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
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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 Jrg Korb (formerly Charit) joins Allied
Clinical

Management. Company

restructures itself as a GmbH.

2008 first full study first full service study in indication
ophthalmology
2009 BVMA

performed.
ACM joins BVMA.

2010 first med device

first full service medical device

study in indication

cardio-vascular
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Company Organisation
General
Manageme
nt

Study
Manageme
nt

InHouse

Office
Manageme
nt

IT Support

Quality
Manageme
nt

Monitoring

Study
Documentation

Regulatory
Devices

Ethic
Submission
s

Pharmacovigilance

Data
Manageme
nt

Statistical
Analysis

Medical
Writing

External
www.allied-clinical.com

Proofreadin
g and
Translation

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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 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

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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 + Manageme

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

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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
Great Britain
Hungary

Poland
Spain
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
GROUP
Berlin office:
Boyenstrae 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
www.allied-clinical.com

www.allied-clinical.com

MEDIS RE

info@medis-research.com
www.medis-resear