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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 pharmaceutical industry.
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The Next Generation CROFabrice 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 : [email protected]
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
Popsi Cube
Offices in Europe, North America and North Africa as well as a vast
network of Worldwide Partners
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
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 scopeA 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
PHARMA, BIOTECH, MEDTECH, HEALTHCARE, LIFE SCIENCESOur Expertise
Our Tools
Software Editor
Portfolio Clinical Research & IT Tools Designed, Developed & Managed Internally
Custom SoftwareDevelopment
Clinical Research
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
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
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
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 for studies with secure and personalized access Several modules: eCRF, dashboards, documents, eLearning, quiz, news, video
Preclinical Phase I Phase II & III Late Phase Patient Follow Up
CLINICAL RESEARCH & INFORMATION TECHNOLOGY
AP
PLI
CA
TIO
NS
SE
RV
ICE
S
Popsiplan: Portfolio Project Plan & Workforce Management
Popsimed: Medical Health Information Management
Popsitoring: Dashboard – Activity Monitoring
Popsipen: Digital Pen & Paper
PopsiCRF: eCRF & ePRO
Popsirando: IVRS & IWRS (Vocal – Web)
Methodology – Analysis Plan Statistics – Feasibility
Set-up – Initiation – Monitoring – Close Out – Data Management
Report – FDA /EMA Registration Support – Scientific Publication
Hospital Database
Skills ConvergenceExperts In Both Clinical Research & IT
Preclinical Phase I Phase II & III Late Phase Patient Follow Up
CLINICAL RESEARCH & INFORMATION TECHNOLOGY
AP
PLI
CA
TIO
NS
SE
RV
ICE
S
Popsiplan: Portfolio Project Plan & Workforce Management
Popsimed: Medical Health Information Management
Popsitoring: Dashboard – Activity Monitoring
Popsipen: Digital Pen & Paper
PopsiCRF: eCRF & ePRO
Popsirando: IVRS & IWRS (Vocal – Web)
Methodology – Analysis Plan Statistics – Feasibility
Set-up – Initiation – Monitoring – Close Out – Data Management
Report – FDA /EMA Registration Support – Scientific Publication
Hospital Database
Skills ConvergenceExperts In Both Clinical Research & IT
We follow the cycle lifeof your product
We cannot imagine managing clinical research without any competence in database
or information technology
Our job is to provideyou the best quality data
in minimum time
Final Assessment Study Report
Statistical Analysis Clinical Report Publication
Turnkey Project Offer
Regulatory and Administrative Support
Project Follow-up Through Development of IT Dedicated or Custom Applications
Project & Data ManagementStudy Set-up
Site initiation Study Monitoring Supply Tracking Query Management Site Close-up
Definition of Implementation
Strategy
Protocol Development Informed Consent Form
Development Feasibility Assessment Selection of Study Sites
Definition of Development Strategy
Need Analysis Methodology Strategic Advice
Your study Managed and Instrumented
from Start to Finish
Tools Study Phase and Type
Central Nervous System
Paper CRFeCRF
Pilot Phase: BiomarkersPhase II: Traumatic brain injury, spinal cord surgeryPhase III: Depression, schizophrenia, epilepsy, Parkinson
PneumologyeCRFeCRF
Paper CRF
Phase II: Chronic Obstructive Pulmonary DiseasePhase III: Pulmonary embolismPhase III: Pulmonary thrombosis
OncologyPhase II: Pancreatic cancer Hospital Database: Patients follow-up in urology departmentHospital Database: Toxicology follow-up of cancer protocol treatment
Cardiology Paper CRF Phase IV: Cardiology – Nutrition – Sport
Virology eCRF PMS: 5 years flu mutation surveillance study
DermatologyPaper CRF Phase II: Cosmetology
Patient Registry with online image analysis for scoring
Endocrinology Phase III: Type II – Pancreatic protection
Ophtalmology Paper CRF Phase III et IV: Glaucoma
Hematology Paper CRF Phase I/II: Myelodysplastic syndrome
Rheumatology Paper CRF Phase IV: Pain management
Medical DevicesPatient Registry: Cochlear implant quality of life - 4 clients collaborative industry studyPrice Review: Mattress with pressure air system for prevention or treatment aid for bedsoresHospital Database: Patients follow-up in otology department
Field Proven Therapeutic Experience
Strong Expertise & References
ADB PharmaBiocortech
DiamydERYtech Pharma
GenzymeOphtimalia
BIOTECH
CochlearMed-el
Advanced BionicsNeurelec
Winncare - AskléBodyCap
MEDTECH
Roche USAMSD
Daiichi SankyoLEO Pharma
IPSENBoehringer Ingelheim
Mundi PharmaLFBDNDi
PHARMA
Institut Mutualiste MontsourisArmand-Trousseau (APHP)
Cochin (APHP)
HOSPITAL
Case StudyThe 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
July 2011 Medicare USA requires similar study !
Business Drivers
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
Major Achievements
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
Client Benefits
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
Popsi Cube Products
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
Commitment
Thoroughnessat your service
Unflinching demand
for Quality
Availabilityof our
employees
Reactivityto your needs
Reduce costsand boost
Productivity
Commitmenton resourcesand results
Customer Oriented Values
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 : [email protected]
Are you ready to outsource any new project ?Think
Contact us today to get started !
Images Credits: © fotolia ©Cochlear™ ©Popsi Cube
