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    • Accelerating UK Approval Timelines

    Case Study

    Scientist holding digital device
    • Sponsor faced delays with MHRA and REC approvals in the UK when using a large, global CRO
    • VCTC was selected as one of several UK sites for a global, multi-centre trial
    • Competitive global recruitment required expedited UK site activation, to meet enrolment goals
    • Sponsor needed a minimum EU/UK participant pool to support EMA marketing approvals

    Overview

    VCTC supported a CRO and Sponsor in addressing delays with MHRA and REC approvals in the UK for a multi-centre, global trial. These delays, typically extending approval timelines to 9-12 months, were due to the CRO's requirement tosubmit all UK selected sites in the initial submission. This required the collection of all site documents from both NHS and commercial sites prior to submission. This process was slowed significantly by UK sites with lengthy internal approval procedures.

    To align with the global trial's competitive recruitment timelines and meet the Sponsor's need for a minimum EU/UK participant pool for EMA marketing approvals, VCTC implemented a novel submission strategy to expedite the process.

    The project posed significant challenges, including:

    • Delays caused by slow document collection at UK sites with lengthy internal committee processes.

    • CRO’s requirement for all UK site documents to be collected before MHRA/REC submission, and all selected UK sites to be included in the initial submission.

    • Ensuring UK site activation aligned with global competitive recruitment timelines.

    • Meeting the Sponsor’s requirement for a sufficient EU/UK participant pool.

    Tactics

    • Streamlined Initial Submissions: Submitted with two sites - one NHS coordinating center with the Chief Investigator and VCTC as a commercial site, utilising one PIC (Participant Identification Centre). This minimised document collection requirements to two sites, significantly reducing delays
    • Efficient Document Collection: VCTC and the coordinating NHS site committed to providing all necessary documents within two calendar weeks.
    • Staggered Site Submissions: While the initial submission was under review, document collection for additional UK sites continued. A substantial amendment was submitted to add these sites after initial approval.
    • Rapid Approval Process: Achieved initial approval for the NHS site, VCTC site, and PICs within 60 days. Approval for subsequent sites was received within 35 days following the substantial amendment

    Outcomes

    • Reduced timeline for site selection to study approval - from 9 months to 4 months
    • Achieved 2 months for CRO submission process and document collection for two initial sites
    • Secured study approval within 2 months of submission to MHRA/REC
    • Shortened start-up timeline for all UK sites from 9-12 months to 6 months

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