2. Timeline
Douglas Valverde founded
TECHTRIALS Brasil.
(CRO)
2009
Consolidation in the Brazilian
Market and increase in clients
database
TECHTRIALS
INTERNATIONAL expansion
in North America (USA)
1Q 2014
Outsorcing
3Q 2014
Outsourcing Business Unit
4. Organization Chart – Brazil
Chief Executive
Officer (DV)
HUMAN RESOURCES,
FINANCE AND
ADMINISTRATIVE AREA
Finance/Admin
Analist (RM)
BUSINESS
DEVELOPMENT AREA
BD Manager
(AC/SB)
Exec VP
BD Latam
OPERATIONS AND
QUALITY ASSURANCE
AREA
Clinical Op & QA
Director(CM)
CLINICAL OPERATIONS
AREA
CPMs Team (Allocated In-house
OR at client)
CRAs Team (Allocated in-house
OR at client)
CTA & other admin. Team
(Allocated In-House OR at client)
QUALITY ASSURANCE
AREA
In House Staff (CPMs and CRAs)
designated by Clinical Op & QA
Director (CM)
BIOEQUIVALENCE
AREA
BEQ Head (CS)
Versio 1.0 dated 24/Feb/2016
5. Techtrials US Operations
www.ttrials.com
Art Ziegler
Executive Vice President
North America
Douglas Valverde
Chief Executive Officer
Marise Gomes
MD MHS PhD
Chief Medical Officer
6. Knowledge
Techtrials Clinical Research Professionals
1
2
3
4
Carefully selected professionals
Up to date CV database
Professional Network Search Engines as LinkedIn
Clinical Research Networking
7. Team Experience
Collectively our team has solid research
experience, including management of complex
projects:
• Experience: over 200 years
• Trials: over 300 research projects
• Geography: management of LA region as a whole
Operation of 29 studies/clinical trials since 2010
• Large studies with 10 and more sites participation
• Studies with 5-10 sites participation
• Studies (Phase III – Rhinitis) with more than 500 patients
included
• Studies with Regulatory activities responsibility (CEP /
CONEP / ANVISA)
• Studies with Project management responsibilities
• Studies with Monitoring activities responsibilities
8. Sustainable Growth
Techtrials has recorded +59% growth in revenues (CAGR 5Y)
Evolution of Revenues R$ (since start up)
2009 2010 2011 2012 2013 2014 2015
9. Experience
Clinical research projects Phase I to IV
and Beq studies
Feasibility capabilities – huge Site/
Investigator database and network
Interaction with more than 200 sites in
different therapeutic areas
All therapeutic areas such as
Cardiovascular, Oncology, Urology,
Respiratory, Infectious diseases,
Vaccines, Gastroenterology, etc
10. Experience
Operation of 29 studies/
clinical trials since 2010.
Collectively our team has
more than 200 years of
clinical research experience.
Our team has participated in
more than 300 clinical research
projects.
Number of Projects/Signed Contracts vs. time (2010 to 2015)
11. Experience
Techtrials has grown consistently as illustrated below:
2010 2011 2012 2013 2014
Fase I
Fase II
Fase III
Fase IV
BEQ
OBS
HEOR
EAP
In vitro
N of studies started / year
12. Experience
Techtrials experience acquired, considering Number of studies
per Therapeutic area and per Type of study
Fase I Fase II Fase III Fase IV OBS HEOR EAP
Respiratory (Asthma,
Rhinitis, Allergy)
Oncology (Brain,
Hematho, Prostate)
Cardiology
Neurology (Cephalea,
Insomnia)
Vaccines
Others (Gastro, Uro,
Gyneco)
13. Strategic Focus
Core Services
Outsourcing, Co-sourcing
(Contractors);
Project Management;
Monitoring;
Regulatory Affairs;
BEQ PM and Monitoring –
Analytical and Clinical;
Medical Services Management -
Protocol Writing, Epidemiology,
Pharmacoeconomics (HEOR),
Market Access. Biostatistics;
Drug Development Strategy.
17. Processes
All employees are subject to training plan/records according to
Training SOP, and subject to qualification analysis prior to hiring;
SOPs in place (33), revised every 2 years or
prior than that when needed
Disaster Recovery Plan SOP in place
Techtrials already audited for qualification to be a
clinical research service provider = Approved
Quality procedures according to Quality
Control and Audit SOP
18. Contract and Pricing
Open negotiation for pricing to make your
project feasible;
Easy contract procedures – Fast
contract analysis and signature;
Budgeting/pricing usually done via
turn key analysis/model;
Unit pricing also possible and already
used in some current contracts;
Study pricing tool developed in-house
19. Global Reach
Brazil (São Paulo) and USA (New Jersey) operations;
Partnerships with other CROs currently covering Argentina, Canada,
Chile, Australia, India, New Zealand, Mexico, Colombia;
20. IT Structure
File Server:
Data Center Tier 3 category located in Brazil, which ensures high availability (99.9%),
excellent performance with low latency to access files, security against political
espionage from other countries, accessibility to higher volume of migration data and
with the robustness to deliver a quality service monitored 24x7x365, with reliability,
flexibility and scalability;
Notebooks core i3/ 3GB or better
Exclusive WLAN
IT Support and Planning contracted, provided by Penso
(company that also provide services to Petrobras, Rede Globo
and other major companies);
01
02
03
04
21. Project Management
We also have Six Sigma certified/experienced
project managers;
PMs using CTMS;
PM using Microsoft Project specifically for BEQ studies
since BEQ studies are like accelerated clinical trials and
we do not have enough time to implement regular CTMS
strategy;
Our project managers are all very experienced
CR professionals;
01
02
03
04
22. Outsourcing Business Unit
The professional may be in company, home-office or at our office;
Fast hiring scheme, minimizing labor risks;
Benefits compatible with your company offers to other employees (mobile
phones, company credit cards, meals, health insurance, life insurance, etc.);
Admission and resignation process done in our company;
Performance management (360 degrees evaluation) and replacement of
professionals when necessary;
Ongoing relationship with the client;
Techtrials has been contracted by several Multinational Pharma Companies for
this model, since 2010. Currently working with 5.
