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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 valuableand 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 andimplement protocols for outcome & clinical research, to collect insights, to understand healthdynamics, to build science and to support claims.

Our mission

Emmanuel PauzeManaging 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 AreasA 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 AreasAdults and Children Healthy and Diseased

Endocrinology

Gastroenterology

Immunology & Allergology

Nutrition

Oral care

Ophtalmology

Cardiovascular

Cognitive sciences

Dermatology

& Cosmetics

Bone Health

Nephrology

Ginecology

Urology

Andrology

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e-Technologies:

data collection & management

Totally DigitalPeople 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 DevicesMobile (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

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Operational Structure

and Capabilities

Geographic Organization StructureGLOBAL RESEARCH OPERATION HUB

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

ASIA/PACIFIC: SINGAPORE (Singapore)

LATIN AMERICA: ARGENTINA (Buenos Aires)

NORTH AMERICA: USA (Orlando)

BIOMETRIC HUBIndia / UK – CBS Service company

REMOTE MONITORING UNITIndia-Hyderabad

E-TECHNOLOGIES INNOVATION HUBIndia-Hyderabad

PHASE 1 STUDY CENTERIndia-Hyderabad / USFDA certified

Italy – Milan / Joint Commission certified

LOCAL RESEARCH & CLINICAL UNITEMEAR : 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 enhance constantly our Quality.

We are certified ISO9001:2008.

But not only…For our clinical research services we strictly follow the principles of the International Conference on Harmonization

(ICH) and guidelines for Good Clinical Practice (GCP) and we act in accordance to the applicable local regulatory

requirements.

We are committed to protect as much as possible the animal welfare and we apply the 3Rs principles

(Replacement, Reduction and Refinement) to contribute limiting the number of animals used.

We work with Hospitals, Laboratories and Research Partners that have Standards in place for quality compliance

in conducting clinical trials, laboratory analysis (GLP), monitoring, reporting, storing as required by any local

standards and certified by local authorities .

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Contact Information:

Cesare Mutti

Research & Clinical Services Business Development

cesare.mutti@sprim.com

Tel. +39-0245495838

Mob. +39-3939038970

www.sprim-als.com

Scientific publications available upon request