A

Owners

Goods & Services

Regulatory affairs, namely, reviewing standards and practices to assure compliance with clinical trial laws and regulations; Providing independent review of clinical trials involving human subjects, namely, reviewing research protocols and related information to ensure protection of the rights and welfare of human subjects of research

Business consulting and management in the field of clinical trials in all phases as it relates to pre-study document collection and review, site selection, visits and audits, site compliance, project tracking and monitoring reports, negotiation and administration of investigator grants and clinical trial budgets and contracts, financial and management accounting, distribution, coordination and tracking of clinical trial products and materials, regulatory document processing, laboratory selection and coordination; Business consulting and management in the field of clinical trials in all phases as it relates to managing site and study-specific subject recruitment strategies and programs in the nature of contingency strategies and solutions to address specific project challenges; Business consulting and management in the field of clinical trials in all phases as it relates to managing the development of all study related documents and materials in the nature of study protocols, contracts, budgets, amendments, paper and electronic case report forms, informed consent forms, safety narratives, presentation posters, and training manuals; Business consulting and management in the field of clinical trials in all phases as it relates to managing all aspects of study, drug reconciliation, and inventory and distribution reports; Business management for all aspects of clinical trials in all phases as it relates to managing investigators, coordinators, monitors, technicians, and participants for compliance with clinical protocols and regulations; Business consulting and management in the field of clinical trials in all phases as it relates to management and compilation of computerized databases in the field of clinical trials for business purposes; Business consulting and management in the field of clinical trials in all phases as it relates to ethical reviews, namely, submitting clinical trial protocols to institutional review boards and independent ethics committees on behalf of medical, biopharmaceutical and biotechnology companies to assist them with clinical trials; Statistical analysis and reporting services for business purposes in the field of clinical trials; Business project management in the field of clinical trials in all phases as it relates to organizing and conducting business meetings of clinical trial investigators; Business management, namely, managing randomization logistics, in the pharmaceutical and biotechnological field for business purposes; Development and implementation of personnel recruitment and retention programs for investigators, coordinators, monitors, technicians and participants for use in clinical trials; Business consulting and management in the field of clinical trials in all phases as it relates to the administration of protocols involving volunteer research patients and the recruiting of such volunteer research patients; Providing data management services in the medical, pharmaceutical and biotechnological field for business purposes

Medical and scientific research consulting services for others in the field of design, planning, and implementation of clinical trials in all phases; providing quality assurance services in the pharmaceutical and biotechnological industries