Class [42]
Computer & Software Services & Scientific Services
Medical writing services, including developing medical protocols, clinical study reports, investigator
brochures, safety reports, informed consent forms, meeting abstracts, posters, manuscripts, study charts,
manuals, literature reviews. Project management of clinical studies, including providing access to web portals for clinical study and clinical trials management system tools, recruitment and selection of clinical study sites and investigators, management of clinical study sites and clinical monitoring, managing relationships between
vendors and subcontractors, organization and planning of meetings, workshops and events. Document management, including coordinating and controlling flow of electronic and paper documents, secure storage and retrieval of electronic and paper documents, gas fire suppression with secure storage of electronic and paper documents, delivery of complete and inspection-ready trial management file (TMF), TMF setup,archiving and management through lifecycle of clinical study. Data management services including design of Case Report Forms (CRFs), custom programming of imaging adjudication and integration of eligibility data with Interactive Response Technology (IRT), database design and implementation, data validation, review and
cleaning, medical coding. Biostatistics and statistical programming, including protocol development of sample size and power calculations, randomization schedules, statistical analysis plans, statistical programming and validation in statistical analysis system, statistical analyses, interpretation and reporting of data for clinical trial reports and publications, statistical and strategic consulting for product development, interim analysis for
early decision-making, database integration, New Drug Application (NDA) ready data listings,
CDISC-compliant datasets, thought leadership and operational experience with CDISC standards (SDTM and ADaM), integrated safety and efficacy summaries, adaptive design consulting and simulation support, translational research support, data monitoring board management and support. Medical monitoring, including medical review of clinical study materials, preparation of medical monitoring and safety plans, continuous trial
oversight via patient level and safety data review, subject eligibility support for investigators, medical support to sites and study teams for interpretation of study protocol, consultation on potential safety issues and medical concerns, 24/7 medical monitor coverage. Monitoring and site management. Regulatory services. Drugs safety,
including processing adverse events from clinical trials, preparing Development Safety Update Reports
(DSURs) and other aggregate reports, performing signal detection and benefit-risk assessments, preparing safety management plans, preparing medical monitoring plans. Quality assurance, including quality assistance
documentation, such as Standard Operating Procedures (SOPs) and work instructions, internal system reviews, site audits, vendor assessments. Clinical pharmacology services, including dose simulation, selection and optimization, selection of biomarkers and endpoints, optimization of trial design, population pharmacokinetic
and pharmacodynamic modeling, exposure response modeling. Translational medicine, including
immunohistochemistry, flow cytometry, transcriptomics, proteomics, microbiome study.
Design of clinical trials and outcome measures for studying human diseases, or for studying or testing
drugs, devices or methods of medical treatment on humans in relation to diseases; conducting clinical trials which study human diseases, or study or test drugs, devices or methods of medical treatment on humans in relation to diseases; electronic medical
imaging support services for use in assessing patient health in clinical trials, namely reviewing and scoring electronic medical images, including video images, of patients supplied by others; histopathology support services, namely reviewing and scoring tissue sample images provided by others; magnetic resonance support services, namely reviewing and scoring magnetic resonance images provided by others; and endoscopy support services, namely reviewing and scoring endoscopic images provided by others.
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