It is with great pleasure that we just learned that, after a long and demanding review process the FDA (US Food and Drugs Administration) has decided to grant approval of a new highly innovative and revolutionary drug by a major pharmaceutical, for which Agilis has contributed the meta-analysis of clinical trials and the elaboration of the statistical part of the application submitted to FDA.
The preparation of a regulatory submission for a new drug in the US is a very demanding process and includes hundreds of pages of clinical and statistical reports, clinical study data and statistical analysis for the efficacy and safety of the drug, combining the results of several clinical studies.
For our statistical team it required more than a year of hard work for statistical programming and statistical analysis under very strict deadlines, demanding regulatory constraints and scientific quality requirements, knowing that our work would be scrutinised by FDA reviewers and feeling the responsibility we had towards our customer and the safety of patients.
We are proud that we managed to contribute our scientific know-how to our customer’s success, that will improve the lives of ten million patients each year in the USA. For us this success is a milestone in achieving our vision of excellence, offering high quality statistical services for demanding clinical trials and we are grateful for the trust our customer and partners have shown to us and the opportunity they gave us to contribute to this innovative endeavour.