35
Business consulting and management in the field of clinical
trials, namely, clinical data and regulatory submission
management on behalf of pharmaceutical, medical, healthcare,
and life sciences companies to assist them with clinical
research, clinical trials and applications for drug,
biologic and device approval; business analysis, namely
providing independent review of clinical trials for business
purposes; contract research organization (CRO) services,
namely, business management in the field of clinical trials,
namely, clinical data management
41
Contract research organization (CRO) services, namely,
custom writing for others for non-advertising purposes in
the nature of medical writing of clinical study protocols
and reports; consultation in the field of publishing and
issuing scientific papers in relation to conducting clinical
trials, regulatory affairs, drug development, manufacturing
compliance and validation, advanced technology, clinical
benchmarking and clinical performance improvement in the
field of international health and in the pharmaceutical,
biotechnology, and medical device industries
42
Contract research organization (CRO) services, namely,
monitoring of clinical trials for drugs, biologics and
devices of pharmaceutical, medical, healthcare, and life
sciences companies for quality control purposes, and
clinical trial project management in the nature of design
and implementation of clinical trials and quality assurance
for all major therapeutic areas, in particular
gastroenterology, nephrology, urology, and oncology;
consulting services in the field of conducting clinical
trials in the pharmaceutical industry, the biotechnology
industry and the medical device and diagnostics industries;
providing quality assurance services in the field of
regulatory submissions to the FDA by life sciences companies
to ensure validity and accuracy; product development for
others, namely, providing implementation services relating
to the development and validation of drugs, biologics and
medical devices; software as a service (SaaS) services
featuring software for accessing, collecting, managing,
tracking, analyzing, and reporting data and information on
clinical trials
45
Legal assistance services, namely 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; regulatory compliance consulting in
the pharmaceutical, medical, healthcare, and life sciences
fields
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