presentazione standard di powerpointfounders’ history they have taken risks, encouraged creativity...
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Company Presentation Edition February 2015
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We are the first digital CLO (Contract Life sciences Organization)
that provides technological solutions
& value-added services for :
Clinical Research (drug development)
Personalized Health ( genomics )
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We are a transformational life science solutions company converging
innovative digital and mobile technologies and “omics sciences”
to transcend the traditional inefficiencies and limitations of today’s
clinical research operations and patients’ healthcare.
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Founders’ History
They have taken risks, encouraged creativity and transformed
ideas into innovations to tackle big Life Sciences and Pharma challenges, starting with the way new drugs and devices are developed.
They are committed to introduce a value-based approach in clinical research and to drive change in the way physicians, patients and other sector stakeholders interact.
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Luigi Visani , MD CEO Medical Degree, University School of Medicine, Bologna, Italy. Post-garduate degree in Cardiology at the same University. Medical Director of the Italian Operative Unit at Boheringer Ingelheim Italy .Major shareholder and CEO of Hyperphar Group SpA , a leading Italian CRO . Shareholder and CEO of Pierrel spa , a CMO and CRO company, listed on the Milano stock exchange market. During his leadership the company , has been granted with both the FDA approval of its manufacturing plant in Capua (NA) for the production in sterile conditions of “small volume for parenteral injection” as well the FDA marketing authorization of a novel dental anesthetic (Orabloc) . Co-founder and CEO of Genes Holding AG, a consumer genetic company based in Lausanne (Switzerland)
Marco Romano, MD
President & COO
Medical degree at the University of Genova, Italy, where he went on to post-graduate studies in hygiene, epidemiology, and public health, followed by another post-graduate degree in clinical pharmacology at the University of Milan, Italy. He has been working for 25 years as Clinical Project Leader , Managing Director and Chief Medical Officer , in pharmaceutical and international clinical research: Parexel, ClinTrials Research,Inveresk, Charles River, Kendle and Chiltern International. He is co-author of several scientific papers on the topics of mutagenesis and cancerogenesis, pharmacokinetics and pharmacodynamics of chemical compounds and glutathione metabolism
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Augusto Zaninelli, MD, FAHA, FESO Chief Healthcare Services
Medical degree at the University of Milano, Italy, where he went on to post-graduate degree in Internal Medicine and Cardiology. General Practitioner and Associate Professor of General Practice at the School of Medicine, University of Florence. Founder and President of The Italian Stroke Organization and of The Italian Society of Medical Simulation. Affiliate to many International Scientific Societies. Promoter and coordinator of many clinical research projects. Author of more than 250 scientific papers .
Peter Minich, Master of Science Chief Technology Officer Master's program in Information Systems and Diploma’s program in Medical Documentation and Computer Science at the University of Applied Science Ulm. Freelancer in Computer Science at the Institute of Human Genetics. Research Associate at the University of Applied Science Ulm, Institute of Computer Science. Associated Director of Clinical Trials Technology Pierrel Research Europe GmbH. Director of Clinical Trials Technology at Genes SA.
Milena Crespi, CCA, Master HR Executive Director Diploma in Accounting & Business Administration in Commercial Institute in Monza , Italy. Professional experience in drug price negotiation at Pharma company. Head of General Services at Hyperphar Group, a leading Italian CRO, dealing with HR, Talents Acquisition, Procurement , Legal and IT services . Executive Director and Board Member at Pierrel Research Italy and Pierrel Research IMP.
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Corporate Office in Milano - Italy
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Value-Added Digital CRO Services
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We introduces a new vision into the inherent complexity of clinical trials by combining the expertise across medical, regulatory and operational functions with the ultimate Clinical Trial Technology solutions and “multi-omics “ sciences, to generate valuable and quality information about drug responses, drug resistance, diagnostic markers, and fundamental disease/toxicity pathways
Our unique model of embedding Technology and Science early in the planning process is proven to accelerate drug development , mitigate study risks, support data quality and to lead to significant advances in Stratified and Precision medicine
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Mission
Navigating and accelerating the value-based transformation of clinical drug development through disruptive technology and multi-omics sciences.
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Our 3C Vision
Sponsors Centric Our unique credo is to serve our Sponsors with passion, integrity, transparency, caring and innovation.
Investigators Centric We are committed to improve and facilitate the duties of investigators, through the introduction of mobile and cutting edge technological solutions.
Patients Centric We provide the assessment of molecular biomarkers to stratify patients for study drug efficacy and safety.
