Operations & Workflow Optimization
“Improve your structure and clinical research framework”
Structure applied to how clinical work is run — studies, documentation, and standard operating procedures — so the same rigor that makes your evidence defensible makes your operations efficient and audit-ready.
Typical Deliverables
The Problem
Clinical work outgrows the tools that hold it. Investigator-Initiated Studies are tracked across spreadsheets and shared folders; study documentation is scattered and hard to keep audit-ready; SOPs drift from how the team actually works, or were written once and never revisited. Manual, repetitive steps slow everything down and quietly create compliance risk. None of this is a science problem — it is a workflow problem, and it rarely gets solved by adding more documents.
The Approach
The same structural thinking that aligns clinical claims to evidence aligns internal operations to strategy: starting from how a team actually works, mapping where studies, documents, and decisions get stuck, and designing lightweight systems that fit the real process — not an idealized one.
Because the same person handles the clinical science, the regulatory framework, and the statistics, the resulting workflow stays consistent with the underlying evidence and obligations. One expert, no handoffs.
Service Catalog
Investigator-Initiated Study (IIS) Management
Structured governance of the full IIS lifecycle — intake, review, contracting, milestones and payments, document checklists, communications, and close-out — instead of email threads and spreadsheets. The workflow can be built around existing SOPs, or delivered as a purpose-built management tool tailored to those procedures.
See it in action: a live, interactive IIS management demo (synthetic data) is available now. Explore the IIS demo →
Process Automation
The repetitive, manual steps in clinical and regulatory workflows — tracking, reminders, status reporting, document assembly, data extraction — get replaced with reliable, auditable automation. The goal is fewer handoffs and fewer transcription errors, not technology for its own sake.
Medical Writing & Study Documentation
Clear, regulation-aligned study documentation — clinical investigation plans (CIP), investigator brochures (IB), statistical analysis plans (SAP), reports, and the supporting forms — written by the same scientist who understands the underlying data. Includes reusable, audit-ready templates so future documents stay consistent and faster to produce.
SOP Audits & Revisions
A structured review of existing standard operating procedures against ISO 14155, EU-MDR, and ICH E6(R2)/GCP — and against how the team actually works. Gaps, contradictions, and shelf documents get identified, then revised into practical, usable SOPs with clear responsibilities, process flows, and templates that people will actually follow.
Standards & Frameworks
Operations and documentation work is delivered in line with:
- —ISO 14155 — Clinical investigation of medical devices
- —EU Medical Device Regulation (EU) 2017/745 — Chapter VI
- —ICH E6(R2) — Good Clinical Practice
- —GAMP 5 — Validation of computerised systems (for any deployed tool)
- —21 CFR Part 11 — Electronic records & signatures (where applicable)
Want to streamline how your studies, documents, and SOPs are run?
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