OrioNex
KOMembership

ABOUT ORIONEX

Connecting expertise
to practical change.

OrioNex provides specialist consulting, training and process improvement solutions to strengthen clinical trial quality and operational efficiency.

EXPERIENCE INTO PRACTICE

Sanghee Kim

Principal Consultant, OrioNex · PhD in Pharmacoepidemiology

Sanghee has held leadership roles across clinical trial operations, data management, pharmacovigilance, RBQM and Central Monitoring in pharmaceutical companies and a global CRO. Through OrioNex, she provides practical consulting and training. She also teaches Clinical Trial Management as an adjunct professor in the Department of Pharmaceutical Industry at Sungkyunkwan University.

OUR PRINCIPLES

What guides our work

Insight to Impact — turning insight into practical change through RBQM and workflow automation. The ai in orionex-ai.com stands for Automation & Impact.

01

Proportionate

Match the scope to critical risks and the organisation’s actual needs.

02

Connected

Connect roles and information across Clinical Operations, DM, Medical, PV and Quality.

03

Practical

Design procedures, tools and deliverables that teams can use.

04

Sustainable

Strengthen human judgment and capability for lasting improvement.

OUR APPROACH

How we work

We start by defining the problem and intended outcome together, then choose the approach and tools.

01

Diagnose

Understand current processes, data flows and the issues teams experience.

02

Design

Define the scope and operating model around critical needs and real constraints.

03

Implement

Apply agreed processes and tools, and verify them against intended use.

04

Enable

Build the skills and ownership needed to operate and improve independently.

LET’S MOVE FORWARD

Turn today’s challenge
into your next action.

Start a conversation

ORIONEX MEMBERSHIP

About membership

Register using email verification and save readiness results to your account. Saved reports can be downloaded or deleted in your member account.

You can use the basic RBQM readiness check now without registration.

Start the basic checkAsk about resources

Privacy and use of this site

The basic check is calculated in your browser. Profiles and readiness responses you choose to save are stored in your member account. Unsaved answers are lost on reload. Enquiry form entries are not stored on a server. Your language preference may be stored in this browser. If you choose to discuss your results, their summary is temporarily held in this browser session to populate the enquiry page and is deleted when read there. If you send an enquiry email, its contents are delivered to OrioNex for handling your request. Member authentication and storage use the Supabase Seoul project; verification emails use the Resend Tokyo sending region. Profile information is retained during member service use and deleted when withdrawal or deletion requests are processed. Marketing consent is optional and can be changed in your account. Read the detailed notice on the membership page. For privacy enquiries, contact contact@orionex-ai.com.

Use of this site

The readiness check is an OrioNex educational and improvement tool. It does not replace a regulatory compliance determination, audit or certification. Decisions for actual clinical trials require review of trial-specific risks and applicable requirements.