the advanced therapies cro the smart choice for biotechs and medtechs

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?


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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


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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


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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:


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


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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


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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


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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


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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


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ADDS Profile


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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


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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


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


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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 cro the smart choice for biotechs and medtechs

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