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SCE Modernization Discovery
Design Once, Validate Once, Go Live Sooner
Get the target design, implementation recommendations and a roadmap to a validated, modern and scalable SCE that takes your teams from data to submission faster.
Your next SCE, designed with QA in the room from day one
#The Problem
Why SCE Projects Run Late
Business defines the need, IT designs the solution, and QA sees it last. If a submission depends on the environment, rework delays the launch, and each day of delay is lost revenue.
Rework Late in the Project
Compliance requirements surface after the architecture is set, and the redesign is paid at implementation rates.
Qualification Becomes the Bottleneck
Without clear requirements and a technical design, there is nothing to estimate qualification against, and the go-live date drifts.
Decisions Stall
Tool and vendor choices drag on because nobody compares them on fit, cost and validation effort together.
#What You Get
A Signed-Off Blueprint for the Whole Build
Every open technical decision gets a recommendation, the reasoning behind it, and an owner.
Your SCE Blueprint
6 deliverables
Target Technical Design
Compute, storage, execution and environment promotion, integrated with the systems you run and the ones you plan.
Implementation Recommendations
Tools and vendors with trade-offs, build approach, first-release scope and backlog, and a team and effort estimate.
Compliance-Tagged Requirements
User and technical requirements in plain language, each marked for GxP relevance as it is captured.
Validation Strategy
A risk-based qualification approach for accuracy, reproducibility and traceability that QA can estimate against and that holds up at inspection.
Phased Roadmap
What must be ready by your deadline, what follows, and written scope boundaries for both.
Decision Pack
A go/no-go recommendation your leadership can sign off.
#How It Works
Business First, Design at the Core
Each layer builds on the one before, so the design solves the right problem and can be qualified from the start. Flexible format based on your and your team's needs, from one to three days on-site with business, IT and QA. Below is the full three-day format.
Before
Pre-Work
We review your documentation, systems and existing requirements, and agree who needs to be in each session.
Day 1
Align on the Business
Current and future processes, then user requirements in plain language, before any technology is chosen.
Day 2 · The Core
Design the Solution
Target architecture, tools and vendors, integration with your systems, and the path from development to production, with compliance requirements captured alongside.
Day 3
Validate and Sign Off
The risk picture and the design become a qualification strategy QA can commit to. Decision-makers sign off the roadmap before we leave.
After · Two to Four Weeks
Follow-Up
We consolidate the outputs into the final design, recommendations and roadmap, and walk your team through them.
#Who Runs It
Senior SCE Architect
Designs the target state with your team and challenges the assumptions under it, including ours.
Statistical Computing Engineer
Knows what production runs, study promotion and job orchestration cost on the stack you have.
Compliance Specialist
Part 11, Annex 11 and GAMP 5 experience. Writes a validation strategy your QA can sign.
Biostatistics QA Lead
Brings the study team's view: how biostatistics works day to day and what QA will ask of the environment, so the design fits both.
#Investment
One to Three Days, Scoped to Your Project
We agree the format on the scoping call, from one day to the full three-day workshop, and fix the price once it is scoped. Travel, pre-work and the compliance specialist are included. Deliverables follow within about two to four weeks.
If your submission depends on the new environment, plan for the full three days, so every decision on the critical path is made and signed off before the build starts.
Book a Scoping Call#Is This for You
Where Discovery Fits
Building or modernizing a GxP statistical computing environment
Adopting Posit, Domino or Databricks for validated work
Moving from SAS to R
Turning prototype tools into production software
Bringing AI into regulated workflows
Not a fit: skills training, a single app fix or a code review.
#Proof
Built From Real SCE Engagements
Global Pharma, Statistical Programming Environment
Management pulled the go-live forward by two quarters. Discovery gave QA what it needed to estimate qualification for the new date.
European Pharma, PK/PD and Clinical Statistics
The client chose Appsilon because discovery laid out a phased path from PK/PD simulations to clinical statistics.
#Valued by Clients Worldwide
Ebook for Clinical Data & Platform Leaders
The AI-Ready SCE: A Pharma Guide to Building Modern Environments
What a modern SCE has to include, how risk-based validation works in practice, where AI fits inside the compliance boundary, and how other pharma teams sequenced their builds.
Questions Before You Book
What clients ask before booking. Anything else, ask on the call.
01.
Is this a training workshop?
No. It is a decision engagement that ends with a technical design, implementation recommendations and a roadmap your leadership signs off.
02.
Do we need finished requirements before we start?
No. Building consolidated, compliance-tagged requirements with you is part of the work. If you have already mapped workflows and defined components, we start from your map.
03.
Does everyone need to attend every day?
No. Each session lists who is needed. Business stakeholders can skip the deep technical sessions. QA and the technical lead join the validation strategy session, and a project manager stays in the room throughout. Individual participants can join remotely.
04.
What if our QA team is stretched?
QA joins only the sessions where its input is essential, and the compliance view is represented throughout.
05.
Are you tied to a specific vendor?
No. We recommend the tools that fit your requirements, roadmap and validation effort, including platforms you already run.
06.
What happens after discovery?
You leave with a costed first release. Build it with your own team, take the plan to another vendor, or continue with us through embedded engineers, part-time validation support or phased build releases. If you continue, the next phase is scoped and priced within about two weeks.
#Contact Form
Planning a New or Modernized SCE?
We will contact you within 24 hours!
Next Step
Already Know What to Build?
We design, build and validate statistical computing environments in your cloud, and stay through go-live.