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
- GMP compliant 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