Industry Provider Profiles Company Type Services
Almac Clinical Services provides a global service for the
manufacture, packaging, labeling, distribution, return and
analysis of clinical trial supplies. Our cGMP facilities located in
North America (Souderton, PA and Durham, NC) and Europe
(Craigavon, UK) combine experience and flexibility to rapidly
respond to your clinical requirements. Almac Clinical Services has
evolved from a contract trial packaging supply organisation to a
full service clinical supplies management company. Our automated
equipment and advanced technology are designed to provide our
customers with full access to information, while maintaining a
flexible, efficient and quality service. Our global depot network
provides clients with unrivalled coverage for their clinical
trials
Almac Clinical Services also provides full analytical services
including release by a Qualified Person of supplies on first entry
into Europe and stability testing of products including the
necessary method development and validation.
IVRS systems for the management of clinical studies are provided
by our Clinical Technologies division; web address: http://www.almacgroup.com/clinical-technologies/ .
Blinding of tablets by over encapsulation
Blinding of Inhaler devices
Manufacture of placebo capsules
Sourcing and purchasing of comparator products
Blister packaging
Thermoform
Polypropylene
Coldform (Alu/Alu)
Tooling designed and produced in-house
Calendar pack blisters
Child resistant/Senior friendly wallet cards
Automated bottle filling
Controlled humidity suites
Containment suites
Almac Clinical Services have specialised dedicated facilities
for the packaging of penicillins and cephalosporins, it is also
licensed to package controlled scheduled II to IV drug products.
Almac Clinical Services provides a unique service for the blinding
of comparator inhaled products and also for the preparation of
placebo blinded comparator inhaled products.
Design and printing of labels
Open and blinded labels
Printing of all foreign languages
Randomized booklet labels
Bar coded labels
Automated labeling and compilation of supplies
Manual kit labeling and assembly
Automated Label Verification
Global Depot Network including LA, SE Asia, India &
China
Controlled temperature storage
Ambient
Refrigerated 2 - 8° centigrade
Frozen -20° to -80° centigrade
Cryogenic -170° C
Customer access to global inventory via internet
IVR controlled distribution
Just in time shipments to sites
Cold Chain expertise, shipper design and validation
Dedicated return units in US and EU
Destruction services
Raw material and product analysis
QP Release of products into Europe
Method development and validation
Stability Testing
ICH compliant storage
Dissolution testing
Almac Clinical Services, Durham employs pharmacists as Project
Managers and provide the following additional clinical
services:
Provide clinical input
Write or review CTM section of the protocol
Communicate with all sites on all CTM issues
Design labels and drug kits from protocol specifications
Training of sites on drug reconstitution and administration
procedures
Clinical on-call services for CTM issues
Make presentations at monitor training and investigator
meetings
Prepare patient and site educational materials
Clinical Supply Management
For North American Enquiries
25 Fretz Rd.
Tel: (215) 660-8500clinicalservices@almacgroup.com http://www.almacgroup.com/clinical-trial-supply/
4204 Technology Drive
Tel: (919) 479 8850clinicalservices@almacgroup.com http://www.almacgroup.com/clinical-trial-supply/
For European and Global Enquiries
9 Charlestown Road
Tel: +44 (0) 28 3836 2436clinicalservices@almacgroup.com http://www.almacgroup.com/clinical-trial-supply/
Catherine Snyderwww.almacgroup.com/clinical-trial-supply/ View Map Contact Company
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