New TTI 31MAI2016 General

Knowledge Experience Control Results

Chief Executive Officer Douglas Andreas Valverde

31-Mar-2016

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

Techtrials Business Units

TECHTRIALS

TTI CRO

TTI US

TTI Outsorcing

Commitment, Flexibility and Speed

TTI CRO Clinical Trials Operational

Services (Brazil)

TTI US Functional

Service Provider (USA)

TTI Outsourcing Contractors for the Healthcare Industry

(*) TTI = Techtrials International

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

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

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

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

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

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

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)

Experience

Techtrials has grown consistently as illustrated below:

2010 2011 2012 2013 2014

FaseI

FaseII

FaseIII

FaseIV

BEQ

OBS

HEOR

EAP

Invitro

N of studies started / year

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)

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.

Affiliations

ANVISA – Registered as CRO

ABRACRO (Brazilian Association of CROs) –

Member

ABRACRO Member

Operation and Facilities

Located at Centro Profissional Morumbi Shopping with all admin and logistics support

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

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

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;

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

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

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

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

02 03

04

Bioequivalence

First CRO in Brazil to offer BEQ PM and Monitoring in tegrat ing c l in ica l 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

02 03

04

Image: Bryan Christie

Advance your trials using patient-

generated data

carenet L O N G E V I T Y

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

This is where consumers now get their digital

health solutions from. carenetL O N G E V I T Y

The global wearable

tech market is expanding

quickly.

433 different 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

Today we show you how to explore this new resource and begin the

transition.


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.


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.


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:


1.  Subject recruitment 2.  Remote patient monitoring during studies 3.  Post marketing research 4.  Patient communities

Benefits


One simple connection to access a whole new universe

of mobile health data.


Carenet Just plug it in

Trial System carenetL O N G E V I T Y

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


+100

Wearables

Apps

Devices

Integration Biggest mobile health data

integrator in LATAM.


Thousands of lives monitored and

constantly adding more users to the platform.

Monitoring


Algorithms

Apps

Codifying medical knowledge.

Portfolio of engagement tools and digital communication channels.

Guidance


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

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

Differentiators

Responsiveness Quality Cost

Prompt answers

Efficient process & procedures

Metrics/Milestones

Patient safety

Open dialogue

Negotiation

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

Techtrials provides safety for your

project and outsourcing model.

Contact Information

United States Art Ziegler Executive Vice President – North America Flemington, New Jersey United States Tel: 908.547.7447 E-mail: [email protected] 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: [email protected] Skype: douglas.andreas.valverde

New TTI 31MAI2016 General

Documents

Transcript of New TTI 31MAI2016 General