1. Improvement of Quality and Efficiency by
Early Phase Integrated Clinical Automation Solution
Thanks for kind introduction. As he introduced, I’m a clinical pharmacologist and an operational manager of clinical trial center of Seoul National University Hospital in South Korea. Now, I’m a project leader of the new clinical trial automation system of our center. I’m very proud the I have an opportunity to present my experiences in 2016 KoNECT international conference.
Today’s topic is Improvement of Quality and Efficiency by Early Phase Integrated Clinical Automation Solution.
SeungHwan Lee, M.D., Ph.D.
Clinical Trials Center & Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital

2. Seoul National University Hospital Clinical Trials Center
Many of the audiences don’t know my hospital and clinical trials center, so firstly I’ll give brief introduction about Seoul National University Hospital and Clinical Trials Center.
SNUH is an oldest and top-ranked hospital in South Korea, and consist of 4 big hospitals and 1 health care center. It has a total of about 4000 beds.
SNUH has many research facilities focused on basic, translational and clinical research including clinical trials center.
The clinical trials center consists of Main clinical trial center and Cancer clinical trials center and Pediatric clinical trials unit.

3. Seoul National University Hospital Clinical Trials Center
SNUH CTC facilities
Research ward
Established in 1995
Cancer CTC in 2011
Pediatric CTU in 2012
Core lab.
Outpatient clinic
Designated as the Regional Clinical Trials Center by the MOHW in 2004
Designated as the Global Center of Excellence in Early Clinical Trials, SNUH (GREATS) by the MOHW in 2012
Pharmacy
Pharmacodynamics lab.

4. Seoul National University Hospital Clinical Trials Center
Clinical Trials in SNUH
Phase I trials in SNUH
The number of clinical trials conducted in SNUH is increasing rapidly and about 250 clinical trails including 51 phase 1 study were conducted last year. Among 51 phase 1 studies, about the half is oncologic study, and the other half is various clinical pharmacology studies including first-in-human study.

5. GREATS
Global Center of Excellence in Early Clinical Trials, SNUH (GREATS)
Mission
Through state-of-the-art clinical trials, we create knowledge that changes the standard of care to improve human health around the globe
Vision2022
The world's leading early clinical trials center
By promoting Quality and Efficiency of early clinical trials
From this slide I’ll present why and how we adopt the new clinical trial automation system.
Our center was designated by GREATS, Global center of excellence in early clinical trials by Korean Government in 2012.
The mission of GREATS is Through state-of-the-art clinical trials, we create knowledge that changes the standard of care to improve human health around the globe.
And the vision2022 for the mission is to be the world’s leading early clinical trials center by promoting Quality and Efficiency.

6. Quality & Efficiency of Early Clinical Trials
In Science, Ethics & Data management
By Improving Facilities & Systems
Excellent
End-data
Quality
Convenience for Researchers
Global Standard Conformance
According to the mission and vision of GREATS, we are trying to achieve the quality and efficiency of early clinical trials in Science, Ethics and Data management by improving facilities and systems.
And the final goals of quality and efficiency are excellent end-data quality, convenience for researchers and global standard conformance.

7. Re-evaluation of Trial Process
Collection
Reception
Processing
Storage
Transport
Discard
Drug Administration
AE Reporting
Measurement
PK Sampling
Test
Data Entry
Source Paper Management
Termination Visits
CSR
Contract
Protocol Dev.
CRF Dev.
Initiation Visits
Consent
Recruitment
Screening & Enrollment
Randomization
Pre-study Management
Study Initiation
Subject Management
Data & Doc. Management
Sample Management
Study Conduction
Quality Management
Administrative Support
Monitoring & Audit
Study
Termination
Post-study Management
Exterior Lab
Sample Flow
Iterative Process
Data Flow
To decide what and how we improve the quality and efficiency, firstly we re-evaluated the study process of our center. Our process coincides with regulations and various guidance about early phase studies and goes well, but some matters were still exist.

8. Requirements for Quality & Efficiency
Now
(weak points)
Paper-based Process
Repetitive works (copy, dual enter…)
Paper Monitoring
Source and CRF management issue
Difficulty of fully integration with EMR
Depend on Personal Ability
Human Error
Sample Management
IP Management
Future
(Requirements)
Excellent End-data Quality
Two way approach
(automated & paper based)
Real-time data capturing
Paperless process
Refinement of sample management
Refinement of IP management
Convenience for Researchers
Global Standard Conformance
The first problem is many of the process are based on the paper documents.
Due to the paper-based work, many works are conducted unnecessarily repetitive, including copy, data entry.
Also, most of the data monitoring process are conducted in the center, not remotely, some sponsors claim the inefficiency and inconvenience in data monitoring process.
Also the source and CRF management issues and difficulties in the integration with EMR are also raised.
The Second problem is the most of the process depends on personal ability. So, risk of human errors are always exposed in data collection, sample management, and IP management.

