Pharmacy

qpharm_pharmacy

Q-Pharm's team of experienced early phase clinical trial pharmacists and technicians gives you peace of mind through a comprehensive suite of pharmacy specific services, including but not limited to:

  • Review and advice on feasibility of the proposed trial in relation to the Investigational Medicinal Product (IMP)
  • Review and advice on development of the pharmacy manual
  • Development of the pharmacy manual
  • Provision of documentation for dispensing and accountability
  • Timely dosing and close control of (IMP)
  • Dedicated on-site storage with 24/7 temperature monitoring for room temperature and humidity - refrigerators (2-8˚C) and freezers (-20˚C and -80˚C).
  • Provision of a validated out-of-hours service to manage potential temperature variations.
  • Dispensing pre-formulated IMP into suitable containers, including provision of volunteer specific labelling in accordance with relevant safety and regulatory requirements
  • Complex compounding and dispensing of IMP in Q-Pharm’s Extemporaneous Compounding (EC) unit, including preparation of small dose capsules
  • Dedicated Class II Type A2 Biosafety cabinet for preparation of injectable dose forms
  • Genetically Modified Organism (GMO) storage, preparation, and dispensing
  • Long term storage for IMP
  • Destruction or return of IMP
  • Management of transfer of Documentation to the Trial Master File