9
Computers, peripheral hardware components, namely external hard drives, flash drives, cables and video capture devices for converting signals from endoscopy machines to USB for storing on computers, said computers and peripheral hardware components comprising software configured according to study protocol requirements for receiving, storing and securely sending clinical study data, obtained from using imaging endoscopic procedures, over the Internet to a secure website
35
Recruitment and selection of investigators for clinical studies; managing relationships between vendors and subcontractors in relation to conducting clinical studies
38
Providing access to web portals for clinical study and clinical trials management system tools
41
Organization and planning of meetings, workshops and events relating to clinical studies
42
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 selection of clinical study sites, management of clinical study sites and clinical monitoring; Management of clinical trial documents, including coordinating and controlling flow of electronic and paper documents, secure storage and retrieval 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 services in relation to clinical research, including protocol development of sample size and power calculations, generation of randomization schedules, statistical analysis plans, statistical programming and validation in statistical analysis system, statistical analyses; Biostatistics and statistical programming services in relation to clinical research, including interpretation and reporting of data for clinical trial reports and publications, statistical and strategic consulting for product development, interim analysis for early decision-making; Biostatistics and statistical programming services in relation to clinical research, including integration of clinical databases and preparation of CDISC-compliant datasets and tables, listing and figures in support of regulatory submissions, and the provision of biostatistical consulting services, including adaptive design consulting and simulation support, and translational research support; Medical monitoring for clinical trials, 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 of clinical trial quality at investigator sites; Regulatory services in the field of clinical research, namely research and related consulting on the regulation of clinical trials; Monitoring of safety for clinical trial participants, 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 the preparation of 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; acquisition, assessment and quality control of medical images provided by others, including magnetic resonance images, endoscopy images, and histopathology images, for the purpose of clinical research and teaching
44
Medical imaging services