1. Partnering with Pharmaceutical Leaders Active in Clinical Research

2. Company Overview Berlin-based CRO Founded in 2004
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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

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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

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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.
ACM and ICRC-Weyer (Germany) collaborate as the MEDIS RESEARCH GROUP to provide full CRO service.

5. Proofreading and Translation
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Company Organisation
General Management
Office Management
IT Support
Quality Management
Monitoring
Study Documen-tation
Regulatory Devices
Ethic Submissions
Pharmaco-vigilance
Data Management
Medical Writing
Statistical Analysis
Proofreading and Translation
Study Management
In-House
External

6. Quality SOPs for all processes Document management
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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

7. Quality Management: Computer Security
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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

8. Our Services Study Management Study Monitoring Study Documentation
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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

9. Study Management Oversight of study conduct and study monitoring
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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

10. Study Management TMF set-up and maintenance
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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

11. Study Monitoring Full monitoring-service, on-site and remote
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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

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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

13. Study Documentation TMF set-up and maintenace
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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.)

14. Regulatory Services Clinical trial applications Marketing applications
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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

15. Proofreading and Translation
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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

16. Full Service MEDIS RESEARCH GROUP offers its clients full CRO services
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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

17. Experience with Remote Data Capture + Management Systems
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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

18. Experience: Study Types
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Experience: Study Types

19. Experience: Therapeutic Areas
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Experience: Therapeutic Areas

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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

21. Sponsors and Partners Sponsors ● Bayer Health Care ● GALENpharma
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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)

22. Contact Allied Clinical Management GmbH MEDIS RESEARCH GROUP
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Contact
Allied Clinical Management GmbH MEDIS RESEARCH GROUP
Berlin office:
Boyenstraße Berlin Tel:
Fax: