Our wide-ranging experience from over 500 dermatology projects involving 9000 sites and almost 100.000 patients has given us an excellent understanding of trial designs, regulatory pathways, definition of endpoints and other key aspects for operational excellence.
TFS dermatology consulting unites a team of experts supporting clients in scientific-, medical-, regulatory- and commercial aspects of clinical development. Consulting is also provided to support our clients in any development and validation of Patient Reported Outcome measures in the field of dermatology. Our consulting services are usually involved well ahead of the clinical trial start.
Study Phase I & II: Clarification of key questions for the clinical development program and the substance validation, e.g. study design, safety reviews, dose finding investigation, dosage determination considerations and indication options.
Study Phase III: Optimal resource planning and outcome definitions to evaluate benefits of a substance, such as additional therapeutic effects on comorbidities. The TFS dermatology team has contributed to the development of more than 15 scores and questionnaires to address specific benefits of clients’ dermatology products.
Study Phase IV: Additional medical- and safety questions, e.g. chronic indications and compliance during long-term therapy, and real world evidence studies.