35
Business project management, That is, 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, In particular bathtubs, coordinating and controlling flow of electronic and paper documents; Data management services for use in the following fields: pharmaceuticals drug development, That is, preparation of Case Report Forms (CRFs), Collection and compilation of information into computer databases in the following fields: Clinical studies; Compilation and provision of statistical and biostatistical information
41
Teaching; Training; Arranging and conducting of conventions, events, congresses, seminars, conferences, symposia, exhibitions; Publication of texts; Online publication of specialist magazines and books; Multimedia publishing of magazines, journals and newspapers
42
Science and technology services; Scientific services and research relating thereto; Scientific services and design relating thereto; Platform as a service [PaaS] featuring software platforms for transmission of images, audio-visual content, video content and messages; Scientific investigation for medical purposes; Research, design and development of monitoring and diagnostic tools; Computer analysis, prediction and diagnostics; Scientific research; Electronic data storage; 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, trial management files (TMF), TMF setup, archiving and management of TMP files through lifecycle of clinical study; Research services, 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; Research services, Namely, 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; Research services, Namely, integrated safety and efficacy summaries, adaptive design consulting and simulation support, translational research support data monitoring board management and support; Medical research, Namely, medical surveillance and search site surveillance in the field of medical revision of clinical study materials, preparation of medical surveillance and safety plans, continuous monitoring of patient studies and revision of safety data; Medical research, Namely, support in subject suitability for researchers, medical support to sites and study groups for the interpretation of study protocols, consultancy on potential security problems and medical problems and 24/7 medical surveillance; Pharmaceutical drug development services; drug safety, In particular computer-assisted, 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 following fields: Clinical trials, namely, quality assistance documentation, For example, Standard Operating Procedures (SOPs) and work instructions, internal system reviews, site audits, vendor assessments; Medical research in the following fields: 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; 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; Conducting clinical trials for others which study human diseases, or study or test drugs, devices or methods of medical treatment on humans; Custom computer programming services, in relation to the following fields: 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 the following fields: medical field and Pharmaceutical field; Compilation of data For research purposes, in relation to the following fields: medical science and Provision of technical advice and consultation services; Medical coding for others, namely, coding of clinical trial data for purposes of medical science and regulatory review and approvals
45
Regulatory submission management, namely, assisting others in preparing and filing applications for new drugs with governmental 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; Regulatory submission management, namely, submission publishing and dossier compilation in electronic common technical document or common technical document formats, annual reports, paper submissions management and submission archival