The NextGeneration CRO<br />Fabrice Beauchêne<br />Founder and Chairman<br />6, rue Jean-Pierre Timbaud <br />78180 Montig...
We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research impl...
We offer to our Pharmaceutical, Biotech and Medtech partners a complete outsourcing of their clinical trials by integratin...
Our expertise stems from many years of experience spent inside the largest CROs or pharmaceutical companies. We always con...
PHARMA, BIOTECH, MEDTECH, HEALTHCARE, LIFE SCIENCES<br />Our Expertise<br />Portfolio Clinical Research & IT Tools Designe...
CLINICAL RESEARCH & INFORMATION TECHNOLOGY<br />Preclinical<br />Phase I<br />Phase II & III<br />Late Phase<br />Patient ...
CLINICAL RESEARCH & INFORMATION TECHNOLOGY<br />Preclinical<br />Phase I<br />Phase II & III<br />Late Phase<br />Patient ...
Turnkey Project Offer<br />Project & Data ManagementStudy Set-up<br />Definition of Implementation Strategy<br />Definitio...
Field Proven Therapeutic Experience<br />
Strong Expertise & References<br />BIOTECH<br />PHARMA<br />ADB Pharma<br />Biocortech<br />Diamyd<br />ERYtechPharma<br /...
Case Study<br />The French National Health Authority requests the 4 manufacturers of cochlear implants to provide efficacy...
Commitment<br />Thoroughnessat your service<br />Unflinching demandfor Quality<br />Availabilityof ouremployees<br />React...
Contact Us <br />Fabrice Beauchêne<br />Founder and Chairman<br />6, rue Jean-Pierre Timbaud <br />78180 Montigny le Breto...
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Popsi Cube 2011

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.
Published on: Mar 4, 2016
Published in: Health & Medicine      Business      
Source: www.slideshare.net


Transcripts - Popsi Cube 2011

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

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