|
Description:
|
(1) - Computers, peripheral hardware components, namely, blank external hard drives, blank flash drives, and video cables; video capture devices, namely, signal processors, video receivers and video recorders for converting signals from endoscopy machines to USB for storing on computers; Recorded video recording software, and downloadable video recording 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.
(2) - Business project management services, namely, project management of clinical studies, 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; Records management services, namely, document indexing for others, specifically, coordinating and controlling flow of electronic and paper documents; Data management services for use in pharmaceutical drug development, namely, preparation of Case Report Forms (CRFs), Collection and compilation of information into computer databases in the field of clinical studies; Compilation and provision of statistical and biostatistical information; Medical coding services for others in the nature of coding clinical trial data for purposes of medical science and regulatory review and approvals.
(3) - Technical writing, namely, medical writing services for developing medical protocols, clinical study reports, investigator brochures, safety reports, informed consent forms, meeting abstracts, posters, manuscripts, study charts, manuals and literature reviews; Providing an Internet website portal featuring clinical study and clinical trial management system tools; Electronic storage of files and documents, secure storage of electronic and paper documents; File sharing services, namely, providing a website featuring technology enabling users to upload and download electronic files, namely, complete and inspection-ready trial management files; Electronic storage services for archiving databases, images and other electronic data in the field of trial management files (TMF), TMF setup, archiving and management of TMP files through lifecycle of clinical study; Conducting scientific research, namely, biostatistics and statistical programming, 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, regulatory submission compliant datasets, thought leadership and operational experience with study data tabulation model and analysis data model regulatory submission standards, integrated safety and efficacy summaries, adaptive design consulting and simulation support, translational research support data monitoring board management and support; Medical research services, namely, medical monitoring and investigator site monitoring in the field of 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 and 24/7 medical monitor coverage; Pharmaceutical drug development services in the field of drug safety, specifically, 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 and preparing medical monitoring plans; Providing quality assurance services in the field of clinical trials, namely, quality assistance documentation, such as Standard Operating Procedures (SOPs) and work instructions, internal system reviews, site audits, vendor assessments; Medical research services in the field of pharmacology, namely, dose simulation, selection and optimization, selection of biomarkers and endpoints, optimization of trial design, population pharmacokinetic and pharmacodynamic modeling, exposure response modeling; Medical research services in the field of translational medicine, namely, immunohistochemistry, flow cytometry, transcriptomics, proteomics, microbiome study; Providing medical and scientific research information in the field of clinical trials, namely, the 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 for others which study human diseases, or study or test drugs, devices or methods of medical treatment on humans in relation to diseases; Custom computer programming of imaging adjudication and computer systems integration of eligibility data with Interactive Response Technology (IRT); Computer database design and implementation for data collection, data storage, data management, data analysis, and data validation for use in ph
(4) - Medical imaging services; Medical diagnostic testing, monitoring and reporting services; Medical imaging services, namely, 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; Medical imaging services, namely, histopathology support services for reviewing and scoring tissue sample images provided by others; Consulting services in the field of medical imaging, namely, magnetic resonance support services for reviewing and scoring magnetic resonance images provided by others; Medical services, namely, endoscopy support services in the field of reviewing and scoring endoscopic images provided by others.
(5) - Regulatory submission management, namely, assisting others with preparing and filing applications for new drugs with government regulatory bodies, submission planning and life cycle management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, pre-approval submissions, submission of supplements, amendments and variations applications, submission publishing and dossier compilation in electronic common technical document or common technical document formats, annual reports, paper submissions management and submission archival.
|