42 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 pharmaceutical drug development; Compilation and provision of clinical study data, namely, compiling data for research purposes in the field of medical science and medical consultancy
Trademark: 90381096
