Source Document Creation & Management
Protocol-specific source templates, eSource implementation, and ongoing documentation oversight that holds up to monitor and inspector scrutiny.
What we offer
Services tailored for research sites
From source documentation to inspection readiness, our advisory services cover every operational and compliance touchpoint of a high-performing research site.
Audit Preparation & Inspection Readiness
Mock FDA inspections, sponsor audit prep, document remediation, and CAPA development to ensure inspection-ready operations year-round.
Quality Control & Process Improvement
Site-wide QC programs, root cause analysis, Lean process redesign, and KPI dashboards that drive measurable quality outcomes.
Budget Development & Financial Oversight
Sponsor budget negotiation, true-cost analysis, invoiceable visit tracking, and revenue recovery for missed milestones.
Staff Training & SOP Development
ICH-GCP refreshers, role-based onboarding programs, and a complete library of customized standard operating procedures.
Site Feasibility & Study Start-Up
Feasibility assessments, regulatory packet preparation, IRB submissions, and contract review to accelerate activation.
Protocol Deviation & CAPA Management
Structured deviation review, trend analysis, and corrective/preventive action plans aligned with sponsor expectations.
Regulatory Binder & TMF Oversight
Investigator site file builds, eTMF reconciliation, and routine binder QC to keep regulatory records inspection-ready.
Not sure where to start?
Every engagement begins with a complimentary discovery call to understand your site's priorities and goals.
Start the conversation