BayBiotech.NET I nvestigational Product consideration element in a Decentralized Clinical Trial: In any traditional clinical study, administration of the investigational product (IP) to the study participants should be performed under the supervision of the investigator or the delegate medical representative. If a clinical study is considering a decentralized clinical trial model, there are certain factors to be considered for IP administration. For IP that has a high-risk safety profile, especially in the immediate post administration period, may need on-site dose administration under close supervision of the protocol trained principal investigator. However, for IP with a defined safety and stability profile and with well-understood low risk characterization may be administered at local health care facilities, mobile research facilities or at study participant's home. Regardless, for an investigational product, a well-established chain of custody and well documented accountabilit...
BayBiotech.NET Mobile Health App Interactive Tool If you are developing a mobile health app checkout the interactive tool to figure out the federal regulatory, privacy and security laws that may apply to your App. More than regulations might be applicable depending on the scope but this website links all relevant regulations on FTC website. Link: https://www.ftc.gov/business-guidance/resources/mobile-health-apps-interactive-tool