Popsi Cube 2011

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We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the development of customized IT applications specific to the …

We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.

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  • 1. The NextGeneration CRO
    Fabrice Beauchêne
    Founder and Chairman
    6, rue Jean-Pierre Timbaud
    78180 Montigny le Bretonneux
    France
    Tél. : +33 1 80 90 50 80
    Fax : +33 1 80 90 50 89
    Email : beauchene@popsicube.fr
    www.popsicube.com
  • 2. We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the developmentof customized IT applications specific to the pharmaceutical industry
    Popsi Cube
    Offices in Europe, North America andNorth Africaas well asa vast network of Worldwide Partners
  • 3. We offer to our Pharmaceutical, Biotech and Medtech partners a complete outsourcing of their clinical trials by integrating the entirety of the value creation chain of medical product development activity
    Your Partner in Creating Value
    Our company can manage all clinical development steps, starting from the joint definition of a development strategy all the way to regulatory approval
    The success of the Popsi Cube services relies on a rigorous management of your projects through the use of a suite of proprietary tools specifically developed for clinical research
    By effectively collecting, managing and analyzing clinical data, these tools optimize the implementation of clinical trials and reduce the time-to-market for new products
  • 4. Our expertise stems from many years of experience spent inside the largest CROs or pharmaceutical companies. We always considered IT as a valuable tool and as a way to improve and industrialize processes. It is our in-depth knowledge of pharmaceutical R&D which allows us to transform these tools to support a real advance in your clinical projects
    Vision : a New Generation CRO
    The origin of Popsi Cube is a convergence between a solid clinical process and effective IT tools
    A CRO with integrated tools to address the entire clinical research functional scope
    A successful project management requires top quality human resources but also a set of tools supporting a simple, pertinent and effective decision process. Popsi Cube did not find any off-the-shelf system that would meet these objectives. We therefore have developed a set of tools specifically adapted to our services
  • 5. PHARMA, BIOTECH, MEDTECH, HEALTHCARE, LIFE SCIENCES
    Our Expertise
    Portfolio Clinical Research & IT Tools Designed, Developed & Managed Internally
    Large worldwide partner network
    Recognized experts
    Turn key projects
    Resourcefulness
    Analysis of medical needs
    Protocol definition
    Design and analysis plan
    Assessment of product safety and risk / benefit ratio
    Regulatory and administrative support
    Clinical Research
    100% web based
    Use of a flexible and easy to integrate professional framework
    Computer system validation
    Development and management of specific applications and websites
    Websites: Optimization of site referencing, Google analytics, dashboards
    Hosting in secure environment
    Several platforms: web, smartphone, tablets
    Custom SoftwareDevelopment
    Our Tools
    Simple, fast and reliable data capture solution by digital pen
    Digital pen for electronic data capture
    Handwriting recognition software and direct integration of digital data
    Fast and reliable data capture using a web solution
    On-line solution for clinical data capture with possible on course customization
    Simple and secure solution for patient allocation to treatment groups
    IVRS & IWRS: Interactive voice and internet based solution to randomize patients
    Easy set-up of link with other tools (Drug Management systems, CTMS …)
    eTrial web platform fully customizable
    Web portal forstudies with secure and personalized access
    Several modules: eCRF, dashboards, documents, eLearning, quiz, news, video
    Software Editor
    Patent-protected 100% web solution
    Global vision of your development program (past, present, future)
    Management tool for your portfolio of projects using parametric planning
    Demand management and analysis of headcount requirements
    Tool to support decision making process for optimal resource utilization
    Reduced time for information sharing
    Centralization of data
    Electronic Document Systems
    Management tool for post-marketing medical information and documents
    Information web portal and audit trail of questions and answers
    Management of standard letters and utilization of addresses in your customer database
    Simple: Uses only a dozen variables collected on the various investigator sites and produces required dynamic dashboards