01
02
03
04
05
06
07
23. Product Intelligence & Strategy
Techtrials provides services and support related to Intelligence & Strategy of
pharmaceutical product development, such as:
Analysis of the client case to
define the best strategy for the
product
Identify the specific studies and
procedures steps that are
required for new products registry
or product registry renewal
Support to the client on following-
up with ANVISA through meetings
and discussions, providing
assistance on presentations, if
needed
Providing all information about
the operational steps and
prices of all required activities
related to the project (planning,
timelines, costs)
01
0203
04
24. Bioequivalence
First CRO in Brazil to offer
BEQ PM and Monitoring
integrating clinical and
analytical phase
SOPs already implemented
and integrated with other
Techtrials SOPs
Techtrials already audited
and qualified to operate as
BEQ service provider by
s e v e r a l M u l t i n a t i o n a l
Pharmas
BEQ Head and Project
Manager with more than 80
projects already executed
01
0203
04
26. Consumers’ use of apps
and wearables has doubled
in the past two years.
Source: Accenture 2016 Consumer Survey on Patient
Engagement (across 7 countries, including Brazil)
carenetL O N G E V I T Y
27. This is where consumers
now get their digital
health solutions from.
carenetL O N G E V I T Y
28. The global
wearable
tech market
is expanding
quickly.
433different types of devices
available as of today.
Lifestyle 251
Pet Animals
Fitness 194
Entertainment
Gaming
Industrial
Medical 76
Source: Wearable Technology Database, Vandrico Inc.
carenetL O N G E V I T Y
29. Today we
show you how
to explore this
new resource
and begin the
transition.
carenetL O N G E V I T Y
30. Treasure
trove of data
By arming participants with
wearables and FDA Class II
medical devices, sensors
and mobile applications,
pharmaceutical companies
can remotely collect data,
along with key biometrics.
carenetL O N G E V I T Y
31. Example Pulse
Fitness and Prevention
Fitness trackers like the Fitbit
Charge HR use light sensitive
photodiodes to capture the
heart rate.
Example Diabetes
Health
Sensors like the Kenzen
Smart Patch determine the
blood glucose concentration
in the subcutaneous tissue.
Example Steps
Wellness
Smartphone Apps like
All4One or Longevidade use
sensors and geolocation to
monitor steps and calories
burnt.
carenetL O N G E V I T Y
32. Digital health solutions allow
companies to bring a drug to
market more efficiently and
cost effectively, while also
improving the clinical trial
participants’ experience by
decreasing the number of in-
person visits and the need
for manual tracking of data.
This all
stands to
significantly
restructure
the drug
development
process:
carenetL O N G E V I T Y
33. 1. Subject recruitment
2. Remote patient monitoring during studies
3. Post marketing research
4. Patient communities
Benefits
carenetL O N G E V I T Y
34. One simple connection to
access a whole new universe
of mobile health data.
carenetL O N G E V I T Y
36. Integration Monitoring Personalization Guidance
Applications + APIs
Wearables + IoT
Healthcare devices Monitoring and
visualization in
real time.
Cloud computing
• Challenges
• Community
• Gamification
• Decision support
• Behavior
modification
• Customized
services
Codification of
knowledge +
Use of mobile health
algorithms.
= Personalization
1. 3.2.
PHR
Lab Results
4.
The way the platform works
carenetL O N G E V I T Y
40. Conclusion
Digital health platforms, such as Carenet, are
enabling the easy integration of data from dozens
of digital health sources to advance your trials.
carenetL O N G E V I T Y
41. Leading Brazilian CRO
Leading Brazilian CRO due to
Successfully audited and rated (eg. D&B).
High quality research and outsourcing services
Exponential growth: + 59% (CAGR 5Y)
Preferred vendor of big pharma companies
01
02
03
04
43. Results
Leading Brazilian CRO due to:
Successfully audited and rated (eg. D&B)
High quality research and outsourcing services
Exponential growth: + 59% (CAGR 5Y)
Preferred vendor of big pharma companies
46. Contact Information
United States
Art Ziegler
Executive Vice President – North America
Flemington, New Jersey
United States
Tel: 908.547.7447
E-mail: art.ziegler@ttrials.com
Skype: art.ziegler7
Latin America - Brazil
Douglas Andreas Valverde
President and Chief Executive Officer
Avenida Roque Petroni Jr. 1089 - 3rd floor – Un 311
Edificio Centro Profissional Morumbi Shopping
CEP: 04707-900 | São Paulo-SP | Brasil
Tel: +55 11 3033-9740
Cell: +55 11 97048-1000
E-mail: doug.valverde@ttrials.com
Skype: douglas.andreas.valverde
