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Goods and Services Information
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Description:
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(1) - 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 reimbursement services, namely, providing business advice and information relating to reimbursement strategies and support to companies involved in the healthcare field.
(2) - 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.
(3) - 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.
(4) - 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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