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. | Research compliance training; training in the field of human research protection to academic medical centers, health systems, hospitals, universities, researchers, pharmaceutical and device companies, and biotechnology and digital health companies | Software as a service (SAAS) services featuring software solutions, namely, software that provides structure and process for developing research protocols and informed consent forms, supports research operations process management and workflow management, including, automating, systematizing and structuring the administration and management of institutional review boards, institutional biosafety committees, and other areas of research compliance as well as business operations related to clinical trials | Research regulatory compliance auditing
Design and development of computer software for database management, document generation and management, cloud storage of data, business process management, workflow and event management and compliance management; Software as a service (SAAS) services featuring software for database management, document generation and management, cloud storage of data, business process management in the nature of smart online forms, process automation, and automated email notifications, workflow and event management in the nature of process automation and documentation of standard operating procedures and their execution, analysis of data, and reporting of data in the fields of research compliance, organizational governance and compliance, and regulatory compliance; Providing temporary use of on-line non-downloadable firmware for database management, document generation and management, cloud storage of data, business process management in the nature of smart online forms, process automation, and automated email notifications, workflow and event management in the nature of process automation and documentation of standard operating procedures and their execution, analysis of data, and reporting of data in the fields of research compliance, organizational governance and compliance, and regulatory compliance; Application service provider (asp) featuring computer software for database management, document generation and management, cloud storage of data, business process management in the nature of smart online forms, process automation, and automated email notifications, workflow and event management in the nature of process automation and documentation of standard operating procedures and their execution, analysis of data, and reporting of data in the fields of research compliance, organizational governance and compliance, and regulatory compliance; providing temporary use of online non-downloadable software for database management, document generation and management, cloud storage of data, business process management in the nature of smart online forms, process automation, and automated email notifications, workflow and event management in the nature of process automation and documentation of standard operating procedures and their execution, analysis of data, and reporting of data in the fields of research compliance, organizational governance and compliance, and regulatory compliance
Application service provider (ASP) featuring computer software for business process management and workflow management, namely, automating, systematizing and structuring the administration and management of institutional review boards; providing temporary use of online non-downloadable software for compliance management
