Quality assurance

Our quality management system and dedicated quality assurance review team conduct a rolling programme of audit and process improvement. This ensures our procedures and systems are updated as required to reflect changes in clinical trials processes and regulations and are continually refined to improve efficiency in trial conduct and analysis.

We work closely with the UK’s Radiotherapy Trials Quality Assurance group to ensure that our trials of novel radiotherapy techniques are conducted to the highest possible standard, prioritising patient safety at all times.

Our Operations Director and Assistant Operations Directors sit on national and international groups and contribute to policy and regulation development to ensure that our expertise in efficient conduct of quality complex research is shared with the wider clinical trials community.

IT systems

Our dedicated team of clinical trial IT specialists maintain our clinical trials systems. MACRO is our clinical database used for electronic data capture directly from participating sites. MACRO is ICH GCP and FDA 21 CFR compliant. We work closely with the ICR’s specialist Information Governance team to ensure our processes and systems appropriately protect our participants’ confidentiality.

Secure file transfer

Large files may be transferred to our team via the ICR’s ZendTo service.

No identifying information about our trial participants should be sent to us via unencrypted email. The ICR’s recommended system for transferring patient identifying data is Egress.