Regulatory Interaction for CRISPR-Mediated Gene Therapy: Data Preparation and Reporting
Before transfer to a clinical environment, CRISPR-edited gene therapies are subject to internal and external regulatory audits. Clinical expansion for patient treatment requires data reporting and analysis to ensure processes are followed and data are recorded. GxP-ready functionality and full documentation of CQAs provided by the Genedata Biopharma Platform prepare those developing CRISPR-mediated gene therapies for regulatory submission. Generate reports and concatenate data captured in IDBS Polar Biopharma Lifecycle Management software, saving time and delivering a complete data set for Pre- and Post-IND filings.