    Management tool for clinical trial monitoring, Key indicators of monitoring visits, dashboard creation tool and projected oversight
  • 6. CLINICAL RESEARCH & INFORMATION TECHNOLOGY
    Preclinical
    Phase I
    Phase II & III
    Late Phase
    Patient Follow Up
    Popsiplan: Portfolio Project Plan & Workforce Management
    Popsimed: Medical Health Information Management
    Popsitoring: Dashboard – Activity Monitoring
    APPLICATIONS
    Popsipen: Digital Pen & Paper
    PopsiCRF: eCRF & ePRO
    Popsirando: IVRS & IWRS (Vocal – Web)
    Hospital Database
    Methodology – Analysis Plan Statistics – Feasibility
    SERVICES
    Set-up – Initiation – Monitoring –Close Out – Data Management
    Report – FDA /EMA Registration Support – Scientific Publication
    Skills ConvergenceExperts In Both Clinical Research & IT
  • 7. CLINICAL RESEARCH & INFORMATION TECHNOLOGY
    Preclinical
    Phase I
    Phase II & III
    Late Phase
    Patient Follow Up
    Popsiplan: Portfolio Project Plan & Workforce Management
    Popsimed: Medical Health Information Management
    We follow the cycle lifeof your product
    Our job is to provideyou the best quality data in minimum time
    Popsitoring: Dashboard – Activity Monitoring
    APPLICATIONS
    Popsipen: Digital Pen & Paper
    We cannot imagine managing clinical research without any competence in databaseor information technology
    PopsiCRF: eCRF & ePRO
    Popsirando: IVRS & IWRS (Vocal – Web)
    Hospital Database
    Methodology – Analysis Plan Statistics – Feasibility
    SERVICES
    Set-up – Initiation – Monitoring –Close Out – Data Management
    Report – FDA /EMA Registration Support – Scientific Publication
    Skills ConvergenceExperts In Both Clinical Research & IT
  • 8. Turnkey Project Offer
    Project & Data ManagementStudy Set-up
    Definition of Implementation Strategy
    Definition of Development Strategy
    Final Assessment Study Report
    Statistical Analysis
    Clinical Report
    Publication
    Site initiation
    Study Monitoring
    Supply Tracking
    Query Management
    Site Close-up
    Protocol Development
    Informed Consent Form Development
    Feasibility Assessment
    Selection of Study Sites
    Need Analysis
    Methodology
    Strategic Advice
    Regulatory and Administrative Support
    Your study ManagedandInstrumented fromStart to Finish
    Project Follow-up Through Development of IT Dedicated or Custom Applications
  • 9. Field Proven Therapeutic Experience
  • 10. Strong Expertise & References
    BIOTECH
    PHARMA
    ADB Pharma
    Biocortech
    Diamyd
    ERYtechPharma
    Genzyme
    Ophtimalia
    Roche USA
    MSD
    Daiichi Sankyo
    LEO Pharma
    IPSEN
    Boehringer Ingelheim
    Mundi Pharma
    LFB
    DNDi
    MEDTECH
    HOSPITAL
    Cochlear
    Med-el
    Advanced Bionics
    Neurelec
    Winncare - Asklé
    BodyCap
    InstitutMutualisteMontsouris
    Armand-Trousseau (APHP)
    Cochin (APHP)
  • 11. Case Study
    The French National Health Authority requests the 4 manufacturers of cochlear implants to provide efficacy, safety and quality of life clinical data for all patients implanted starting in 2011 for the next 3 years in order to support reimbursement decision by the French National Insurance Funds
    Business Drivers
    Major Achievements
    Client Benefits
    Popsi Cube Products
    Competitive environment
    Provide different view of data to Physicians, Manufacturers, Health Authority
    Management of 4 competitors on same project
    Management of independent scientific board
    Trusted third party
    Global agreement
    Very competitive costs
    Very simple and easy to use eCRF
    First patient recruited 2 months before the estimated Health Authority date
    Almost all new implanted patients recruited
    Study implementation and regulatory dossier was performed simultaneously with the eCRF development and the contract negotiation
    Study costs shared
    Popsi Cube works as trusted third party and represents the manufacturers to Health Authorities
    July 2011 Medicare USA requires similar study !
    Trial web platform including eCRF with the ability to adapt the forms during the studies and allow different vision of the data and main statistics
  • 12. Commitment
    Thoroughnessat your service
    Unflinching demandfor Quality
    Availabilityof ouremployees
    Reactivityto your needs
    Customer Oriented Values
    Reduce costsand boost Productivity
    Commitmenton resourcesand results
  • 13. Contact Us
    Fabrice Beauchêne
    Founder and Chairman
    6, rue Jean-Pierre Timbaud
    78180 Montigny le Bretonneux
    France
    Tél. : +33 1 80 90 50 80
    Fax : +33 1 80 90 50 89
    Email : beauchene@popsicube.fr
    Are you ready to outsource any new project ?
    Think
    Contact us today to get started !
    Images Credits: © fotolia ©Cochlear™ ©Popsi Cube