Folie 1 - Allied Clinical Management GmbH

January 7, 2018 | Author: Anonymous | Category: Science, Health Science
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Partnering with Pharmaceutical Leaders Active in Clinical Research

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Company Overview • Berlin-based CRO • Founded in 2004

• Founding member of MEDIS RESEARCH GROUP • Audited member of BVMA e.V. (in association with EUCROF) since 2009 • Specialist for study management and monitoring • Client base: international and regional biotechs, large pharma • Full-service in setting up and conducting clinical trials with our collaboration partners

www.allied-clinical.com

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Academic Sourcing • Close relationship with academic institutions training clinical research professionals

(Beuth Hochschule, Parexel Academy, Mibeg Institute) • Placements for practical training and thesis work • Early recruitment of top-of-their-class future professionals • Capacity for sudden increase of employees • High staff retention due to strong relationsships with employees

www.allied-clinical.com

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Company History • 2004 founding

Michael Roehl founds Allied Clinical Management.

• 2006 restructuring

Jörg Korb (formerly Charité) joins Allied Clinical

Management. Company restructures itself as a GmbH. • 2008 first full study

first full service study in indication ophthalmology performed.

• 2009 BVMA

ACM joins BVMA.

• 2010 first med device first full service medical device study in indication cardio-vascular disease performed. • 2013

ACM and ICRC-Weyer (Germany) collaborate as the

MEDIS RESEARCH GROUP to provide full CRO service. www.allied-clinical.com

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Company Organisation General Management

Study Management

In-House

Office Management

IT Support

Quality Management

Monitoring

Study Documentation

Regulatory Devices

Ethic Submissions

Pharmacovigilance

Data Management

Statistical Analysis

Medical Writing

Proofreading and Translation

External www.allied-clinical.com

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Quality • SOPs for all processes • Document management

• Regular, documented GCP-Training for all employees • Regular system audits by an independent auditor every 18 months • Experience with CAPA-Processes and risk-based monitoring • ACM is an audited member of the German Federal Association of Medical CROs (in association with the European CRO Federation) since 2009

www.allied-clinical.com

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Quality Management: Computer Security • Access-restricted and fire-protected facility • Back-up IT-Systems

• Mirrored servers in separate locations • Protected and access-controlled servers • Firewall + virus protection • Level-based access rights

www.allied-clinical.com

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Our Services • Study Management • Study Monitoring

• Study Documentation • Regulatory Services • Proofreading and translation →services can be contracted à la carte • Full Service as MEDIS RESEARCH GROUP

www.allied-clinical.com

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Study Management • Oversight of study conduct and study monitoring • Budget management and tracking

• Primary contact for the sponsor • Coordination of the study team • Oversight of quality and timelines • Risk assessment • Vendor management • Study set-up

www.allied-clinical.com

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Study Management • TMF set-up and maintenance • Consulting on (e)CRF selection and design

• Site feasibility and site selection • Organization / leading of investigator meetings • Creation of study documents and study specific operation guides • On-site sfety (AE / SAE / medical incidents) management • Drug supply and destruction • Clinical study report and review

www.allied-clinical.com

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Study Monitoring • Full monitoring-service, on-site and remote • Risk-based monitoring

• Site visits (selection, initiation, interim, close-out) • Source data verification • Check of study lists and documents • ISF set-up and maintenance • Training of site staff

www.allied-clinical.com

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Study Monitoring • Monitoring compliance with ICH-GCP, study protocol and regulatory requirements

• AE / SAE management • Conduct of interim analysis • Query management • Investigational product accounting • Monitoring reports and follow-up letters

www.allied-clinical.com

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Study Documentation • TMF set-up and maintenace • ISF set-up and maintenance

• Consultation on (e)CRF selection and design • Design of study documents (logs, worksheets, manuals, guidelines, • tracking lists etc.)

www.allied-clinical.com

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Regulatory Services • Clinical trial applications • Marketing applications

• Medical device applications • Collection of relevant documents • Submission package for study initiation • Submission of updated documents and changes • Completion of checklists • Correspondence with regulatory authorities and ethics committees • Regulatory advice

• Quality review www.allied-clinical.com

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Proofreading and Translation • Proofreading and translation of study protocols, patient diaries, patient information and informed consent and other key clinical texts

• Native English and German speakers

www.allied-clinical.com

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Full Service MEDIS RESEARCH GROUP offers its clients full CRO services In addition to ACM services it offers:

• Biostatistics • Data Management • Medical Writing • Pharmacovigilance • Scientific Consulting

www.allied-clinical.com

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Experience with Remote Data Capture + Management Systems • Medidata RAVE system • RDC Oracle system • Initiator eCRF system

• Science and technology on efficient information systems and study planning tools (IMPACT, Cognos clinical trial planning system etc.) and other clinical trial management systems • Cost tracking tools

www.allied-clinical.com

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Experience: Study Types 12

10

8

6

4

2

0 Phase I

Phase II

Phase III

Phase IV

www.allied-clinical.com

NIS

Medical Devices

ATMP

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Experience: Therapeutic Areas 12

10

8

6

4

2

0

www.allied-clinical.com

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Countries ACM has monitored and performed oversight visits in the following countries:

● Austria

● Israel

● Czech Republic

● Latvia

● France

● Netherlands

● Germany

● Poland

● Great Britain

● Spain

● Hungary

● Switzerland

● Italy www.allied-clinical.com

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Sponsors and Partners Sponsors ● Bayer Health Care

● GALENpharma

● Bayer Pharma AG

● Miltenyi Biotec GmbH

● BioMS Medical Corp

● Novartis

● Biotie Therapies

● Pluristem Ltd.

● Elbion AG

● Weleda AG

Partners ● ICRC-Weyer (Germany)

www.allied-clinical.com

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Contact Allied Clinical Management GmbH

MEDIS RESEARCH GROUP

Berlin office: Boyenstraße 41 10115 Berlin Tel: +49 30 - 240 47 88 0 +49 30 - 240 47 88 22 Fax:+49 30 - 240 47 88 29 22 [email protected]

[email protected] www.medis-research.com

www.allied-clinical.com

www.allied-clinical.com

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