GIV·IN PV GIVINOSTAT IN POLYCYTHEMIA VERA

Management of business projects, namely management of clinical trial projects, recruitment and selection of personnel and experts for clinical trials, business management of clinical trials, arranging service contracts for others; records management services, namely indexing of documents for third parties, especially coordination and control of electronic and paper document flow; data management services to be used in the following fields: pharmaceutical drug development namely preparation of case report forms (CRFs); collection and compilation of data into a central storage in the following fields: clinical trials; compilation and provision of statistical and biostatistical information; medical coding services for third parties, namely coding of clinical trial data for the purposes of medical science and of regulatory reviews and approvals; compilation of data for the purpose of medical science research and medical consultation; regulatory document submission management, namely compiling dossiers in electronic common technical document or common technical document formats, annual reports, management of article submissions.

Education; training; organization and execution of conventions, events, congresses, seminars, conferences, symposia, exhibitions; publication of texts; on-line publication of books and specialized magazines; multimedia publication of magazines, specialized magazines and newspapers; arranging and organization of meetings, workshops and events; regulatory document submission management, namely publishing presentations.

Scientific and technological services; scientific services and research related to the same; scientific services and design related to the same; platform as a service [PAAS] comprising software platforms for the transmission of images, audiovisual content, video content and messages; scientific research for medical purposes; research services, design and development of instruments for control and diagnostics; computer diagnostic services, computer analysis services; scientific research; electronic data storage; technical writing, namely medical writing services for the development of medical protocols, clinical study reports, researcher pamphlets, safety reports, informed consent forms, meeting summaries, posters, manuscripts, study diagrams, manuals, and literature reviews; providing online non-downloadable software featuring clinical study and clinical trial management system tools via a website; electronic storage of files and documents; providing online non-downloadable software featuring study management files; programming of software for study management files; electronic storage services for archiving temporary files throughout the clinical study lifecycle; scientific research, namely programming of software for biostatistics, development of protocols for sample size and statistical power calculations, randomization plans, statistical analysis plans, programming of software for validation in a statistical analysis system, providing online non-downloadable software enabling interpretation and reporting of data for clinical trial reports and publications, product development for others; scientific research, namely intermediate analysis for early decision making, providing online non-downloadable software featuring database and data lists ready for a New Drug Application (NOA), regulatory submission-compliant data files, study data tabulation and data on model regulatory submission standards; medical research and development for new products for others in the field of medical surveillance and safety plans, ongoing oversight of patient-level studies and review of safety data, interpretation of study protocol, consultation on potential safety and medical issues and 24/7 medical surveillance coverage; drug development; drug discovery of adverse events from clinical trials, development of safety update reports and other aggregate reports, development of management safety plans and medical surveillance plans; quality testing of clinical trial's documentation, for example, standard operating procedures (sops) and work instructions, internal system reviews, site audits, provider evaluations; medical research in the following areas: pharmacology namely simulation, dose selection and optimization, biomarker and endpoint selection, study design optimization, population pharmacokinetic and pharmacodynamic modeling, exposure response modeling; medical research; information related to scientific and medical research in the area of clinical trials, namely the design of clinical trials and outcome measures for studying human diseases, or studying or testing drugs, devices, or medical treatment methods on humans; conducting clinical trials for third parties studying human diseases, or studying or testing drugs, devices, or medical treatment methods on humans; custom computer programming related to the following fields: image training and integration into computer systems of suitability data with interactive response technology (IRT); design and development of computer databases for the collection, storage, management, analysis and validation of data for use in the medical and pharmaceutical fields; electronic storage services for archiving presentations.

Regulatory compliance consultancy, namely legal assistance to third parties in drafting and compiling applications for new drugs, legal services relating to the submission and life cycle management of clinical trial applications to competent authorities, to ethics committees and to regulatory agencies, legal assistance concerning submission of amendments to applications.