Independent RTSM & IRT consulting

Independent RTSM & IRT expertise for clinical trials.

Helping pharmaceutical and biotech sponsors make informed decisions, reduce implementation risk and deliver reliable clinical trial systems.

Support from protocol to go-live

Protocol — requirements analysis

Requirements — completeness and traceability

Design — independent design assurance

UAT — test scripts, execution and reporting

Go-live — readiness and change support

17+ years in RTSM/IRT

Independent — not an IRT vendor

Sponsors, CROs & IRT vendors

Consulting, design assurance & UAT

Services

Specialist support across the RTSM lifecycle

From a focused design review to hands-on UAT, each service is scoped around your study and the deliverable you need.

RTSM & IRT Consulting

Study implementation, project management, requirements analysis, supply strategy, vendor oversight and additional delivery capacity.

Independent Design Assurance

Independent review of study requirements, functional design, randomisation, dispensing, resupply and exception scenarios.

UAT & Test Scripts

Tailored test-script development, UAT execution, regression testing, defect tracking and test reporting.

Training & Knowledge Transfer

Practical RTSM/IRT training for clinical operations, supply and implementation teams.

Why RTSM Solutions

Specialist, independent and practical.

RTSM Solutions was founded by Matthew Strutt, drawing on 17+ years in RTSM/IRT across sponsors, CROs and IRT vendors.

Specialist focus

RTSM and IRT, rather than general clinical consulting.

Practical understanding

Grounded in how studies are designed and implemented in practice.

Independent advice

Client-focused recommendations. RTSM Solutions is not an IRT software vendor.

Flexible engagement

From a focused review to longer-term project support.

Who we support

Built for the teams that run clinical trial systems

Pharmaceutical & biotech sponsors

Specialist RTSM/IRT expertise when you need it, without hiring a permanent employee.

CROs & clinical operations teams

Project and implementation support, including detailed IRT specification reviews.

IRT & RTSM vendors

Experienced additional resource, UAT capacity, test scripts and regression testing.

How it works

A clear, agreed engagement

01

Discuss

An initial conversation to understand your study, challenge or required deliverable.

02

Agree scope

Scope, inputs, timeline, responsibilities and acceptance criteria agreed up front.

03

Deliver

The agreed consulting, review, test scripts or UAT support.

04

Report

Findings, evidence and recommendations in an agreed format.

Planning a clinical trial or reviewing your IRT arrangements?

Whether you need an independent design review, UAT support or experienced implementation resource, let’s discuss your requirements.