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
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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
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
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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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