We offer a complete service to internal and external investigators carrying out clinical trials of investigational medicinal products. The department complies with current regulatory standards and legal requirements, and specialist clinical trials staff are GCP certified. We can provide advice at all stages of clinical trial planning and implementation, ensuring that pharmaceutical issues are identified and acted on at an early stage.
- Advice on protocol design, particularly to ensure that drug presentation, supply, storage, preparation and distribution meet current legal and professional requirements.
- Advice on sourcing of investigational medicinal products including placebos, blinding, randomisation, prescription and label design, relabeling and drug accountability.
- Basic randomisation including stratification (but not minimisation).
- Monitoring of adherence to pharmaceutical criteria, such as previous or concurrent drug treatment.
- Preparation and advice on administration of individualised dose units, including aseptic products.
- Distribution of investigational medicinal products to participating sites where STH is the Sponsor.
- Comprehensive documentation to GCP standards of all aspects of product handling and accountability.
- Ensuring that IMPs are appropriate for use and are procured, handled, stored and used safely and correctly.
- Ensuring that IMPs are managed and dispensed (including aseptic dispensing) to patients in accordance with the protocol.
- Accounting for all IMPs, including returns, in compliance with requirements.
- Ensuring that all pharmacy clinical trials procedures comply with relevant guidelines and regulations.
Please copy your R&D Coordinator into all correspondence with Pharmacy and remember to always include your STH reference number.
Royal Hallamshire Hospital contact
Northern General Hospital contact
Weston Park Hospital contact