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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

Why should you go for Clinical Trail Management System??

Global Clinical Trial Management Systems Market valueation $1300.4 Million by 2016.It may increasing day by day and  now time is coming to increase your position for better future.

The report “Clinical Trial Management Systems (CTMS) Market: Global Trends, Opportunities, Challenge and Forecasts (2011 - 2016)”, as the name suggests, analyzes and studies the major market drivers, restraints, and opportunities in North America (U.S. and Canada), Europe, Asia, and Rest of the World.

 

Clinical trial is a medical research study that is performed in humans to check the safety and efficacy of drugs, devices, and therapeutic products before they are launched into the market for patient use. Clinical trials are very crucial as they involve huge capital investment and may affect the subjects involved. Thus proper management of clinical trials has become a priority for the hospitals.

Clinical Trial Management System caters these needs of clinical trial players as CTMS is employed to manage the large amounts of data involved in a clinical trial. It maintains the planning, preparation, performance, and reporting of clinical trials, including participant information, trial and filing deadlines and other important milestones. The global CTMS market is estimated to grow at a CAGR of 14.53% during the study period (2011-2016).

In this report, the global CTMS market is studied by the end-users, delivery mode, components, and types through various geographies. North America is leading the global CTMS market with around 62% share in 2010, as majority of the global clinical trials are conducted in North America, especially in the U.S. (around 58.5% share).
The U.S. is the largest market, and shows a remarkable growth opportunity. The second largest market, Europe, while growth in the Asia-Pacific region is also expected to take greater curves in the near future.

Major players in the Clinical Trial Management Systems Market include Oracle Corporation (U.S.), Perceptive Informatics (a subsidiary of Parexel International Corporation) (U.S.), Medidata Solutions (U.S.), eResearch Technology Inc. (U.S.), and BioClinica Inc. (U.S.).

Clinical Trial Management System:

A Clinical Trial Management System, also known as CTMS, is a customizable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of datainvolved with the operation of a clinical train. It maintains and manages the planning, preparation, performance, and reporting of clinical trials, with emphasis on keeping up-to-date contact information for participants and tracking deadlines and milestones such as those for regulatory approval or the issue of progress reports. Often, a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial managers.

In the early phases of clinical trials, when the number of patients and tests are small, most managers use an in-house or home-grown program to handle their data. As the amount of data grows, though, organizations increasingly look to replace their systems with more stable, feature-rich software provided by specialized vendors. Each manager has different requirements that a system must satisfy. Some popular requirements include: budgeting, patient management, compliance with government regulations, and compatibility with other data management systems.

Each sponsor has different requirements that their CTMS must satisfy; it would be impossible to create a complete list of CTMS requirements. Despite differences, several requirements are pervasive, including: project management, budgeting and financials, patient management, investigator management, EC/IRB approvals, compliance with U.S. Food and Drug Administration (FDA) regulations, and compatibility with other systems such as data management systems, electronic data capture, and adverse event reporting systems.