clinical trial supply services

Transcription

clinical trial supply services
CLINICAL TRIAL
SUPPLY SERVICES
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Commercial Product Sourcing & Blinding
Packaging & Labelling
QP & Analytical Support Services
Global Distribution & Depot Network
Supply Chain Management
IXRS® (IVR/IWR) Technology
GLOBAL CLINICAL TRIAL SOLUTIONS FOR
YOUR PROTOCOL NEEDS
Almac has over 25 years’
experience delivering a
full range of innovative
clinical trial supply and
technology solutions
to pharmaceutical and
biotech companies
worldwide. We are the
most trusted and stable
name in the clinical
supply marketplace.
North America
USA
Souderton, PA (HQ)*
Durham, NC (Almac Facility)
Canada
Mexico
Headquartered in Craigavon,
Northern Ireland - with US
operations based in Durham,
North Carolina and Souderton,
Pennsylvania, as well as our newly
opened facility in Singapore Almac champions integrated
clinical supply and technological
excellence to make your clinical
trials more effective and efficient.
We pride ourselves on
working with all types of
company, from virtual and
biotech, to multi-national
pharmaceutical companies.
Europe
UK (HQ)*
Austria
Belarus
Belgium
Bulgaria
Croatia
Czech Rep.
Denmark
Finland
France
Germany
Hungary
Israel
Italy
Netherlands
Norway
Poland
Romania
Above all, we are differentiated by
our exceptional client service powered by an experienced team
of knowledge-based project
management specialists.
Continual investment in our staff,
global facilities and the ongoing
delivery of innovative services
position us as the premium
provider of clinical trial supply
chain solutions worldwide.
Russia
Slovakia
Spain
Sweden
Turkey
Ukraine
Our new facility in
Singapore, as well as
our support office in
Japan, allow Almac to
offer a full clinical trial
service to our Asia
Pacific customers,
supported by a regional
team of Almac experts.
Asia
China
Hong Kong
India
Japan
Philippines
Singapore
South Korea
Taiwan
Thailand
Central
America
Guatemala
Panama
South
America
Argentina
Brazil
Chile
Colombia
Peru
● Global Headquarters*
Africa
South Africa
● Depot
Australia
● Regional depot with ability to ship to countries outside of the depot country
NOT JUST EXPERIENCE. FORESIGHT.
WE TURN EXPERIENCE INTO FORESIGHT AND ANTICIPATE THE NEEDS,
CHALLENGES, AND OPPORTUNITIES IN THE EVOLVING AND EVER-CHANGING
INDUSTRY OF GLOBAL CLINICAL TRIALS.
COMPARATOR SOURCING & BLINDING
• Global sourcing of comparator products for
clinical trials.
• Over-encapsulation services - from single tablet
to complex fills.
• Many novel approaches to product blinding
including inhaler device blinding.
• Clinical trial manufacture – via Almac
Pharma Services.
PACKAGING & LABELLING
• Huge global capacity and effective use
of automation.
• Range of blistering, bottling and carding/
walleting lines to suit study demands.
• Flexibility to cope with small scale requirements
through to mega-trials.
IMPs for use in clinical studies. Our QPs are widely
known and respected within the industry, providing
invaluable consultancy services to our client base.
GLOBAL DISTRIBUTION & DEPOT NETWORK
• Experience in shipping thousands of kits to
existing and new trial destinations.
• Global capacity and growing depot network.
• Specialists in cold-chain, controlled drug and
controlled ambient shipping.
• STEMS (Shipping Temperature Electronic
Monitoring System) - automatic upload of USB
temperature monitors on-site.
• Range of qualified shipper and monitor solutions.
• Direct to Patient services available in the US,
Canada and EU (subject to criteria).
• Returns, accountability and destruction services.
• High output blistering and in-line walleting to
cope with large program volumes.
• Pack design and format advice for optimum
processing and study fit.
• Label printing, on-line label approval and
automated label verification.
ANALYTICAL SERVICES
Delivering comprehensive analytical solutions to
support your drug substance (API) and drug product
development programmes. We can also provide
analytical and microbiological testing solutions for
clinical / commercial drug product supply.
EU QUALIFIED PERSON SERVICES (QP)
We have a comprehensive team of experienced QPs
who are able to assist clients with the importation
of materials into the EU - as well as the release of
SUPPLY CHAIN MANAGEMENT
Almac’s Supply Chain Management experts offer
years of experience, flexibility to fit our clients’ needs
and a dedicated focus on the patient.
• Dedicated Supply Chain Management
Team to plan, build and manage your
clinical supply chain.
• Integrated technology for the forecasting,
planning and global oversight of clinical inventory.
• IXRS® (IVR/IWR) solutions to manage
randomisation and supply.
• WebEZTM - a configurable web-based
randomisation system, ideal for smaller trials.
• Temperature Surveillance – end-to-end
monitoring to eliminate excursions and manage
risk across the entire supply chain.
• Pharmacy Services.
www.almacgroup.com
ALMAC GROUP ACROSS THE GLOBE
Global Headquarters, UK
Durham, USA
US Headquarters
Asia Pacific Headquarters
All our clients have unique needs.
That’s why we develop unique solutions.
This is the
GET IN TOUCH
UK
Almac Group
(Global Headquarters)
9 Charlestown Road
Seagoe Industrial Estate
Craigavon
BT63 5PW
United Kingdom
US
Almac Group
(US Headquarters)
25 Fretz Road
Souderton, PA 18964
United States of America
ASIA PACIFIC
Almac Pharmaceutical
Services Pte. Ltd.
(Asia Pacific Headquarters)
9 Changi South Street 3
#01-01
Singapore 486361
[email protected]
+44 28 3836 2436
[email protected]
+1 215 660 8500
[email protected]
+65 6309 0720
AM5103