End to End Workflow Discovery

• Ran interviews and workshops across Clinical Ops, Regulatory, QA, and Supply Chain
• Mapped existing As Is workflows, including informal handoffs and shadow processes
• Identified bottlenecks, rework loops, manual checks, and compliance risk points
• Documented dependencies between roles, approvals, and artifacts

As Is → To Be Process Redesign

• Simplified multi step workflows by removing redundant actions
• Defined a single source of truth for each workflow
• Resequenced steps to match real operational and regulatory logic
• Designed To Be flows that enforce the correct order by default

Guided Workflow UX

• Designed a structured, step by step flow that prevents skipping required steps
• Introduced a dynamic stepper to show progress, current state, and what’s next
• Used context aware forms to show only relevant inputs per role and step
• Reduced cognitive load and eliminated “wrong form / wrong time” errors

Automated Handoffs & Role-Based Routing

• Replaced email driven handoffs with system controlled task routing
• Defined role based ownership and permissions at each step
• Introduced mandatory digital sign off where required
• Ensured every transition created a traceable, timestamped record