ETHICA

Owners

Goods & Services

Clinical trial supplies management services, namely-customized drug packaging and labeling, central and site administered randomization and study supply distribution; developing and managing distribution and storage logistics for all clinical supplies, namely study drugs and devices, case report forms, study binders and all study related documentation; clinical trial management services, namely-pre-study document collection and review, site selection, pre-study site visits, initiation visits, monitoring visits, close-out visits, project tracking and monitoring reports, negotiation and administration of investigator grants, labeling, packaging, distribution, coordination and tracking of clinical trial materials, regulatory document processing, central laboratory selection and coordination; managing site and study-specific subject recruitment strategies and programs, namely contingency strategies and solutions to address specific project challenges; managing the development of all study related documents and materials, namely study protocols, amendments, paper and electronic case report forms, and informed consent forms; managing study operations/monitoring manuals in accordance with data management conventions, web-based data listings, namely adverse events, enrollment status, efficacy endpoints and paper and electronic study newsletters; management of tracking tools for enrollment, essential documents, monitoring, subject and case report form tracking, drug accountability, data queries and adverse events; managing all aspects of study drug reconciliation and inventory and distribution reports; managing all aspects of clinical trials, namely managing investigators, technicians, and participants, ethical reviews, investigator meetings, databases, statistical analyses and reporting, randomization logistics, medical writing services; recruitment of investigators, technicians and participants; providing strategies for recruitment of participants

Research services for clinical trials for others, namely conducting an ethical review of projects to protect the rights and welfare of research participants, developing study protocols, designing case report forms, developing participant screening tools, namely general and medical questionnaires, developing complete databases in accordance with strict guidelines, tracking of study parameters, providing statistical analyses, reporting and developing tracking tools for enrollment, essential documents, monitoring, subject and case report form tracking, drug accountability, data queries and adverse events; developing and implementing randomization logistics, namely randomization envelopes, customized blind-breakable drug labeling, code break management and reports, manufacturing of subject-and protocol-specific kits using bulk oral and topical medications; medical writing services, namely-drafting clinical study protocols, amendments, case report forms, informed consent forms, statistical analysis plans, full integrated clinical research reports, publications, abstracts and manuscript; developing site and study-specific subject recruitment strategies and programs, namely contingency strategies and solutions to address specific project challenges; developing study operations and monitoring manuals in accordance with data management conventions, web-based data listings, namely adverse events, enrollment status, efficacy endpoints and paper and electronic study newsletters

Study specific clinical personnel training programs for investigators, coordinators and investigator meetings; conducting investigator meetings