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Select Sites Faster: Feasibility Forms for Ops Using SASI & EHR Counts
A practical operations playbook for trial ops teams: apply SASI, EHR-derived patient counts, prefilled site profiles, and simple scoring to speed site...
P10/P50/P90 Forecasts That Pinpoint Site Bottlenecks in Clinical Trials
Practical operations guide to patient enrollment forecasting in clinical trials. Use P10/P50/P90 bands, regular updates, and site level fixes.
90 Day Pilot to Fix Regulatory Affairs Workflow Design for ICH and FDA
Run a 90 day pilot to rebuild regulatory affairs workflows to meet ICH and FDA. See where AI safely adds value, what governance is required, and HaiPhai's...
Inspection Ready FDA Audit Trails: Map Predicate Rules, Use Hash Chains
Make audit trails inspection ready under 21 CFR §11.10(e). Map records to predicate rules, keep append only logs, and use hash chained verifiers for...
Fix Clinical Protocol Governance: Link CtQs to RASCI, KPIs and AI
Make clinical protocol governance operational: map CtQs to RASCI roles, track KPIs, and use governed AI to speed compliant site activation.
Seven Stage SOP Change Control Mapped to ICH Q9 and Q10
Seven stage SOP change control mapped to ICH Q9 and Q10, with FDA filing checklists and governed automation to speed approvals for regulated teams.
8–12 Week Sprint to Inspection Readiness for QA and Regulatory Leaders
Implementation-first inspection readiness program for regulatory and QA leaders. Assign evidence owners, map records, run an 8 to 12 week pre-inspection...
Cut Clinical Site Activation to 90–120 Days for Clinical Operations
Operations-first, evidence-backed steps to compress clinical site activation to a 90–120 day target using task sequencing, KPI tracking, and automation.
90 Day eCTD Publishing Readiness: Organize Teams and Vendors
Practical operations-first checklist for eCTD publishing v4.0 readiness. Plan sequence architecture, assign owners, validate CVs, and run a vendor pilot.