35 Business consultation in the nature of business research support and research regulation compliance services including institutional review board review and oversight; business consulting, namely, clinical trial support services including coverage analysis and budget development for business purposes, clinical trial agreement development and negotiation, and research billing and collections; business administration of institutional biosafety committees; good clinical practice (GCP) auditing of clinical trials; research study monitoring to confirm accuracy of study data and compliance with the study plan for business purposes; and consultancy in the field of human research protection consulting to academic medical centers, health systems, hospitals, universities, researchers, pharmaceutical and device companies, and biotechnology and digital health companies to facilitate compliance with the regulations and guidance set forth by FDA, OHRP, NIH and other governmental agencies.
Trademark: 98137183
