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Regulated Data & AI Engineering

Forward-Deployed Engineering & Strategic Consulting

Senior engineering collaboration remotely or on-site by agreement, and standalone strategic consulting for AI, data and regulated workflows.

A defined path to production

Fixed-price diagnostics and implementation projects, with scope, deliverables and acceptance criteria agreed before work begins.

Diagnostic

Understand the workflow, establish a baseline and assess risks.

An agreed architecture, implementation plan and acceptance criteria.Discuss your workflow

Fixed-scope implementation

Build the agreed functionality, integrations, tests and technical controls.

A working system with documented evidence and agreed deployment outcomes.Discuss your workflow

Acceptance & handover

Review results with domain experts and complete the agreed deployment.

Documentation, operating guidance and transfer of operational knowledge.Discuss your workflow

Inputs and discovery

Bring a workflow description, system inventory, representative non-sensitive examples and the relevant technical and quality stakeholders. Agree access arrangements before sharing project data.

Scope and boundaries

Define deliverables, dependencies and responsibilities together. Production rollout, migration and customer validation are included only when explicitly agreed. Dates and pricing follow the scoped proposal.

Review and handover

Agree acceptance criteria and review owners at the outset. Review the architecture, implementation and test evidence, then hand over documentation and operating guidance appropriate to the engagement.

Agreed engineering deliverables

  • Workflow and architecture specification
  • Documented implementation and test evidence
  • Review, deployment and handover plan

Designed to support validation under the customer’s quality system. Validation responsibilities, acceptance criteria and human review are agreed explicitly; automation does not replace accountable quality review.

Case Studies

Selected engineering projects

Anonymized project experience in Financial Services, Life Sciences and self-hosted AI automation, with concrete approaches, results and lessons learned.

Technologies and standards chosen for the workflow

Statistical computing

R · Python · SAS · SQL

Clinical workflows

CDISC · SDTM · ADaM · Pinnacle 21 · TLF

Private AI

LLMs · RAG · on-premise · private cloud

Applications

Shiny · APIs · dashboards

Contact

Discuss your workflow

Senior engineering collaboration remotely or on-site by agreement, and standalone strategic consulting for AI, data and regulated workflows.

info@leap-dynamics.com+49 (0) 30 62939513Scharnhorststraße 24, 10115 Berlin

We usually respond within two business days.

Please do not include health data, credentials, confidential records or production datasets in this initial inquiry.

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