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Our innovative digital CRO model is based on the digital platform – Genius Suite™,
that enables integration and collaboration among functions across the spectrum of clinical trials operations :
Randomization & Supplies Handling
Sites Monitoring & Management
Data and Documents collection & Management
Project Management,
eTMF
Risk-Based Management
ePRO
PHV
Patients’ Recruitment
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Genius SUITE™ Developed in partnership with major leading technological partners , for the conduction of
Digital, Cloud, Mobile & Global Clinical Trials
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Genius SUITE™
Genius CTMS™ centralized management of all clinical trial activities
Genius LINGO™ unique mobile Voice Interactive EDC System
Genius RIBAM™ risk based adaptive management and monitoring
Genius VIGILANCE™ drug safety and Pharmaco Vigilance
Genius IMP™ drug supply , randomization , accountability and compliance
Genius PRO™ patient ‘s mobile diary and study assistant
Genius TMF™ study document collection, management and analysis
Genius ENROLL™ expedites patient recruitment and increases retention
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Value-added digital CRO
We are the first CRO that has been successfull in integrating in one single platform (Genius SUITE™) the most innovative and sophisticated digital and clouding solutions for the entire clinical trial operations
We combines the comphrensive CTT solutions of the big organizations, with the benefits of being a value-added boutique CRO, constantly focused on clients’ expectations and individual trial specificities
Exom Research, is Innovation, Passion and Excellence
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Genius CTMS™
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Genius CTMS™
Streamlines the clinical trial process by consolidating tracking and management of all clinical trial activities and information in a secure web-based system that is easily accessible across multiple sites, studies and teams
Reduces administrative costs and improve resource allocation and collaboration
Increases productivity by using a single source for maintaining critical study data and documents, reducing the need for internal staff to input data
Improves teamwork using collaboration portals that provide secure remote access
Views all subject visit data in one place across all protocols
Stays current and eliminate forgotten or overlooked tasks with staff and visit calendars
Reduces time spent looking for information and documents
Enhances the planning and effectiveness of monitoring visits
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Genius Lingo™
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Genius Lingo™
Functionalities
Unique worldwide mobile CRF that allows both the traditional manual «Touch» and the innovative dual-ways interactive «Speech» data entry
Time and resources-saving solution for filling out mCRF forms by simply speaking The spoken responses are automatically converted to text and inserted in the appropriate form fields Each Form combines recorded verbal responses with keypad choice selections Voice responses include a link to play the original audio recording, if necessary Once a form is completed, investigators are able to review, make edits and corrections if necessary,
sign and submit it to the study central application server and links to voice message files
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Genius Lingo™
Competitive Advantages
Optional voice messages transcripted in mail messages delivered to study CRAs or PMs
Increased accuracy of data collections
Improved investigators’ compliance
High quality and reliability speech-to-text and text-to-speech technologies
Compatibility with most of the smart mobile devices
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Genius RIBAM™ Risk Based Quality & Performance Management
The Traditional On-Site Monitoring approach
The on-site visits are generally conducted based on a set visit window schedule, such as every four to six
weeks and all data are source verified 100%, regardless of the type of study, safety risks, phase of the study,
stage of the study, or experience of the individuals conducting the study.
Visit objectives:
• Identify missing data in source records and data entry errors in CRFs
• Assess compliance with protocol and IMP accountability
• Evaluate Investigator supervision
• Review essential documents
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Genius RIBAM™ Risk Based Quality & Performance Management
Why Should the Traditional Monitoring approach be changed ?
The endorsement of a change in monitoring by key regulatory authorities
(FDA & EMA) serves as a rationale for looking at monitoring in a different way.
These regulatory authorities are communicating that monitoring can and
should be designed and customized to meet the specific needs of the study.
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Genius RIBAM™ Risk Based Quality & Performance Management
Industry stakeholders have recognized that although current on-site monitoring
practices do provide a level of control, advances in risk-based approaches and
technology provide an opportunity for a more holistic and proactive approach.
This philosophical shift in monitoring processes employs Centralized and Off-site
mechanisms to monitor important study parameters holistically and uses
Adaptive Onsite Monitoring to further support site processes, subject safety, and
data quality.
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Genius RIBAM™ Risk Based Quality & Performance Management
What is Risk-Based Monitoring (RIBAM) ?
An adaptive approach to clinical trial monitoring that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality.
RIBAM provides sponsors with an ability to evaluate and plan for risks before a study starts and continuously adapt monitoring activities to areas that have the most potential to impact patient safety and data quality.
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Genius RIBAM™ Risk Based Quality & Performance Management
How does RIBAM differ from “Traditional” monitoring ?
RIBAM customizes approach and/or schedule as needed based on trial related risk assessment to identify potential issues.
Leverages technology to allow the supervision of study conduct without having to be at the site location.
