Embleema and CDISC Partner to Develop Standards for Cell and Gene Therapy Product Monitoring

Embleema and CDISC Partner to Develop Standards for Cell and Gene Therapy Product Monitoring

May 24, 2022 by Business Wire Health News

Key Facts

  • METUCHEN, N.J. & AUSTIN, Texas--(BUSINESS WIRE)--Embleema Inc. and CDISC have announced a collaboration to develop new standards for experimental assays and bioinformatics protocols to facilitate monitoring the activity of Cell and Gene Therapy Products (CGTP).
  • “Embleema’s innovative work, combined with CDISC’s established processes and procedures, will benefit the clinical research community and, ultimately, patients greatly.”

  • The collaboration will cover standards development in three areas: Protocols for experimental assays and bioinformatics pipelines for evidence generation and submission to the regulation bodies Provenance and privacy with relation to the patient CGTP datasets * Longitudinal data linkage and patient engagement These new standards are intended to drive operational efficiencies, expediting the regulatory review process and reducing the time it takes to bring safe and effective treatments to market.
  • “We are grateful for the opportunity to partner with CDISC Platinum Member Embleema in developing standards that will meet a crucial need,” said Rhonda Facile, VP, Partnerships and Development, CDISC.

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