The Advanced Therapies CROThe smart choice for biotechs and
medtechs
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The large majority of the developments fail more or less prematurely (attrition rate in clinical studies: 90%)
86% of studies fail to enroll subjects in the contracted time
1 out of 4 patients drops out of a study after enrollment
15 to 40% of opened centres remain inactive
Authorities’ requirements are more and more demanding: Clinical development, Risk Management Plan,…
European administrative complexity and herogeneity are a source of important red tape and headaches
…
Reduce Time to Market and Control the Costs, But…
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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Fate?
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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As a long-established high-quality European CRO, Advanced Drug Development Services (ADDS) Group contributes to successfully bring as early, safely and cost effectively as possible your products to the market in a unique one-stop shop approach for Europe.
ADDS helps you to:Conceive your complete development program and risk management planSecure your administrative submissionsSelect the right investigator sitesShorten the recruitment timeImprove the patient retention ratioAnticipate the risks and solve the issuesMeet the Regulatory requirements
ADDS offers European Qualified Person Representation for Pharmacovigilance
ADDS mission
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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High level of repeat business
Transparency and Anticipation• Drafting of a Communication Management Plan for each project• Key Performance Indicators (KPI) defined in accordance with the
sponsor• Study Web Portal• Audits: SOPs, Systems,…• Risk anticipation based on the « real-life » knowledge
Respect of the commitments• Timeline• Services• Budget
Quality Improvement• Periodical Learned Lessons Meetings with the sponsor• Corrective actions
Stable and dedicated project teams
Our customers are our most valuable asset
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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A network of companies in drug & medical device development creating a virtual European company with an unequalled level of expertise and skills at each stepOne unique entry point to streamline all your development pathFounding members:
The Advanced Therapies CROThe smart choice for biotechs and medtechs
Convergence, the unique «one-stop shop » initiative to access the European market
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Convergence, the unique «one-stop shop » initiative to accompany all your medicinal product life
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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R&D Biocompatibility Testing
Clinical Phases CE Marking Pilot Pivotal
Regulatory strategy
Critical Data review→ Risk Analysis
IB/CTA
Investigational Plan
Instructions for Use
Quality Management System (scale-up)
Meeting NB
Regulatory strategy
Compilation of Investigational Studies Applications (IB/CTA)
Critical Data review→ Risk Management Plan
Quality Management System
Instructions for Use, Labels
Design / technical file
Meeting NB
Regulatory Strategy
Critical Data review→ Risk Analysis
Biocompatibility Studies PlanAccording to ISO 10993
Prototypes
Manufacturing SOPs
Regulatory strategy
Design/Technical File
Instructions For Use /Labels (translations)
Audit NB
Notification First Placing on the Market
Convergence, the unique «one-stop shop » initiative to accompany all your medical device life
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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Development Strategy ConsultingOne team, One Project ManagerComplete and audited SOPs and systemsSpecial attention and methods for trial critical phases• Feasibility Studies
• Centre Preselection
• Submission management
• Centre implementation
• FPI / centre
• Safety
• Query management: monitoring guide, data management documentation, last queries
• Data Base Lock
Innovative design and solutions• Adaptive studies
• eCRF, Web Portal
• ePRO (Digital Pen, ...)
The operational excellence to speed up your trials at the best quality/price ratio
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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Privileged access to investigators and patients in emerging countries• Central Eastern Europe
• Maghreb, Egypt
Site Support : Improvement of the ratio of active centres• The investigators too are considered as customers
• Special attention to investigators’ training
• Quality of human relationships between CRAs and Doctors
• Possible availability of study nurses to support the investigators
Patient Supply Chain• Lisibility tests of Patient Informed Consents
• Patient Support and Accompaniment: Web, Call Center, Home
Patient recruitment and Patient retention Accelerator
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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Services in Vigilances & Risk Management
Risk Management Pharmacovigilance
Medical Device Vigilance
Biovigilance Blood Safety
OUTSOURCING
STRATEGIC COUNSELING
Approval dossierSafety Part
Counseling Counseling
QA/QC SOPs - Audit
Training Data base
Regulatory Survey
EUQPPV
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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ADDS Profile
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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Counseling in Clinical DevelopmentCounseling in Clinical DevelopmentCounseling in Clinical DevelopmentCounseling in Clinical Development
Medical writingMedical writingMedical writingMedical writing
Clinical Research operationsClinical Research operationsClinical Research operationsClinical Research operations
Data Management & BiostatisticsData Management & BiostatisticsData Management & BiostatisticsData Management & Biostatistics
Post Marketing StudiesPost Marketing StudiesPost Marketing StudiesPost Marketing Studies
Safety and Risk ManagementSafety and Risk ManagementSafety and Risk ManagementSafety and Risk Management
InSourcingInSourcingInSourcingInSourcing
Regulatory AffairsRegulatory AffairsRegulatory AffairsRegulatory Affairs
Services
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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Quality Management SystemQuality Assurance Officer
Internal and external audits (customer, independent)
Customer Satisfaction Metrics
43%
57%
0% 0%
0%
10%
20%
30%
40%
50%
60%
Very High High Bad Very Bad
Very High High Bad Very Bad
Quality Management System
The Advanced Therapies CROThe smart choice for biotechs and medtechs
Geographical coverage
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• AllergyAllergy• AnesthesiaAnesthesia• Asthma and BPCOAsthma and BPCO• CardiologyCardiology• CNSCNS• DermatologyDermatology• DiabetesDiabetes• Drug/Device Combination ProductsDrug/Device Combination Products• Endocrinology Endocrinology • GynecologyGynecology• HematologyHematology• Infectious diseasesInfectious diseases• Medical devicesMedical devices• OncologyOncology• PediatryPediatry• PsychiatryPsychiatry• RheumatologyRheumatology• SurgerySurgery• UrologyUrology
• AllergyAllergy• AnesthesiaAnesthesia• Asthma and BPCOAsthma and BPCO• CardiologyCardiology• CNSCNS• DermatologyDermatology• DiabetesDiabetes• Drug/Device Combination ProductsDrug/Device Combination Products• Endocrinology Endocrinology • GynecologyGynecology• HematologyHematology• Infectious diseasesInfectious diseases• Medical devicesMedical devices• OncologyOncology• PediatryPediatry• PsychiatryPsychiatry• RheumatologyRheumatology• SurgerySurgery• UrologyUrology
Fields of expertise
The Advanced Therapies CROThe smart choice for biotechs and medtechs
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For any information, feel free to contact:
Patrice Le Guen
Senior Global Business Manager
Advanced Drug Development Services SAS
56, Quai Alphonse le Gallo
92513 Boulogne-Billancourt Cedex – France
Tel: +33 1 46 99 63 05
Mobile : +33 6 71 44 01 90
E-mail : [email protected]
Web site : www.adds.com
The Advanced Therapies CROThe smart choice for biotechs and medtechs