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  • All rights reserved. Confidential.

    Group Presentation

  • A UNIQUE INTEGRATED MODEL

  • The Evidence Generation Partner

  • We observe and interact with people for better health.

    We measure, record and analyze people body data’s and health dynamics to deliver valuable and trusted research outcomes and real world evidence.

    We believe in delivering effective and tangible solutions, innovation, products and brands worldwide through a network of research centres, dedicated resources and digitally enabled capabilities.

    Our consumer centric approach is supported by two research platforms: we design and implement protocols for outcome & clinical research, to collect insights, to understand health dynamics, to build science and to support claims.

    Our mission

    Emmanuel Pauze Managing Partner

  • Pivotal Research Capabilities #2 Platforms

    Safety & toxicology evaluation

    Non-human Efficacy testing

    Human Efficacy & performance trial

    Opinion leader

    Healthcare professional

    Consumer - patient

    Consumer health and lifestyle real-life

    dynamics

    Health trends and health economic

    Healthcare professionist attitude

    dynamics

    Consumer - patient

    Healthcare professional

    Opinion leader

    HOW I BELIEVE MYSELF

    HOW YOU ARE

    HOW YOU INTERACT, HOW YOU

    LIVE EXPERIENCE AND ADHERE

    WITH SOLUTIONS

    HOW TO BE SURE ABOUT SAFETY

    HOW THE SOLUTION IS A

    GOOD CANDIDATE

    HOW THE SOLUTION IS

    INTERACTING WITH HEALTH AND

    IMPROVING QUALITY OF LIFE

    Observational and epidemiological study

    Survey and consumer testing

    Burden of disease impact study

    Product economic and utilization analysis

    KOL service consulting

    Clinical trial

    Preclinical trial

    Safety and surveillance

    Post-marketing

  • Designing observational researches, we help to understand people phenotype and dynamics

    towards health borders, health influencers, product and brand environment.

    Using rigorous research methodologies we observe people, to identify:

    Outcome platform

    the relation and experience with

    health or disease;

    the relation with healthcare

    professionals;

    the dynamics related to an

    innovation, a product or a brand.

    - Survey and observational study

    - Health interview survey

    - Real-life evaluation and data collection

    - Health Reported Outcomes:

    - patient reported outcome (PRO) - observer reported outcome (ObsRO)

    - Quality-of-life assessment

    - Self-perception assessment

    - Consumer testing

    - Health Preference Assessment

    - Treatment patterns analysis:

    -product/medication adherence, persistence and compliance; - product/treatment switching, augmentation, and discontinuation; - product/outcomes associated with such measures

    - Burden of disease impact study - disease incidence and prevalence

    - health economic data extrapolation

    - disease/treatment cost analysis

    - healthcare resource utilization

    - systematic review and meta-analysis

    - Product Economic Analyses - cost analyses

    - price recommendations

    - Health influencers survey

    - Treatment patterns, impact and adherence

    - Product/drug utilization studies

    - KOL service consulting

    - Health Reported Outcome: - clinician-reported outcome (ClinRO)

    - performance outcome (PerfO)

  • We help to satisfy people needs in designing clinical trials to explore new scientific evidences

    and benefit, to confirm health outcomes and to substantiate claims.

    Having in our DNA the Good Clinical Practice we interact with people to:

    Interventional platform

    discover new and safe clinical findings;

    establish a cause-effect relationship

    between product/innovation and health

    outcomes;

    facilitate market penetration with real

    and relevant clinical evidences.

    - General Toxicology Studies

    - Genetic Toxicology

    - Immunotoxicology

    - Nonclinical Pathology Services

    - Developmental and Reproductive Toxicology (DART) Studies

    - Human Phase I Studies

    - Animal Models Research

    - In Silico/In Vitro/Ex Vivo/In Vivo preliminary efficacy testing

    - Bioanalytical Services

    - Product/Drug Metabolism and Biokinetics Services

    - Bioavalability-bioequivalency assessment

    - Clinical trial

    - phase II-III Clinical Studies

    - post-Marketing Studies

  • Investigational Product Areas A global expertise focus on Fast Moving Consumer Goods

