This document summarizes the location and facilities of AXIS Clinicals, a clinical research organization located in Dilworth, Minnesota near Fargo, North Dakota. The facility has 180 beds across 3 study units and can dose up to 1,000 subjects per month. It has 10 LC-MS/MS machines, 15,000 samples/month analysis capacity, and 120,000 square feet. AXIS Clinicals uses various hardware like Microsoft Surfaces, desktops, and medical devices from different vendors for electronic data capture in areas like screening, studies, and specified devices. Foundry Health's flexibility allowed them to interface existing equipment for eSource data collection.

2. Where are we from?
• AXIS Clinicals is
located in Dilworth,
MN.
• Approximately 3
miles east of
Fargo, ND

3. - The Greater Fargo Moorhead area includes a population
of approximately 220,000 people.
- Diverse population of student and non-student
volunteers.
- 25,000 + college aged students in 3 local campuses.
- Yes… Winters are cold up there.
- No… We don’t all talk like the movie/TV show “Fargo”
Characteristics of our Community

4. 10 LC-MS/MS
Machines
15,000 samples/month
analysis capacity
Method Development
& Validation
180 Beds
3 Study Units
Dose up to
1000 subjects/month;
180 subjects/study
Dedicated 6000 sq ft
Dermatology Center
Strategic Partner Site in
Miami, FL for Dermatology
studies requiring second
climatic zone
120,000 sq ft
purpose-built facility
Successful FDA Audit
June & Aug 2017
Verified Clinical Trials
member
DEA License for
controlled substances
A Promise to Precision in Clinical Trials
Clinical
Bioanalytical
Project
Management
Medical
Writing
Screening
&
Recruiting
IRB
Submission
Quality
Assurance

5. Focus on eSource data collection
• AXIS Clinicals USA started working toward eSource data
collection when I started in November of 2013.
• We began vendor audits in early 2014, and decided on an
eSource platform in summer of 2014.
• As a result AXIS Clinicals purchased several pieces of
equipment at that time with the anticipation of going live with
limited paper source. Unfortunately, there were problems
resulting in the termination of our original eSource contract.
• AXIS Clinicals was now in possession of multiple pieces of
equipment that were not being used (e.g., multiple Microsoft
Surface Pro 3 units, scanners, label printers, etc.).

6. Hardware Choices/Form Factors
• As we had already made some major investments into
equipment, our choices were a bit limited.
• Thankfully, the flexibility of eSource programming at
Foundry Health (and, more specifically, the flexibility of
Foundry Health Staff), allowed us to make use of existing
equipment.

7. Screening Hardware/Devices
- Screening Front
Desk
- Standard
desktop with
Integrated
Web Cam

8. Screening Hardware/Devices
- Medical History
- Standard
Double
Screen
Desktop with
integrated
bluetooth
scanner and
vitals

9. Screening Hardware/Devices
- HT/WT/BMI
- Wall
Mounted
Desktop Mini
connected to
Seca Scale
and
Stadiometer

10. Screening Hardware/Devices
- ECG
- Microsoft
Surface
mounted to
Mortara Eli
280 ECG

11. Screening Hardware/Devices
- Phlebotomy
- Desktop with
integrated
Bluetooth
scanner and
label printers

12. Screening Hardware/Devices
- Physical Exam
Room
- Desktop
integrated
with
Bluetooth
scanner
(optional use
of Microsoft
Surface)

13. Study Hardware/Devices
- Check-in
- Microsoft surface
with wired
scanner and
detachable
keyboard

14. Study Hardware/Devices
- Study Suite
- Standard laptop
with connection
to label printers
and ink-jet
printer

15. Study Hardware/Devices
- GE V100 Dynamap
- Microsoft Surface
connected via
USB splitter to
scanner and
Dynamap

16. Study Hardware/Devices
- Study Suite
Phlebotomy
- Microsoft Surface
connected to
wired scanner

17. Specified Devices
- Konica Minolta
CR-400
Chromameter
- Stand alone unit
with data
processor

18. Specified Devices with Interface
- Konica Minolta
CR-400
Chromameter
- Data processor
connected
directly with
computer (Thank
you Brock for the
ability to
download J)

19. Portability
- Cell phone
- ClinSpark is a Web
Based platform
allowing review (or
even entry) of data with
any smart phone.

20. Hardware/Med.Device Overview
• The ability of Foundry Health to work with our existing
equipment (Microsoft Surface, Seca Scales, Mortara Eli
280, V100 Dynamap, and CR-400 Chromameters) has
allowed AXIS Clinicals to capitalize on our previous
medical device investments instead of purchasing
additional equipment.
• The customer service of Foundry Health has been
outstanding in trouble shooting data collection barriers
and creating seamless interfaces with existing
equipment.

21. Things to think about:
• Clocks and timers – Devices that are not synchronized
with atomic clock may cause errors.
• Equipment Forms – portable vs stationary
• Connectivity – invoke data, “push/pull” data, etc.
• Bluetooth Scanners – may take time to connect to
equipment. Bluetooth scanners need to be charged.
Wired scanners have fewer points of failure (as of now).
• Touchscreen vs. Keyboard – Need to determine amount
of typing required for data collection.

22. Questions?