CDISC and Embleema Inc. are collaborating to develop new standards for experimental assays and bioinformatics protocols to accelerate the development of availability of new cell and gene therapies for patients.
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
Once released, the standards will be freely available via the CDISC website.