9. Identification via barcode
Current 2
Identification via barcode
Investigator
CRN 3
Subject
Worksheet
Scale Device 1
Patient Monitor
VS, ECG…
Protocol and e-CRF Design
Paper Sources
Handwriting 4 6
Data Entry
Paper-based Sample Tracking
This diagram shows the past and current process of our center. As I mentioned, the data are manually produced and recorded on the paper source documents, and entered in EDC system by manually.
EDC Software
(Promasys®)
Handwriting 5
Data in EMR
Print/Copy

10. Current
Paper CRF
e-CRF

11. Requirements for Quality & Efficiency
Now
(weak points)
Paper-based Process
Repetitive works (copy, dual enter…)
Paper Monitoring
Source and CRF management issue
Difficulty of fully integration with EMR
Depend on Personal Ability
Human Error
Sample Management
IP Management
Future
(Requirements)
Excellent End-data Quality
Two way approach
(automated & paper based)
Real-time data capturing
Paperless process
Refinement of sample management
Refinement of IP management
Convenience for Researchers
Global Standard Conformance
After recognizing the problems, we established the final goals of our process improvement.
The first goal is excellence in end-data quality. To achieve this, we decide to adopt a new automation system in addition to paper based system.
The automated system includes real-time data capturing, paperless process, refinement of sample and IP management.
The other goals are convenience for researchers and global standard conformance.

12. Goal
Automation System
Study Design, Schedule and Resource Assignment
Patient Monitor
VS, ECG…
Investigator
CRN
Subject
Identification via barcode
System-based Sample Tracking
Direct Capture 1 2
Automatic Transmission 3
Scale Device
Data in EMR
The diagram present the target improved process of our center. All data are directly capture from medical devices or EMR without manual work.

13. Investigational Product Management System
IT systems
Early Phase Integrated Clinical Automation Solution (EPICS)
Clinical Trial Process Automation
Investigational Product Management System
IP Management
Based on this plan, we adopted three IT systems.
CTCin
Clinical Trials Center Management

14. Plan for Clinical Trial Process Automation
Recruiting
Screening
Ward
Sample Tracking
PK Lab
Medical Coding
Monitoring
Data Management
Recruitment
Website &
Mobile Apps
Subject Information
Trial Advertisement
Direct
Capture
Subject
Identification
PK Sample
Identification
Patient
Monitor
Study Conduction
in the Ward
EMR of SNUH
Lab Result
(HL7)
Auto-sensing and file import
Wireless
Direct
Capture
Tablet
or Laptop
This diagram shows the EPICS system. The system is operated by tablets or labtops for the investigators convenience. All data are directly captured from various medical devices without manual records on the paper source document, and the data in EMR including lab data are automatically sensed and imported. Also the system auto-communicates with recruit website.
Data
Extraction
e-Source Management
(Not need paper source)
Variable Industry Standard Data Format Support

15. Easy Access System Direct capture to clinical trial DB
Auto-transmission from EMR
Remote monitoring through external access
Application Server DB
Server
Reporting Server
DMZ Zone
SNUH EMR Server
GE Dash 5000
Patient Monitor
Barcode Reader
SNUH System
TrialOne® System
Instrument
User
SNUH CTC
External
Wireless
Internet
Connect
From this slide, I’ll show details of EPICS.
This system can access from internal network and external network. So employers of pharmaceutical company and CRO as well as CTC staffs can access this system easily.

16. Easy Access System
Also this system is operated by tablet or laptops, therefore data production and entry can conduct anywhere.

17. Website for Subject Recruitment
Build a new website for recruitment
Four language (Korean, English, Chinese, Japanese)
Auto-communication between website and clinical trial DB
Data filled in website is transferred and archived in DB automatically
Easy data sorting and filtering
We built a new recruitment web site with 4 language, which can communicate automatically with EPICS. All data collected from website automatically archived in EPICS system

18. Website for Subject Recruitment
This is the domain name and the main page of the recruitment website. As I mentioned, when the volunteer filled the data, the data automatically transferred and archived in TrialOne.

19. Website for Subject Recruitment
Expansion of SNUHCTC’s subject pool
Healthy volunteers
876
3664
Total 4540
Korean
Gender
Age
(2016.6)
This system helps easy volunteer management, enlarge the volunteer pool up to 6,000.
Patients

20. Subject & Sample Management
Bar-code system
All subjects and samples are managed and tracked by bar-code

21. Device Integration
The pictures are the data transfer of patient monitor and the transferred results.

22. Automatic Data Integration with EMR
New interface link clinical trial DB to EMR
Automatic data import from EMR (3 times/day)
EMR of SNUH
TrialOne
Order
Import

23. Automatic Data Integration with EMR

24. IPMS Radio-Frequency Identification based IP Management System
RFID Tag
(Include IP information including IP number, Expiration date)
Prescription 2D Barcode

25. IPMS
Workflow using IPMS

26. in case of Matching Error
IPMS
Prevention Human Error
Pop-up Alert
in case of Matching Error
IP Tracking

27. CTCin
Research schedule management

28. CTCin
Research ward management

29. CTCin
Outpatient Clinic Management

30. CTCin
Device Management

31. THANK YOU FOR YOUR ATTENTION!!!