Partnering with Pharmaceutical Leaders Active in Clinical Research
Company Overview
DO IT RIGHT THE FIRST TIME!
• 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 2
Academic Sourcing
DO IT RIGHT THE FIRST TIME!
• 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 3
Company History
DO IT RIGHT THE FIRST TIME!
www.allied-clinical.com 4
• 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.
Company Organisation
DO IT RIGHT THE FIRST TIME!
www.allied-clinical.com 5
General Management
Office Management IT Support Quality
Management
MonitoringStudy
Documen-tation
Regulatory Devices
Ethic Submissions
Pharmaco-vigilance
Data Management
Medical Writing
Statistical Analysis
Proofreading and
Translation
Study Management
In-House External
Quality
DO IT RIGHT THE FIRST TIME!
• 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 6
Quality Management: Computer Security
DO IT RIGHT THE FIRST TIME!
• 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 7
Our Services
DO IT RIGHT THE FIRST TIME!
• 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 8
Study Management
DO IT RIGHT THE FIRST TIME!
• 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 9
Study Management
DO IT RIGHT THE FIRST TIME!
• 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 10
Study Monitoring
DO IT RIGHT THE FIRST TIME!
• 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 11
Study Monitoring
DO IT RIGHT THE FIRST TIME!
• 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 12
Study Documentation
DO IT RIGHT THE FIRST TIME!
• 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 13
Regulatory Services
DO IT RIGHT THE FIRST TIME!
• 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 reviewwww.allied-clinical.com 14
Proofreading and Translation
DO IT RIGHT THE FIRST TIME!
• 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 15
Full Service
DO IT RIGHT THE FIRST TIME!
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 16
Experience with Remote Data Capture + Management Systems
DO IT RIGHT THE FIRST TIME!
• 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 17
Experience: Study Types
DO IT RIGHT THE FIRST TIME!
www.allied-clinical.com 18
Experience: Therapeutic Areas
DO IT RIGHT THE FIRST TIME!
www.allied-clinical.com 19
Countries
DO IT RIGHT THE FIRST TIME!
www.allied-clinical.com 20
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
Sponsors and Partners
DO IT RIGHT THE FIRST TIME!
www.allied-clinical.com 21
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)
Contact
DO IT RIGHT THE FIRST TIME!
www.allied-clinical.com 22
Allied Clinical Management GmbH MEDIS RESEARCH GROUP
Berlin office: [email protected]ße 41 www.medis-research.com 10115 BerlinTel: +49 30 - 240 47 88 0 +49 30 - 240 47 88 22Fax:+49 30 - 240 47 88 29 [email protected]
www.allied-clinical.com