Shares monitoring responsibilities across many functional area
Relies more heavily on central and off-site monitoring
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Genius RIBAM™ Risk Based Quality & Performance Management
Common Principles Underlying RIBAM
Early and ongoing risk assessment
Building Quality by Design (QbD) into the study
Identifying and tracking critical processes and critical data
Use of risk indicators and thresholds
Partial source data verification
Use of centralized, off-site, and adaptive monitoring while the study is underway
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Genius RIBAM™ Risk Based Quality & Performance Management
Deploys predictive modeling techniques to assess levels of site risk, and allocate resources to areas of need
Improves the traditional site management approach
Determines the most results-oriented management strategy
Supports quantitative project risk analysis
Guarantees and documents in real time, continuous study quality
Helps sites to meet agreed-upon performace standards
Allows Sponsors to continuously follow study progress and data quality
Optimizes and adapts resources utilizations
Reduces global study costs
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Genius eTMF™
What is Genius eTMF ?
It’s our digital and validated solution for the filing of clinical trial documents
It provides a single, secure Type II certified internet data centers for all clinical
players for sharing any study document, in a standardized and fully reportable
system.
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Genius eTMF™
The benefits of eTMF
Brings all study stakeholders , CRO, Sponsors, and Investigator sites together in the regulated cloud. Sponsors get complete document visibility with real-time dashboards and actionable reports.
Tracks outstanding content and automatically places documents into the right section of the eTMF. The result is complete visibility, faster study start-up, and an inspection ready eTMF.
Supports the DIA TMF Reference Model, submission-ready rendering, auditor review support and API-based integration with Genius CTMS™.
Renders all documents in submissions-ready format (module 5 of an eCTD), already prepared for use in an HA submission. This feature eliminates significant downstream processing and removes unnecessary time and expense.
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Genius ENROLL™ Patient Recruitment & Retention
Accelerates Clinical Trials
Robust Technology Global Digital Marketing Know-How Global Clinical and Regulatory Expertise Global Reach 42 countries, 28 languages
10 Year Track Record
800+ trials in six continents Used by 8 of top 10 Pharma Companies
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Genius ENROLL™ Patient Recruitment & Retention
ClinLife® statistics 2014 36+ million visitors
Thousands of investigational sites working with ClinLife® 900,000+ registered patients in ClinLife® database
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The Omics Sciences
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The Omics Sciences
Omics based bio-markers will identify the more suitable patients for the specific investigational drug and will increase the chances for getting positive efficacy and safety data.
The integration of data-dense information from the different omics platforms at the individual levels is an essential step to develop drugs that make the personalized medicine
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The Omics Sciences
Exom Research has selected qualified Disease Specific Centres of clinical excellence
and has established partnerships with international omics experts, molecular biology
and bio-computational centres to provide the following multi-omics services :
whole genome whole exome, transcriptomics metagenomics, epigenomics proteomics validation single cell sequencing methods
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Therapeutic Areas Expertise
Oncology & Hematology
Cardiovascular & Metabolic Diseases
Central Nervous System (CNS)
Disorders
Rare Diseases
Respiratory
Infectious Diseases
Urology
Gastroenterology
Critical care
Immunology
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Services 1
Coverage of every aspect of clinical research, from First-In-Human through Proof-of-Concept up to complete Phase III- IV international clinical development programs and post-approval projects
Intelligence Support with a
complete International Regulatory Strategy & Management for Product Development Programms
Dynamic digital study
management through the integrated, complete and mobile Genius Suite®
Recruitment and assessment of clinical studies results based on patients' genetics, and other omics and bio-markers
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Services 2
Innovative solutions for
delivering rapid patient enrollment in more than 40 countries and 28 languages
Medical Imaging analysis Enhance post-marketing
surveillance and real world outcome studies with genetic data
Determine Market Access
requirements and develop strategy in the early phase
Full Pharmaco-Vigilance
pre and post marketing management services
New models for population-based research studies
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Staff & Structure
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Geographic Coverage
Our subsidiaries, field-based staff and partner CROs, provide an established infrastructure through which we are active across the whole of Europe, USA and the Asia-Pacific region.
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Organization at a Glance
Exom Research
European Organizations &
International Partnerships
International Certified CRAs
Network
Patient Recruitment
Service
Medical Imaging Analysis Center
MIAC Basel
Clinical Research
Technology
Multi - Omics Labs
Early Phase Units
International CTA Regulatory & PHV
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Competitive Advantages
Medical experts who design and monitor studies from beginning to end Strong Clinical Project Teams for superior and quality execution Global regulatory experts who can provide local knowledge support across about 90 countries Strong investigative sites and key opinion leader relationships Ultimate CTT mobile technology solutions for integrated study and data management
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Digital, Cloud & Mobile Clinical Trial Technology
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The Omics Sciences
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The Value-Added CRO Services
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We look forward to hearing from You
www.exomgroup.com