SOP Gap Assessment
Find out what's missing before an inspector does.
You share your existing SOPs. We review them against ICH E6R3 requirements and your study portfolio, then deliver a written report identifying what's missing, outdated, or misaligned — with a prioritized list of what to address first.
No judgment, no upsell pressure. Just a clear picture of where your documentation stands.
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Review of up to 15 existing SOPs
Written gap report with prioritized findings
30-minute debrief call to walk through the results
SOP development to address identified gaps can be ordered separately.
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Sites preparing for an upcoming audit, onboarding to a new sponsor, or unsure whether their current SOPs hold up to current standards.
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Written report within 5 business days of document submission