Clinical Trials Program
PSC clinical trials program can help manage the entire drug distribution process — including material acquisition, repackaging, inventory management, and transportation — to meet the most detailed clinical trial packaging and distribution requirements.
All PSC clinical trial program services are provided in cooperation and sponsorship with the National Institutes of Health and other federal agencies. This is accomplished by using state-of-the-art equipment and experienced personnel who supervise all facets of the packaging and distribution process.
PSC's clinical trial solution includes:
- Ordering, receiving, and storing clinical trial supplies
- Repackaging of clinical supplies into unit-of-dose containers
- Custom labeling — design, development blinding, and printing (multilingual text, graphics, and bar coding are available)
- Refrigeration, freezing, and controlled temperature storage
- Inventory management of supplies
- Traceable/reliable shipping to multiple clinical sites both in the United States and around the world
- Return accountability and disposition of supplies
- Retaining samples of clinical trial pharmaceuticals and storing for the duration of the study
- Customized reports, order forms, and other documents provided as necessary
- Consultation on all aspects of repackaging, labeling, distribution, and procurement of clinical supplies
- Distribution of material to required sites around the world.
PSC follows standard industry and Food and Drug Administration-registered methods for receiving, sampling, testing, accepting, and repacking of all clinical supplies. Production controls include rigorous quality control standards performed by the pharmacy staff and quality assurance staff. PSC has four high-speed packaging lines that produce unit-of-use containers of solid oral dosage forms.
PSC 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.