Company presentation

1. 2015
COMPANY PRESENTATION

2. OPIS Spain - Avenida Diagonal 640 - Planta 6 - 08017 Barcelona
• Full service clinical research to
Pharma, Biotech, Medical device and
Neutraceutics
• Phase I-IV, observational studies
• Investigator initiated studies
• Local submission, project
management and monitoring
• Located in Barcelona
• An independent
subsidiary of OPIS srl

3. • Local services
• Centralized services
Integrated full service with added value
Overview of services

4. Local Services
Regulatory
Support in:
• Projects’ Lifecycle
• Early Development (Ph I-IIa)
• Ph IIb-III
• Ph IV and NIS
Expertise in:
• Submission
• Follow-up
• Authorisation
Start-Up
• Negotiations of contracts and
budgets
• Medical writing
• Feasibility
• Electronic Investigators Network
in a wide range of therapeutic
areas
• Site selection
• Training
• Documents management
Project Management
• Plan & Track the patient
recruitment
• Coordinate Monitoring Activities
• Staff Management
• Ensure proper treatment of all
study related data
• Act as SPOC for Sponsors
• Ensure streamlined
communication among parties
• Project execution in compliance
with all applicable requirements

5. Added Value
Cost
competitive
Project
Control
Quality
assurance
Risk
Management
Plan
Remote
Monitoring
In-house
clinical
IT team
Flexible business models

6. • Data management
• Biostatistics
• Document management
• PHV
• e-Clinical services
Provided by HQ Italy
Specialized
Departments
Centralised services

7. Added Value
OPIS Departments
Integrated, quality service from a
single -source
Improved timelines and
real-time reporting
Seamless project execution
Clinical
IT
Statistics
PHV
Data
Mgmt
SAS Progr.

8. e-Clinical Services
CLINICAL.NET Study
Portal
eCRF
Study Drug
Management e-Imaging
Protocol
Deviations
Adaptive Risk
Based Monitoring
ePatient Reported
Outcomes
Electronic Trial
Master File
eLearning
IVRS and IWRS
Web-based
Developed by
our in-house
IT team
e-clinical
support
or stand-alone
service
GCP and FDA 21 CFR Part 11 compliant

9. Clinical Trial Web Portal, Modules

10. Project Control
Streamlined
execution
Data
available in
real time
Strict
control/
study
progress
checks
Constant
support/
reporting
issues
Shared
information/
KPI
evaluation
All Activities
strictly monitored  ensure that contractual timelines and
requirements are met
 provide extrapolation and data query tools
for reporting to the Sponsor
 prevent issues relevant to timelines and
contractual requirements
 facilitate information sharing
 interact with the Sponsor for supplying
exports, reports, periodic status updates,
etc., as required
 identify potential interfaces with Sponsor’s
systems

11. OPIS collaborates with trusted partners:
• Central and Local laboratories
• Phase 1 units
• Institutions and associations
• Translation agencies

12. OPIS Headquarters and subsidiaries
• Company info
• Subsidiaries
• Milestones
• Turnover
• Therapeutic expertise
• Audits

13. OPIS is an international CRO with a leading position in Italy. We provide a wide range of
clinical and e-clinical services for Pharma, Biotech and Medical Device Industries
as well as Academic Institutions and Non-Profit Organizations
Company overview
Founded by
medical doctors
from the Pharma
Industry
16 years of
experience
€ 26m in sales
+250 people
More than 1000
studies managed
Qualified, fully
trained and
dedicated staff
Expertise in main
therapeutic areas
Commitment to
quality:
146 audits
2002-2014
9 subsidiaries
covering 28
countries

14. OPIS Locations
OPIS
HQ
OPIS Spain
OPIS
Germany
OPIS France
OPIS
Romania
OPIS
Poland
OPIS
Sweden
OPIS
UK
OPIS
Switzerland
OPIS
Belgium
Dedicated on-site staff
• Country Project Managers
• Submission Specialists
• CRA Network
9 European
subsidiaries

15. OPIS Milestones
ISO 27001
certification
e-Management of
protocol deviations,
SAE, study drug
1998 1999 2005 20082007 20142013 2014
1st contract
with big pharma
Establishment
of OPIS
ISO 9001
certification
Proprietary EDC
system validation
2001
Centralization
of services
(TSU and DOC)
2002
1st audit by
a big pharma
2003
1st clinical research
education courses
2010
e-clinical
study portal
European expansion with
subsidiaries in
UK, B, S, PL, RO
New
subsidiaries in
D, FR
Continuous innovation to support growth
2015
New
subsidiaries in
SE,CH

16. OPIS Evolution
0
5
10
15
20
25
30
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Millionin€
Years
Total Sales Net Sales

17. Other: Ophthalmology, Hepatology, Gastroenterology, Dermatology,
Musculoskeletal, Genetic Diseases, Infections and Infectious Diseases,
Psychiatry/Psychology, Vaccines, Urology, Gynecology, Nephrology,
Dental and Oral Health, Diagnostics, Endocrinology
Studies and Therapeutic areas
Breakdown: Therapeutic areas
(2007-2014)
939 Clinical trials
1
11,3%
29,6%
43,1%
7,5% 7,0%
1,5%
TRIAL DISTRIBUTION 2007-2014
Phase I Phase II Phase III Phase IV Observ. Med.Dev./Diet.Supp.
Oncology
29,7%
Hematology
12,8%
Cardiology/Vascular
diseases
6,4%
Neurology
6,3%
Pulmonary/Respiratory
diseases
5,6%
Immunology
4,8%
Rheumatology
4,6%
Metabolism
and nutrition
disorders
4,3%
OTHER
25,6%

18. Audits and Inspections
5
26
17
88
6 4
Due diligence System ISO Site FCCA Inspections
(Privacy, AIFA,
EMA)

19. «Evolving with you»
Evolucionamos contigo