LOCAL IR(ME)R REVIEW | 90-DAY SITE SET-UP SUPPORT

 The Ionising Radiation (Medical Exposure) Regulations (IRMER) are UK legal requirements that protect patients involved in clinical trials using radiation or medical imaging. 

While national Radiation Assurance provides study-wide MPE/CRE review through the HRA/IRAS pathway, each NHS Trust or research site still retains local IR(ME)R responsibilities before a study can open locally.

Local IRMER reviews ensure that:

• Imaging protocols are justified and optimised for the specific site
• Appropriate equipment and expertise are available locally
• Patient radiation exposure is minimised and properly monitored
• All local regulatory requirements are met

These reviews must be completed by qualified Medical Physics Experts (MPE) or Clinical Radiation Experts (CRE) with appropriate accreditation. 

However, many research sites lack the internal capacity to complete these reviews promptly, creating significant delays in trial activation. Recent guidance encourages sites to reduce duplication and rely on national RA outputs, but local IR(ME)R responsibilities for justification and optimisation remain - and capacity constraints persist. 

• How many studies are currently sitting on your desk awaiting local IRMER sign-off?

• Could local IRMER review delays be the primary bottleneck preventing faster study activation at your site?

• Are you declining or postponing industry-sponsored studies due to IRMER capacity constraints?

• How much commercial income are you missing from delayed patient recruitment due to IRMER backlogs?

• Could faster local IRMER completion improve your site's attractiveness to sponsors and CROs?

• Are competing clinical demands on your physics team creating unpredictable research timelines?

• How would consistent 5–10-day local IRMER turnaround transform your study portfolio?

• Accelerate Study Activation — Achieve consistent 5–10-day local IRMER completion times compared to typical 6–10-week internal timelines, helping sites meet national expectations.

• Free Up Clinical Resources — Allow your internal physics teams to focus on clinical priorities whilst we handle local IRMER reviews efficiently.

• Improve Patient Access — Enable faster study opening so local patient populations can access novel diagnostics and investigational medicines sooner.

• Increase Commercial Revenue — Earlier site activation leads to increased per-patient commercial income and improved attractiveness to sponsors and CROs.

• Reliable Specialist Access — Ensure availability of accredited MPE/CRE reviewers when you need them, not when internal capacity allows.

• Deliver Predictable Timelines — Offer standardised documentation pathways and pre-agreed turnaround times so you can plan with confidence.

• Maintain Regulatory Quality — Ensure all local IRMER reviews meet IRMER requirements and regulatory standards without compromise.

• Enhance Site Competitiveness — Help improve your feasibility scores and likelihood of selection for future commercial studies.

• Guidance-Aligned Approach — Our reviews follow updated HRA/UKCRD IR(ME)R guidance, focusing on genuine local requirements while avoiding unnecessary duplication of national RA work. 

• Secure & Certified - Nclusiv is Cyber Essentials certified, ensuring your  sensitive clinical trial protocols and site documentation are protected through robust cybersecurity practices throughout our local IRMER review process.

• Study documentation receipt — We receive your trial protocol and imaging requirements for local IRMER assessment

• Specialist reviewer allocation — We assign accredited MPE/CRE reviewers with relevant imaging modality experience

• Rapid review completion — Complete local IRMER reviews within 5–10 days with full regulatory compliance

• Clear documentation delivery — Provide standardised reports and documentation required for study activation

• Query resolution support — Single-point-of-contact communication for any questions or clarifications needed

• Ongoing study support — Available for amendments, protocol changes, or additional imaging requirements throughout trial duration

Example: NHS Trust portfolio support

The Challenge: One NHS Trust had a portfolio of studies awaiting local IR(ME)R review due to internal capacity constraints.

The Solution: Nclusiv provided outsourced local IR(ME)R review support using experienced MPE/CRE reviewers, helping the Trust reduce backlog pressure and progress studies towards activation more quickly.

The Results: The outcome was a more predictable review route, reduced pressure on internal clinical teams, and improved ability to support commercial research delivery.

• All trials (up to 30) activated within planned timelines
• Patients gained earlier access to investigational therapies
• Trust secured commercial income from patient recruitment
• Site became more attractive for future trial selection
• Internal physics team refocused on clinical priorities

National Impact Of Local IRMER Review Delays

Preliminary research across UK Clinical Trials Units reveals:

• 6–10 week delays are typical for internal local IRMER reviews due to competing priorities

• Multiple studies sit on desks at major NHS Trusts awaiting local IRMER completion

• Patient access to novel therapies is delayed by IRMER capacity constraints

• Commercial opportunities are lost when sites cannot activate studies promptly

• Predictability of timelines is as valuable as speed for R&D teams