E6R3 SOP Starter Pack
Eight core SOPs. Built to standard. Tailored to your site.
The foundational set of SOPs every clinical research site needs — pre-built to ICH E6R3 standards and customized to your workflows before delivery. These aren't templates to edit; they're finished documents ready to implement.
After your order, we schedule a 30-minute intake call to collect your site-specific details. SOPs are delivered as editable Word documents within 7–10 business days.
-
Informed Consent Process
Source Document Standards & Verification
Protocol Deviation Management & Reporting
Investigational Product Handling & Accountability
Trial Master File Maintenance
Adverse Event Identification & Reporting
Staff Training & Qualification Documentation
Audit Preparation & Inspection Readiness
-
Sites building their quality infrastructure from scratch, coming off a gap assessment, or replacing outdated SOPs ahead of an inspection.
-
7–10 business days after intake call.