Clinical Supply Management

PPD provides complete management of medical and pharmaceutical supplies through International Conference on Harmonisation (ICH)- and Good Manufacturing Practice (GMP)-certified contract houses or PPD-owned distribution centers on behalf of our clients. All vendors are audited by PPD to assure GMP compliance.

Storage and Distribution

Drugs can be dispensed directly from GMP-certified contract houses or PPD distribution centers to the investigational site or dispatched to regional offices for storage and further distribution. This process ensures that drug supply accommodates enrollment without incurring waste of study drug.

Services

Primary and secondary packaging services are available through ICH and GMP-certified contract houses and include bottling, blister packs, liquid fill, over-encapsulation, labeling, kitting, controlled substances II-V and antibiotics. Our services include the following:

• Project Management
  Inventory and distribution tracking and monitoring
  Labeling and packaging design assistance
  Sourcing and purchase of comparator products (contractor obligation/PPD management)
  Voice response (IVR) management of clinical trial supplies
  Placebo capsules, tablets and inhalers (contractor obligation/PPD management)
  Granulation of tablets for capsule filling (contractor obligation/PPD management)
• Primary packaging (contractor obligation/PPD management)
  Solid, semisolid and liquid dosage forms
  Over-encapsulation
  Physician samples
  Controlled substances II-V
  Cephalosporins and penicillins
• Secondary packaging (contractor obligation/PPD management)
  Label and kit design
  Multilanguage label text
  Multiple blinding methods
• ICH-compliant storage (contractor and/or PPD)
  Temperature-controlled warehouses
  Controlled environmental chambers
  Refrigeration and freezer storage down to -85 degrees Celsius
• Distribution (contractor and/or PPD)
  Global distribution
  Ambient, frozen and refrigerated shipping conditions
  Assistance with import/export licensing
• Drug accountability and destruction (contractor and/or PPD)
  Reconciliation of returned products to the client's specifications

Global Capabilities and Services

Our clinical supply distribution centers are in Australia, South Africa, Latin America and Europe, and work with ICH and GMP-certified contract houses as necessary for distribution of clinical supplies in other regions around the world. The PPD distribution centers located in Belgium and Brazil have cold chain capabilities.

In Europe, PPD has a Qualified Person (QP), experienced and trained in the European Union (EU) QP requirements, who can release clinical supplies from the Belgium facility. This facility features an indoor dispatch area, electronic safety and environmental monitoring, power backup systems, walk-in refrigerators and computer systems to track and dispatch supplies.