    Food/Novel Food/

    Functional ingredient

    Medical devices

    Food Supplement

    & Botanicals

    Health

    Connected devices

    Medical food

    & baby nutrition

    OTC / RX / Biotech

    Personal Care &

    Appliances

  • Investigational Health Areas Adults and Children Healthy and Diseased

    Endocrinology

    Gastroenterology

    Immunology & Allergology

    Nutrition

    Oral care

    Ophtalmology

    Cardiovascular

    Cognitive sciences

    Dermatology

    & Cosmetics

    Bone Health

    Nephrology

    Ginecology

    Urology

    Andrology

  • All rights reserved. Confidential.

    e-Technologies:

    data collection & management

  • Totally Digital People data source management

    We can digitally and virtually collect body

    outputs and enhance study innovation,

    performance, reliability and coordination.

    Health Reported Outcome

    ePRO: Patient-reported outcome

    eObsRO: Observer-reported outcome

    eClinRO: Clinician-reported outcome

    ePerfO: Performance outcome

    Computer Assisted Solution

    CAWI: Computer Assisted Web Interviewing

    CAPI: Computer Assisted Personal Interviewing

    CATI: Computer Assisted Telephone Interviewing

    e-CRF (electronic case report form)

    e-CRF & lab-data processing/automation

    Our Electronic Data Capture tool:

    Connected Devices Mobile (smartphone/tablet)

    Wearable self monitors

    A l l r i g h t s r e s e r v e d . C o n f i d e n t i a l .

  • Mediated observation

    Data Recording Specialist/Health care professional

    Outcome platform: big data flow

    Direct observation

  • Interventional platform: big data flow

    Direct observation Mediated observation

    Health care professional

  • All rights reserved. Confidential.

    Operational Structure

    and Capabilities

  • Geographic Organization Structure GLOBAL RESEARCH OPERATION HUB

    EMEAR: UNITED KINGDOM (London) /ITALY (Milan)

    ASIA/PACIFIC: SINGAPORE (Singapore)

    LATIN AMERICA: ARGENTINA (Buenos Aires)

    NORTH AMERICA: USA (Orlando)

    BIOMETRIC HUB India / UK – CBS Service company

    REMOTE MONITORING UNIT India-Hyderabad

    E-TECHNOLOGIES INNOVATION HUB India-Hyderabad

    PHASE 1 STUDY CENTER India-Hyderabad / USFDA certified

    Italy – Milan / Joint Commission certified

    LOCAL RESEARCH & CLINICAL UNIT EMEAR : United Kingdom; Ireland; Spain; Portugal; France; Switzerland; Belgium; The

    Netherlands; Italy; Germany; Austria; Czech Republic; Poland; Hungary; Croatia;

    Greece; Romania; Ukraine; Bielorussia; Russia; Finland; Sweeden; Norway; South

    Africa; Morocco; Dubai; UAE

    ASIA/PACIFIC: Singapore; Thailand; China; Japan; Indonesia; Philippines; Australia;

    New Zeland

    LATIN AMERICA: Argentina; Brazil; Mexico, Chile

    NORTH AMERICA: USA; Canada

  • Outcome platform: process

  • Outcome platform: process

  • Outcome platform: organization

    * N.B: Main key position

  • Data capture and management

    • Less administrative and cost-effective

    • Real-time data collection

    • Market shifting towards user-friendly devices

    • Increase of compliance

    • Access to study resources in a worldwide database

  • Interventional platform: process

  • Interventional platform: process

  • Intervational platform: organization

    * N.B: Main key position

  • Data capture and management

    • Enabling the complete Clinical Study Management;

    • Integrated tools facilitating real time connection;

    • Study Team Synchronization;

    • Clinical Network and Vendors Performance tracking.

    Multisite Research

    project monitoring and supervision

    Study

    Advancement Tracking

    e-CRF

    Accounts Management

  • Quality for all our researches

    Trusted Quality

    All our researches are conducted in accordance to ethical principles shaped by the Declaration of Helsinki.

    Our processes are managed and controlled by specific Standard Operating procedures, which are determined in order to improve the coordination between all

    our stakeholders involved in the research activity at a local and global level, to guarantee data protection and privacy and to enhanc

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