The Clinical Research Unit has over 20 years of experience conducting clinical trials. It is located in Montreal, Canada and led by four principal investigators. The Unit has conducted over 325 trials across various phases and therapeutic areas. It has significant experience recruiting for and conducting vaccine trials, including being the highest recruiting site in Canada for GSK's H1N1 vaccine study. The Unit has a dedicated call center, state-of-the-art facilities, and capacity to enroll up to 100 subjects daily.

1. Clinical Research Unit
Capabilities Presentation
2020

2.  Founded in 2000 by Dr. Robert Bissonnette, MD, FRCPC
 20 years of clinical research experience
 Well established, high capacity clinical site in North America
 Located in a high concentrated population area; Montreal,
Canada
 Spearheaded by four principal
investigators with a rich research
experience
 Team of 40+ research employees
Introduction
2

3. Key Facts
Over 325
trials
conducted
Previous
experience with
conducting
trials in
vaccines
Multiple
indications:
H1N1, HPV,
Flu, Herpes
zoster, etc.
Highest
recruiting
Canadian site in
GSK's H1N1
vaccine study
Key Facts
Phase I -
8%
29%
36%
20%
NA - 4%
Cosmetic-…
Study Phases
Phas
e II
Phas
e III
Phas
e IV

4. Our Principal Investigators
Dr. Robert
BissonnetteFounder and Medical
Advisor
Dr. Carolyn Jack
Affiliated with CUSM
hospital
Dr. Catherine Maari
Affiliated with CHUM
Dr. Etienne St-Cyr
Affiliated with Cité-de-la
santé hospital

5.  Optimal work organization for study conduct; by function
 The study coordinator is at the center of all key tasks related to a study
 Collaborators focus on supporting the coordinator
CRU Work Organisation
5
Clinical
Study
Coordinato
r
Recruitment and
advertisement
specialists
Principal Investigators
and sub I’s
Ethic submission
coordinator
Data entry team
Sample processing lab
technicians
Photography and other
special procedures
experts

6. Recruitment
center and
research
database
• Site located in a large urban area, easy access to
healthy volunteers and COVID-19 infected patients
• Access to a large subject research database: nearly
68,000 research subjects / healthy volunteers
• Large database of patients on various systemic
immunomodulators (anti-TNF, anti-IL17, anti-IL23, anti
IL-4R, methotrexate, cyclosporine….) for sub-studies if
needed
• Dedicated call center to manage in-bound and out-
bound calls
• Phone pre-screening capabilities
• Team of 7 recruiters
6

7. State-of-the-art
clinical facility
• More than 15 exam rooms and 1 perfusion room
• High volume processing lab
• All required equipment for vaccine storage and
sample collection material
• Calibrated and supported by generators
freezers and refirgerators: -70C and -20C
freezers and 4C refrigerators
• Liquid nitrogen tanks
• Crash cart and emergency procedures required
for the management of First in Man trials
• Automated temperature monitoring system
7

8. Continuous monitoring system
• Temperature
• Humidity
• Refrigerator
• Freezer
Cloud-based
• Secured
• Real-time data
• Event and data history
• Reports and graphs
Alerts & communication
• Customizable setpoints
• SMS, phone and e-mail
Automated Temperature Monitoring System
8
Legend
In range
Inactive
Offline
Alarm
CRU plan

9. High Volume
• Capacity of up to 100 research subjects
daily
• 5 days/week, possibility of weekend
visits
• Use of central ethics board for fast study
approval

10. Vaccine experience
Patient population Indication Description Phase
Healthy Volunteers HPV HPV-16/18 L1 virus-like particles III
Healthy Volunteers HPV
HPV-16/18 safety follow up study following vaccine
administration
III
Healthy Volunteers HPV
HPV-16/18 Vaccine substudy-further testing subjects who
were either cervical cytology negative and oncogenic HPV
positive or pregnant at the end of main study
III
Healthy Volunteers Flu A/turkey/Turkey/1/05 II
Healthy Volunteers H1N1 GSK2340274A or with trivalent seasonal flu vaccine I
Psoriasis
Vaccine substudy in
psoriasis patients
Response of Adacel and Pneumovax vaccines in psoriasis
patients treated with ustekinumab
III
Psoriasis Herpes zoster Zostavax IV
Immunocompromised
patients
Herpes zoster V212 II

11. Well established, high capacity clinical site in North
America; Montreal, Canada
Dedicated call center
State-of-the-art facility
High volume
The Innovaderm Signature
Previous experience in conducting vaccine
trials: (9, including H1N1 vaccine study)