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; 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; medical records coding services for others in
the nature of assignment of diagnostic and procedural codes
for purposes of reimbursement from insurance and other
third-party payers; business consulting services in the
field of medical coding in the nature of assignment of
diagnostic and procedural codes for purposes of
reimbursement from insurance and other third-party payers;
providing administration of reimbursement services, namely,
providing business advice and information relating to
reimbursement strategies and support to companies involved
in the healthcare field
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
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, including orthopedic,
cardiovascular, dermatology, and aesthetics; 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 Food and Drug Administration (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
45
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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