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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 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
Tel. +39-0245495838
Mob. +39-3939038970
www.sprim-als.com
Scientific publications available upon request