ethica CRO

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35 Commercial assistance services in respect of contract research services for clinical trials, namely recruiting investigators, providing strategies for recruitment of participants, screening participants; clinical trial management services, namely: pre-study document collection and review, site selection, pre-study site visits, initiation visits, monitoring visits, closeout visits, project tracking and monitoring reports, negotiation and administration of investigator grants, labelling, packaging, distribution, coordination and tracking of clinical trial materials, regulatory document processing, central laboratory selection and coordination; clinical trial management services, namely site and study-specific subject recruitment strategies and programs; clinical trial management services, namely contingency strategies and solutions to address specific project challenges, development of all study related documents and materials, namely study protocols, amendments, case report forms (paper or electronic), informed consent forms, study operations/monitoring manuals in accordance with data management conventions, web-based data listings, namely adverse events, enrollment status, efficacy endpoints, study newsletters (paper or electronic); management of tracking tools for enrollment, essential documents, monitoring, subject and case report form tracking, drug accountability, data queries, adverse events; clinical trial supplies management services, namely: customized drug packaging and labelling, randomization (central and site administered) and study supply distribution, developing and managing distribution and storage logistics for all clinical supplies (study drugs and devices, case report forms, study binders, all study related documentation); managing all aspects of study drug reconciliation and inventory and distribution reports; business operation in respect of medical writing services

41 Conducting investigator meetings in respect of contract research services for clinical trials; clinical trial management training services, namely study-specific clinical personnel training programs for investigators and coordinators, investigator meetings

42 Contract research services for clinical trials, namely conducting an ethical review of projects to protect the rights and welfare of research participants; contract research services for clinical trials, namely developing study protocols, designing case report forms; developing complete databases in accordance with strict guidelines, tracking of study parameters, providing statistical analyses and reporting; development of tracking tools for enrollment, essential documents, monitoring, subject and case report form tracking, drug accountability, data queries, adverse events; developing and managing randomization logistics, namely randomization envelopes, customized blindbreakable drug labelling, code break management and reports, manufacturing of subject- and protocol specific kits using bulk oral and topical medications; drafting clinical study protocols, statistical analysis plans, full integrated clinical research reports, publications, abstracts and manuscripts

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Markenform	Bildmarke
Aktenzeichen	019019260

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Markendetails Letztes Update: 13. Mai 2024

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