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 (terms too vague in the opinion
of the International Bureau – Rule 13(2)(b) of the
Regulations); providing independent review of clinical
trials for business purposes (terms too vague in the opinion
of the International Bureau – Rule 13(2)(b) of the
Regulations); 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 reimbursement services,
namely, reimbursement strategies and support to companies
involved in the healthcare field
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 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 (terms
too vague in the opinion of the International Bureau – Rule
13(2)(b) of the Regulations); 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 (terms too vague in the
opinion of the International Bureau – Rule 13(2)(b) of the
Regulations)
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 (terms too vague in
the opinion of the International Bureau – Rule 13(2)(b) of
the Regulations); regulatory compliance consulting in the
pharmaceutical, medical, healthcare, and life sciences
fields (terms too vague in the opinion of the International
Bureau – Rule 13(2)(b) of the Regulations)
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