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Goal: The Society of Clinical Research Associates (SoCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this program is to assist clinical research site administrators, managers, system users, investigators, nurses, other researchers and financial personnel in evaluating Clinical Trial Management System (CTMS) capabilities and benefits. Participants will learn basic technical terms and concepts related to Clinical Trial Management Systems. The program will teach individuals how to evaluate their organization in order to determine their CTMS requirements and to begin implementation. Revenue management, financial reporting and budgeting will also be discussed.
Objective: The goal will be accomplished through lecture, case study and practical application facilitated by clinical research professionals. Information and practical application recommendations will be presented and discussed regarding Clinical Trial Management Systems, CTMS evaluation, selection, implementation and management.
Learning Objectives:
Upon completion of this course the attendee should be able to:
- Discuss Clinical Trial Management System capabilities and how to assess the needs of a site
- Discuss and build requirements matrices and customized score card for selecting a CTMS
- Discuss the underlying data structures of CTMS products, including terms and concepts
- Discuss the role of CTMS in evaluating study feasibility processes
- Discuss budgeting terms and how CTMS can assist with clinical trial budgeting
- Discuss methods for reconciling a site’s financial requirements with sponsor’s budgets and how CTMS can effectively manage this process and aid the site in revenue management and financial reporting
- Discuss how workload scheduling and review processes support each other and how a CTMS can facilitate these management processes
- Discuss the planning and organization that is necessary to bring a CTMS into production and how involving the stakeholders can help ensure success
- Evaluate the costs and benefits involved in CTMS implementation
- Discuss how StudyManager software can help sites organize, centralize and manage research by reducing data-entry time, empowering staff, delivering critical recruitment and financial support
- Discuss how mdlogix Clinical Research Management System (CRMS) helps automate and improve compliance by providing a centralized place for managing the enterprise’s research processes
- Discuss how DDOTS CREDIT software can assist in clinical trials administrative tasks including tracking of patient schedules, simplification of record-keeping and reporting, patient notification regarding changing protocol information, and IRB-related activities
- Discuss how the Forte Research Systems’ Allegro family of products are easy-to-use, intuitively designed, cloud-based systems that support excellence in clinical research operations.
- Discuss how Macro’s IntelliTRIAL software can manage the financial aspects of research through budgeting, compliance tracking, invoicing, forecasting, and receipts/payments
- Discuss how Velos eResearch can provide comprehensive support as a clinical research management information system through clinical, administrative and financial products