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
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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.
• 2013
ACM and ICRC-Weyer (Germany) collaborate as the
MEDIS RESEARCH GROUP to provide full CRO service.
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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
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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
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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
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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
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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
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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
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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
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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.)
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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
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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
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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
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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
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Experience: Study Types
12
10
8
6
4
2
0
Phase I
Phase II
Phase III
Phase IV
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NIS
Medical
Devices
ATMP
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Experience: Therapeutic Areas
12
10
8
6
4
2
0
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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
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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)
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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
info@allied-clinical.com
info@medis-research.com
www.medis-research.com
www.allied-clinical.com
www.allied-clinical.com
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