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Services >> Repackaging ProgramClinical TrialsTurn Key SolutionsAgency InventorySupport Services

 

   Clinical Trials Program

The Supply Service Center provides a comprehensive program for managing clinical trails. The center provides technical assistance, inventory management, and logistical support to meet the packaging and distribution requirements of clinical drug trials.

All services are provided in cooperation and sponsorship with the National Institutes of Health and other federal government agencies. The center must execute an inter-agency agreement with the prospective research programs in order to provide any clinical trial services.

The HHS SSC follows standard industry and FDA registered methods for receiving, sampling, testing, accepting, and repacking of all clinical supplies. Retention samples of clinical trial pharmaceuticals are retained and stored for the duration of the study.

The center has four high-speed packaging lines that produce unit-of-use containers of solid oral dosage forms. All packaging is accomplished using state of the art equipment and experienced personnel supervise all facets of the packaging.

Production controls include rigorous quality control standards performed by the pharmacy staff and the center’s quality assurance staff.

The center has over 40 years of experience in packaging, labeling and distributing investigational drugs for clinical trials. The scope of these trials has ranged from relatively small trials to large investigations involving clinical centers around the globe.

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Clinical Trials Services

  • Ordering, receiving and storing clinical trial supplies
  • Repackaging of clinical supplies into unit-of-use containers.
  • Custom labeling – design, development blinding, and printing. Multilingual text, graphics, and bar coding are available.
  • Refrigeration, Frozen and Controlled temperature storage.
  • Inventory management of supplies.
  • Traceable/reliable shipping to multiple clinical sites both in the US and global.
  • Return accountability and disposition of supplies.
  • Customized reports, order forms, and other documents provided as necessary.
  • Consultation on all aspects of repackaging, labeling, distribution, and procurement of clinical supplies.

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Past and Current Clinical Trials

SSC also continues to provide a comprehensive repackaging program for NIH and CDC sponsored clinical trials. Technical assistance, inventory management, and logistical support were provided to meet the packaging and distribution requirements of 11 clinical trials. In FY 2005 the Center entered into five new Interagency Agreements with respective research programs as the Drug Distribution Center (DDC). The current National Institutes of Health (NIH) and Center for Disease Control and Prevention (CDC) sponsored trials are the following:

Italian American Clinical Trial on Cataracts (NEI) 
Hepatitis C Clinical Trial for Thalessemia (NHLBI) 
Arginine Supplementation in Sickle Cell Anemia Trial (NHLBI) 
CombiRx Phase III Clinical Trial for Multiple Sclerosis (NINDS) 
BotUSA TB Project (CDC) 
Trial of Aldosterone Therapy in Adults with Preserved Ejection Fraction Congestive Heart Failure (TOPCAT) (NHLBI) 

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“The Supply Service Center has over 40 years of experience in packaging, labeling and distributing investigational drugs for clinical trials.”

 

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