We use Advarra and WCG IRB for Institutional Review Board (IRB) for review and approval of all study protocols, specific study documentation, and donor-facing information. These organizations operate in compliance with FDA, OHRP, and International Conference on Harmonization (ICH). We operate under an electronic informed consent process which executes 21 CFR part 11 compliant e-signatures. Our systems interacting with study participants are HIPAA-compliant, and we have three ISO certifications: ISO 27001, ISO 27701, and ISO 9001. More information can be found here on our quality and compliance.