AEST-ETHICA

Owner

Goods & Services

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 participant recruitment strategies and programs, 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; data management services (eCRF Data Fields, eCRF builds, data management plans, database lock, data visualization); Biostatistics services (statistical analysis plans, statistical programming/testing/validation, statistical reports); medical writing services (full integrated clinical research reports, publications, abstracts and manuscripts)

Contract research services for clinical trials, namely, conducting investigator meetings; clinical trial management services, namely, study-specific clinical personnel training programs for investigators and coordinators, investigator meetings

Contract research services for clinical trials, namely, developing study protocols, designing case report forms; developing complete databases in accordance with strict guidelines, cordinating ethics review submissions, developing and maintaining trial master file (paper or electronic), 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 blind breakable drug labelling, code break management and reports, manufacturing of subject- and protocol specific kits using bulk oral and topical medications; drafting clinical study protocols, eCRF Data Fields, eCRF builds, data management plans, database lock, data visualization, statistical analysis plans, statistical reports, full integrated clinical research reports, publications, abstracts and manuscripts