Maxer organises the archiving of the Trial Master File for the Reparo study
Over the last weeks, Maxer organised the archiving of the Trial Master File (TMF) for the Reparo clinical study dedicated to the drug Oxervate, developed by Dompé and approved by EMA last July. Oxervate is indicated for the treatment of the neurotrophic keratitis, a rare degenerative ocular disease and is only used is in adults with a moderate or severe condition.
The activity Maxer put in place involved the analysis of the documents, the checking of the indexing system and the consistency between the paper and the electronic versions of the study documents.
Maxer also completed the archiving data sheets and the set of information needed to archive and consult the TMF efficiently.