CRO/SMO tacit knowledge

Extract, standardize, and formalize successful setup patterns through AI conversations so they can be handed over to new owners

Background and Challenges

Reliance on verbal handoffs from experienced staff and individual notes causes information to be scattered and frequently lost

The cost for each person to learn the differences between facilities is high

The know-how for launching operations is highly dependent on individual expertise, creating significant risk when ownership changes

Long setup periods are delaying the start of clinical trials

AS-IS (Conventional Approach)

・Information is fragmented due to reliance on verbal handoffs and notes

・High learning cost for each facility

・Trial start delays caused by launch delays

TO-BE (After Implementation)

・Consolidate all expertise through asynchronous collection

・Automatically structure success and failure factors

・Automatically generate facility-specific procedures

Operational Flow

1. Send interview URLs to all stakeholders at once

2. AI extracts know-how and risks from the responses

3. Generate procedure manuals optimized for each facility type

4. New owners refer to the materials and complete setup quickly

Information That Can Be Collected

・Facility-specific requirements and feature list

・Key considerations in the approval process

・Risk checklist

Implementation Impact (KPI)

・Setup period: -40%

・Rework instances: Significantly reduced

・Process compliance rate: Improved