Our last blog post looked at what is required for a clinical trial unit to achieve an MHRA accreditation, including a commitment to the highest safety standards, comprehensive procedures and processes, and capable, experienced teams.
The benefits of an MHRA Phase I accredited site, inspected and approved by regulators, remain the same for a patient study – especially if you are seeking a high-quality, safety-focused, experienced site to partner with. Your patient trial can benefit from rapid start up timelines, a fully equipped Facility which can provide overnight stays and dedicated experienced resources to ensure delivery.
When seeking a CRO to partner with, their patient recruitment and retention strategy will be key to keeping your study on track, and the reassurance of an MHRA accreditation can help reassure patient participants that their safety is the highest priority.
An experienced project team will enable rapid set up from contracting to First Patient In. Most MHRA Phase I accredited units have a dedicated recruitment team who will be able to utilise their own database, their primary and secondary care network, and links to patient advocacy groups to set a study specific patient recruitment strategy whether it be for a hybrid healthy volunteer/patient protocol, a phase Ib/IIa patient study or acting as a site as part of a multi-site international phase III patient study.
If you are conducting a study with both healthy volunteer and patient cohorts utilising innovative or adaptive trial design, it is worthwhile considering a CRO with an MHRA Phase I accredited unit. The MHRA welcomes clinical trial applications using innovative trial design, including umbrella and basket protocols, however the choice of this trial design must be justified. Selecting a CRO with an MHRA Phase I Accredited Unit, who is experienced with both innovative trial designs and has established interactions with regulators and ethics committees can ensure your study is safe, scientifically sound, and acceptable to regulators. Simbec-Orion’s team is available to support with clinical trial design and protocol writing, and for additional support, Simbec-Orion’s Drug Development Advisory Board has the expertise of Dr Kirsty Wydenbach, an independent consultant and former Medical Assessor for the MHRA’s clinical trials unit. Kirsty was an EMA expert for the update of the First-in-Human guideline and Kirsty’s other work has included collaboration with external industry groups and regulators regarding adaptive and novel trial designs and leading the MHRA work on novel trial design for the Life Sciences Industrial Strategy as well as through the new MHRA Innovative Licensing and Access Pathway (ILAP).
Contact us to find out how Simbec-Orion’s combined clinical pharmacology and patient experience can support your early clinical development plans.