Spectratox Ltd is a Contract Research Organisation (CRO) which provides advice on the interpretation of laboratory data as well as the photosensitivity is in the business of clinical phototoxicity studies and in time laboratory photosensitivity testing to the pharmaceutical and health care sectors.
The sole shareholder of Spectratox Ltd is the Photobiology Trust, a charitable organisation devoted entirely to the promotion of dermatological research, education and clinical care.
The new venture, driven by the experience and reputation of Professor James Ferguson will operate to the highest industrial, regulatory and ethical standards offering first class phototoxicity testing with the capability of providing residential facilities which will be independent of the NHS.
The experienced team at Spectratox offers a seamless service where the quality of the analysis is combined with the ability to perform volunteer and additional post study scientific testing or research as necessary. Clinical phototoxicity trials are conducted on healthy volunteers using the drugs or product supplied by industry and tested for phototoxicity. The results will be analysed and reported back to the trial sponsor. Phototoxicity testing is carried out on the premises of the National Photobiology Unit of Ninewells Hospital and Medical School (part of NHS Tayside).
Full phototoxicity services comprise:
- Volunteer phototoxicity studies for topical and systemic drugs
- Laboratory photosensitivity testing
- Scientific input
- Study design
- Protocol production and review (in collaboration with sponsor)
- Ethics submission and approval
- Regulatory approval (if necessary)
- CRF design
- IMP management
- Subject recruitment and consent
- Dosing and sampling
- Phototesting and recording of results
- Accident and Emergency management
- Monitoring and Q&A
- Data management
- Interpretation of results
- Report production and review
Spectratox's company strengths and core competencies are:
- Key team members with 20+ years experience of patient phototoxicity and in conducting phase 1 phototoxicity trials and a proven track record with the pharmaceutical industry.
- Professor James Ferguson will the the Principal Investigator (PI) in Spectratox. He is a world renowned academic and clinician with significant publications in the field of photodermatology. His main areas of research interests are in the specialised area of phototherapy and photochemotherapy of skin diseases and clinical and laboratory study of drug induced phototoxicity, particularly fluoroquinolones; study of the natural history and treatment of the photosensitivity disorders.
- Access to phototoxicity testing equipment that is ISO9001 accredited.
- Ready access to emergency resuscitation services.
- Access to a large student population for creating the volunteer database.
- Ready access to a facility for housing volunteers on a residential capacity.
- If a compound is found to be photosensitive, scientific knowledge and expertise is available to modify it to limit the photosensitive effect without affecting its efficacy.
- A loyal, committed and passionate core team.