The Spectratox Team has developed substantial expertise in advising on the need or otherwise for phototoxicity studies of new drugs and compounds, as well as photoprotection studies.
Clinical phototoxicity trials test drugs or products supplied by industry in healthy volunteers. The results are analysed and reported back to the trial sponsor.
The Photobiology Unit employs an extensive Quality Management System with accreditation to ISO 9001:2015. We are regularly internally and externally audited by organisations such as the British Standards Institute (BSI) and the UK’s National Accreditation Body (UKAS). Accuracy of ultraviolet and visible light dosimetry is paramount with UV Detector Calibrations traceable to National Measurement Institutes in the UK and France and accreditation to ISO 17025:2005 (UKAS Accreditation Number 0639).
Full clinical trial services offered by Spectratox include:
- Scientific input
- Laboratory photostability, photosafety, phototoxicity and photogenotoxicity testing
- Healthy volunteer phototoxicity studies for topical and systemic drugs
- Study design
- Protocol production and review (in collaboration with sponsor)
- Case report form design
- Ethics submission and approval
- Obtaining Regulatory approval (if required)
- IMP (Investigational Medicinal Product) management
- Volunteer recruitment and consent
- Dosing and sampling
- Phototesting and recording of results
- Accident and Emergency management
- Monitoring and Quality Assurance
- Data management and analysis
- Interpretation of results
- Report writing and advice on product labelling and clinical management