Investigational Drug Service

The Investigational Drug Service (IDS) is a licensed pharmacy that provides support and guidance for the safe and efficient conduct of clinical drug trials. Staffed by licensed research pharmacists and technicians who are specially trained in the research process, the IDS ensures the delivery of high-quality pharmaceutical care by adhering to federal and state regulations, accreditation standards and institutional policies for investigational drug control.

Services

In addition to providing investigational site pharmacy services, the IDS is experienced with providing coordinating pharmacy services for multicenter trials. The following services are offered upon request:

  • Study design and protocol development assistance
  • Dispensing and destroying study drugs or returning study drugs to sponsors
  • Randomization and development of blinding systems and placebos
  • Labeling and packaging of investigational products
  • Central/coordinating pharmacy services for multicenter trials
    • Protocol development
    • Drug and placebo formulation development
    • Pharmacy manual and documents development
    • Multisite drug distribution and monitoring for IND protocols
    • Training site pharmacies on protocol required pharmacy procedures
  • Secured drug storage areas that are monitored and alarmed to ensure proper storage conditions
    • Room temperature: 15-25°C
    • Refrigerators: 2-8°C
    • Freezers: -20°C and -80°C
    • Liquid nitrogen freezer
  • FDA IND application development assistance
  • Concomitant medication coding (using WHO Drug Dictionary)

Help prior to IRB submission

If you are an investigator or study coordinator preparing to submit your study to the Institutional Review Board (IRB), please contact the IDS before IRB submission. IDS staff can help ensure the services you need can be provided.

Location and Hours

The IDS core is located in the Mountain Pharmacy at Seattle Children’s hospital campus. IDS staff are available from 8 a.m. to 4:30 p.m., Monday through Friday, and research pharmacists are available after hours by pager for urgent issues.