeholders aligned. SCE implementations touch multiple departments with different priorities and different vocabularies. Stats programmers care about workflow. IT cares about security and infrastructure. Validation teams care about documentation and traceability. Business leads care about timelines and cost. In most organizations, these groups rarely sit in the same room to discuss the same problem. KSM facilitated those conversations, acting as a neutral party with no stake in any particular organizational outcome. The value was less about what KSM contributed and more about what surfaced once the right people were finally talking to each other.
Contextualizing what is possible. Most users and business stakeholders at a pharma company have limited visibility into how other organizations have approached SCE implementation. They have no baseline for what a mature environment looks like, what tradeoffs others have made, or what pitfalls are avoidable. KSM brought that cross-industry perspective directly into working sessions, using demonstrations, process walkthroughs, and real examples to help the client see the landscape before committing to a direction. This is not information available in a vendor pitch or a reference call. It comes from practitioners who have built these environments before.
Building the internal business case. Perhaps the most underappreciated output of the engagement was what it gave the internal champion. Before the 12-week scoping exercise, she was preparing to present a case for a multi-million dollar implementation to senior leadership with limited supporting evidence. After it, she had documented process flows, architectural options, peer comparisons, and a clear articulation of what the investment would produce. When leadership asked “why should we spend this much money?”, she could point to what comparable organizations had built, what it took, and what they got. That kind of specificity is what moves decisions at the executive level.
What the Documentation Actually Needed to Be
One of the important realizations during this engagement was that the deliverable the client actually needed was different from what was originally scoped. The initial statement of work called for an architecture document. But this client already knew the platform. They did not need a technical explanation of infrastructure components or deployment options.
What they needed was a business process document: how do users interact with the environment? What does a typical study workflow look like end to end? Which decisions sit with stats programming versus IT versus validation? How do the apps connect to the data? KSM shifted the emphasis accordingly, focusing the documentation on process flows and user-facing decisions rather than infrastructure diagrams.
This is a meaningful lesson for how to scope these engagements. The architecture conversation matters, but it is not the conversation that unlocks organizational alignment or executive approval. The user workflow conversation is.
Lessons from the Engagement
No engagement surfaces only wins. Two patterns from this project are worth naming directly, because they are recurring challenges in large pharma scoping work.
Decision-making concentration matters. When questions about a specific domain required input from too many people with no clear authority to decide, progress stalled. The most productive conversations happened with individuals who had genuine ownership over their area and could make calls on the spot. When that person existed, the scoping work moved quickly. When decisions required group consensus across a large stakeholder set, meetings produced more questions than answers. For future engagements, KSM now pushes earlier and more explicitly to identify who holds decision-making authority in each functional area.
Stakeholder identification should happen on day one. In this engagement, several key stakeholders were identified in the final third of the project. Their involvement changed the questions being asked and required revisiting work that had already been completed. The fix is straightforward but requires discipline: insist on a full stakeholder map at the start of the engagement, and keep those stakeholders informed throughout rather than presenting to them at the end.
Results
The 12-week scoping exercise concluded with the internal champion better equipped to make the case for implementation than she would have been through any alternative process.
Internal alignment. Stakeholders across stats programming, IT, and business functions had been brought into the same conversation, in many cases for the first time. Competing assumptions about how the SCE should work had been surfaced and worked through rather than left to become implementation problems later.
A practical implementation foundation. The scoping documentation gave the implementation team a head start that a cold start would not have provided. Process flows, user interaction patterns, data source decisions, and application migration priorities were documented and agreed upon before any implementation work began.
Executive-ready justification. The internal champion had the documentation, the peer comparisons, and the process clarity needed to present a credible case for a significant capital investment. The scoping exercise did not just prepare the organization for implementation. It created the conditions for the decision to happen.
Why This Approach Works
The 12-week scoping exercise is not a lighter version of an RFP. It is a fundamentally different instrument. An RFP asks an organization to specify what it wants before it knows enough to ask the right questions. A structured scoping engagement builds that knowledge first, then produces a document grounded in actual organizational context.
Impartiality has real value. KSM comes into these engagements without a stake in any internal political outcome, any particular technical direction, or any budget allocation. That position makes it possible to run conversations that internal teams cannot easily run themselves. People say things to an outside party that they will not say in an internal meeting.
Cross-industry experience is the product. The single most valuable thing KSM brings to a scoping engagement is not a methodology or a document template. It is the accumulated knowledge of what other organizations in similar positions have done. What worked, what did not, and what the common failure modes look like. That perspective cannot be purchased through a vendor demo or a reference call. It comes from practitioners who have built these environments, across multiple companies, over many years.
Timing is the variable that changes everything. The same conversations that happen during a 12-week scoping exercise will happen at some point in every SCE implementation. The question is when. When they happen before implementation begins, the decisions they surface can inform the work. When they happen during implementation, they create rework, cost overruns, and missed deadlines. Getting stakeholders aligned and the business case built before the first statement of work is signed is not a luxury. For a complex implementation, it is the prerequisite for doing it right.
Interested in how a structured scoping engagement could de-risk your SCE implementation? Contact us to start a conversation.