Before you build your SCE, you need to know exactly what you're building.
A Statistical Computing Environment implementation touches infrastructure, validation, process, and people simultaneously. The decisions you make before you start — platform architecture, integration approach, validation strategy — determine how smooth the implementation goes. Our 12-week scoping engagement gives you clarity, documentation, and a ready-to-execute plan before a single production server is provisioned.
Most SCE implementations run into trouble because planning was treated as an implementation task, not a precondition.
The organizations that struggle with SCE deployments typically have the same story: they underestimated how many systems their SCE needs to connect to, how much the validation approach would depend on decisions made in configuration, and how different individual teams' requirements turn out to be when you actually sit down and gather them. Discovering this mid-implementation is expensive. Discovering it before is not.
Requirements surface late
User requirements gathered in implementation — rather than before it — create rework. What one department assumes is standard operating practice is often highly specific. The gap between assumptions and reality costs weeks.
Architecture decisions have long tails
Where your data lives, how environments are structured, which Git platform you use, how permissions are managed across studies — these choices constrain everything that comes after. Revisiting them mid-build is costly.
Validation planning without a design is guesswork
Your QA team needs to know what they're validating before they can scope the effort. A scoping engagement produces the design artifacts that make validation planning tractable.
IT involvement starts too late
By the time IT understands what the platform actually requires — network access, storage, identity integration — dependencies have already been built around incorrect assumptions.
Twelve weeks. Five phases. One implementation-ready plan.
At the end of this engagement, you have everything you need to begin a confident, scoped implementation — with the architecture documented, the requirements gathered, the proof of concept validated, and the team aligned.
Kickoff
Week 1Contracts initiated. Teams introduced. Access configured. Systems reviewed where applicable. The foundation for productive discovery is in place before week two begins.
Discovery
Weeks 2–4We run structured requirements-gathering sessions with both business and IT stakeholders. Departmental processes mapped. Current-state tooling and data flows documented. Pain points surfaced. Legacy system constraints identified. The result is a clear picture of what the SCE must do and what it must integrate with.
Proof of Concept and System Mapping
Weeks 5–7A structural proof of concept is built in your SCE — not production code, but a working model of the architecture. Applications, databases, and external systems are catalogued. Draft architecture diagrams and process flow diagrams are produced for review.
Refinement
Weeks 8–11Documentation is refined with stakeholders. The proof of concept evolves to include functional code, applications, and representative workflows. The implementation plan is drafted — with timeline, resourcing, and scope defined.
Handoff
Week 12Knowledge transfer sessions conducted. All documentation finalized and formally handed off. Your team has what they need to move into implementation with confidence.
The deliverables that make implementation go right.
These aren't slide decks. They're working documents your team, your QA function, and your IT organization will use directly in implementation.
User Requirements Specification (Draft)
A structured URS capturing requirements from both business and IT stakeholders, formatted for use in your validation process. Not a template. A populated document built from your actual requirements.
System Architecture Documentation
Integration diagrams, system inventories, and data flow documentation covering every connection between your SCE and your existing infrastructure.
Proof of Concept
A working structural model of your SCE, demonstrating the proposed architecture and key workflows. Your team can see the environment before committing to implementation.
Implementation Plan
A scoped, resourced, sequenced plan for your full SCE deployment — ready to hand to an implementation team or use as the basis for an SOW.
Process and Workflow Documentation
Documented process flows for the statistical programming workflows that will run in the SCE, aligned to your organization's actual operating practices.
How KSM runs a scoping engagement.
The value of this engagement depends on access and participation. Here's what we bring, and what we need from your organization to make it work.
Deep platform expertise and SCE implementation experience across the pharmaceutical industry. Facilitation of structured discovery sessions. Proof-of-concept development. Documentation production. Regulatory and validation context that shapes every architecture decision.
- Business and IT stakeholders available for discovery sessions in weeks 2–4
- Access to non-production legacy systems for current-state analysis
- A development environment accessible and configured
- Mock or anonymized test data (SDTM, ADaM, TFL formats) for proof-of-concept work
- Dedicated decision-makers available in weeks 8–11 for refinement and plan review
Key assumption: The scoping engagement surfaces requirements and produces a plan. It does not produce production-ready code or replace the validation activities your quality team must execute.
The right engagement for the right moment.
The 12-week scoping engagement is designed for organizations that have made a serious decision to evaluate or implement an SCE platoform — but haven't yet committed to a full implementation. It's also the right starting point for organizations that have been burned by implementations that started without enough planning.
If your organization has already completed requirements gathering and is ready to move directly into implementation, our Domino SCE MVP Deployment may be the more appropriate engagement.
Learn about the Domino SCE MVP Deployment →- Evaluating or planning an SCE deployment
- Unsure of your full requirements before committing to implementation
- Managing multiple stakeholder groups with different expectations
- Operating in a regulated environment where validation planning matters
- Recovering from a previous implementation that started without enough planning