Embleema
Embleema is a health technology company providing software for study sponsors to generate regulatory grade evidence for precision medicine health products, including Cell and Gene Therapy Products (CGTP). The FDA uses our bioinformatics platform to review the biotech’s evidence and support the agency’s regulatory decisions. Very often, based on our HIVE analytics, FDA will bring forward questions on the sponsor’s assays, bioinformatics protocols and point out discrepancies, leading to months of iterations with the sponsor and delaying the regulatory approval. By using Embleema, CGTP biotechs accelerate their product development and regulatory approvals and unlock clinical holds. Embleema has also partnered with CDISC, the international consortium for clinical data standards, to define standards for CGTP evidence generation (https://www.cdisc.org/news/embleema-and-cdisc-partner-develop-standards-cell-and-gene-therapy-product-monitoring).
