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A rescue study is a corrective initiative launched to address serious issues in an
ongoing or recently completed clinical trial—such as poor enrollment, data integrity
concerns, or protocol deviations. Its purpose is to restore the study’s integrity, reliability,
and regulatory viability.
Whether led by the original CRO or a newly engaged partner, a rescue study requires
rapid assessment, operational agility, and strategic execution to get the trial back on
track and protect the asset’s value. For sponsors, it’s a critical tool to prevent failure and
preserve the path to approval.
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We act fast. Initial assessments typically happen within days, with recovery plans
initiated shortly after agreement on the next steps.
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Yes. We offer collaborative models where we guide your existing team and provide trial
oversight—or we can fully assume control, depending on the situation.
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Data quality, protocol deviations, vendor underperformance, missed milestones,
regulatory findings, and more.
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Absolutely. Our team has supported studies in over 65 countries and understands the
nuances of local and global regulatory agencies.
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That’s common. We’re used to entering studies mid-flight and adapting quickly to the
environment, timelines, and priorities.
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Quite the opposite. Our interventions are designed to safeguard or even improve your
submission quality and chances of approval.