Almac Clinical Services

Almac Clinical Services provides a global service for the manufacture, packaging, labeling, distribution, returns and analysis of clinical trial supplies. Our cGMP facilities located in North America (Audubon, PA and Durham, NC) and in 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 sister company, Applied Clinical Technologies, web address, www.almacgroup.com.

• 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

2661 Audubon Road
Audubon, PA 19403

Tel: (610) 666 9500
Fax: (610) 666 9501
E-mail: clinicalservices@almacgroup.com
Web: www.almacgroup.com

4204 Technology Drive
Durham, NC 27704

Tel: (919) 479 8850
Fax: (919) 471 2633
E-mail: clinicalservices@almacgroup.com
Web: www.almacgroup.com

For European Enquiries

9 Charlestown Road
Seagoe Industrial Estate
Craigavon
BT 63 5PW
United kingdom

Tel: +44 28 3836 2436
Fax: +44 28 3836 3800
E-mail: clinicalservices@almacgroup.com
Web: www.almacgroup.com

Contact Information

Almac Clinical Services
Jonathan Calderwood, Global Marketing Manager
2661 Audubon Road
Audubon, PA 19403 USA
Phone: 610-666-9500
Fax: 610-666-9501
E-mail:

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