NeuroSense Therapeutics Ltd. (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pharmacokinetic study of PrimeC in healthy adult subjects.
“It is of immense importance to the whole ALS community for this program to develop as fast as possible. GCT is proud for providing our support towards the development of the new and promising therapy “, said Dr. Jeffrey T. Apter, GCT President.
A combination drug which aims to slow the progression of ALS was investigated in a number of studies showing promising results. Global Clinical Trials, LLC (“GCT”), a premier contract research organization with clinical services in the U.S., Europe, and Asia has worked with NeuroSense providing the regulatory and programming support for this IND application. GCT’s responsibilities included biostatistics and programming tasks involving generation of CDISC datasets for the FDA submission.
“We are thankful to the GCT team for assisting us in our submission and allowing us to meet timelines, while providing quality datasets for our submission. It was a pleasure to work with them”, said Avital Pushett, Head of ALS Clinical Program, NeuroSense Therapeutics.
If you have your trial data in the SAS or Excel or CSV format, GCT can help you with generating the whole CDISC package (converting it into SDTM / ADaM datasets) in eCTD format for FDA submission using SDTM Reviewer’s Guideline (SDRG), ADaM Reviewer’s Guideline (ADRG) etc., and to publish and prepare the submission package.