Christina Eberthart

	As the importance of translational research continues to grow, with focus placed on comparative effectiveness and outcomes-based research through translational science awards

 and the American Recovery and Investment Act,

 research institutions are exploring other options to remain competitive players in the academic clinical research arena. Among the options, many academic institutions are partnering with the federal government and industry to reinvest in bench research and clinical trials.

 The results of this investment have been an increase in the number of clinical research trials being conducted simultaneously, as well as a rise in the number of investigational products (including devices and biologics) being tested. This combined effort has placed a compliance burden at academic research institutes (AMIs) or academic health centers.

 To mitigate compliance issues and gain operational efficiencies, many academic centers are implementing clinical research software solutions to assist in managing the flow of information in their growing clinical research portfolios. 

Exploring the benefits of clinical trial management system

	As mentioned above, academic research institutions are assessing options to better control the flow of information and mitigate compliance issues in non-clinical and clinical research trials. One option for academic institutions is to implement a fully integrated clinical trial management system (CTMS).CTMSs are designed to be customizable enterprise-wide solution to manage, collect, and analyze data collected during the entire preclinical and clinical trial process. The benefits of mapping and developing an enterprise wide solution include:

		Optimizing institutional review board (IRB) functionality

		Realizing real-time data available to both investigators and leadership

		Decreasing bottlenecks in knowledge transfer between various entities involved in research

		Reducing human errors in reporting that often cause compliance issues

		Tracking milestones for grants, awards, fellowships, etc.

		Streamlining the financial structure-billing and invoicing

	By implementing a CTMS, AMIs are moving away from antiquated non-integrated manual processes and turning to technical solutions to manage the flow of information associated with conducting clinical trials.

	A successful CTMS can provide a well-organized flow of knowledge throughout the institution and assist senior management in obtaining real-time data to better analyze the current state of their clinical research enterprise. Armed with milestone-based, real-time data, senior management, such as business unit directors and department chairpersons, are better equipped to make strategic decisions to improve overall operational effectiveness, compliance, governance, and infrastructure (see Figure 1). The following list highlights some of the operational, infrastructure, compliance, and governance issues that can be improved through the implementation of a CTMS:


	Figure 1. CTMS impact in three key areas.

 With a better understanding of resources, management will be capable of reallocating staffing assignments to offset excess or inadequate roles.

 Improved communication will improve patient satisfaction and monitoring of clinical trials.

 CTMSs have integrated checking components to limit errors in reporting.

Improved knowledge flow in various divisions (finance, marketing, administration, training, and recruitment) will help to achieve real-time results and data.

More accurate and efficient reporting tools will be useful internally and externally for current and future project assessments.

Choosing a CTMS that serves your institutional needs

	There are three general types of CTMS: web-based, cloud-based, and on-site hosted-based software.

 Each type has distinct advantages and may have disadvantages depending on the IT infrastructure at the respective academic medical center. In order to understand your institutional needs, we suggest starting with defining the purpose or mission of your CTMS. Once the mission(s) or purpose is defined, then the disparate systems or system gaps can be assessed and mapped. During the mapping exercise, consider exploring the following missions and/or purposes to build use cases of a well-balanced, operationally efficient, and compliant CTMS:

		Improvements in clinical, administration, and financial management of research

		Fostering and improving collaborations among investigators

		Greater understanding of the progress and revenue impact of clinical trials

		Increasing subject recruitment and safety through the institution

		Reducing errors and increasing facility compliance

		Operating efficiently and saving research time					 	

	Prior to purchasing or implementing a CTMS, it is necessary to assess the institution's operational, compliance, and governance needs and priorities, as well as outline current software systems (see Table 1). Establishing priorities and identifying current systems can be done in mapping sessions. In these sessions, a cross-functional team of principal investigators, study coordinators, and senior leadership (such as the chief information officer, chief financial officer, human resources representatives, and chief compliance officer) are allowed to identify future system requirements, outline current software system gaps, and weigh operational, governance, and compliance priorities. For instance, leadership may insist upon certain compliance management reporting capabilities, while investigators may require that the system track pre-award study start-up milestones, financial reconciliation, and integrate with electronic health records (EHR). Next, a gap analysis of the research institute's current software system's capabilities and the requirements identified in the mapping sessions versus CTMS-specific capabilities is completed. The will help to identify the best CTMS fit for the institution.


	Table 1. Important considerations when choosing a CTMS.

	After this step, the vendor selection process can begin. Based on the mapping, most institutions will not be able to pick a system off the shelf that is fully operational for their clinical research needs. This makes choosing a system somewhat more complicated than implementing many other types of institutional systems, such as financial, electronic health management, and other point of service systems. CTMSs have the potential to solve many of the compliance, governance, operational, and managerial issues at academic medical centers with analytics and reports. So which system do you choose? Unfortunately, for these institutions, currently there are no perfect, one-size-fits-all CTMSs available in the market. Even though there is no perfect system, consider reviewing of some common elements among most of the best systems:

		Financial reporting tools (coverage analysis, residual and overage reporting)

		Clinical trial management tools (including applicable clinical trial milestones and reporting dashboards)

		Integrates easily with electronic medical records (EMRs), institutional review board (IRB) system(s), etc.

	As the market demand for computerized CTMSs increases, so does the number of systems solutions. Thus, we may be getting closer to a system that effectively manages all aspects of the clinical trial process at academic centers. Until then, any CTMS implementation will require a certain amount of mapping, customization, and implementation support, and may not serve all analytical and reporting needs.

	CTMSs can come with a hefty price tag. In our experience, the purchase and implementation of a CTMS often means a commitment of two or more years and costs can run into the millions of dollars. It is essential to take all implementation costs into consideration before choosing a CTMS. Many systems offer somewhat low "off the shelf" prices, but these prices don't reflect the true cost. It is necessary to consider not only the cost of the system itself, but the cost of customization, migration of data from legacy systems (EDC and data warehouses), integration with other disparate research (IRB, Lawson, EHR) systems, training, and roll-out timeline when choosing a CTMS. One other cost consideration is to engage a third party to assist during the system selection and implementation phases to provide program management for such a large investment.

	In our experience with the implementation of CTMSs, the following are key aspects of the process:

The most important aspect of implementing a CTMS is having a committee that is capable of making well-informed decisions for the institution.

 Know the current and future issues of the institution that hope to be resolved with the CTMS.

Understand that implementing a CTMS will come with new responsibilities. The institution should be prepared to have individuals fill these new roles. Without this preparation, the CTMS is doomed from the beginning. New hires might not be necessary, but rather a shift in responsibilities. Create a culture of transparency to eliminate conflict and inconsistencies in the future.

 Design an ongoing tailored training program to meet the short- and long-term needs of staff. Implement training and train staff on the new technology.

 Consider bringing in an unbiased firm to help people in the institution understand the true benefits of change. Theå firm can also provide management with options for implementation, interface, and utilization.

	In today's clinical research environment, it is no longer enough to have a disparate stand-alone system that tracks clinical trials. In reality, a successful CTMS solution will require integration with other systems such as EHR, IRB, and financials linking all preclinical and clinical research processes together. This integration creates a powerful database for clinical trials management, enabling AMIs access to real-time data and allowing them to maintain and manage various stages of clinical trials through CTMS data analytics.

	Along with strategic, governance, and operational improvements, a successful CTMS can improve patient satisfaction, increase return on investments, enhance communication between departments, increase the volume of completed trials, and generate an overall more efficient clinical research portfolio.

is Executive Director, all in the Advisory Services practice of Ernst & Young.

The views expressed are those of the authors and do not necessarily reflect the views of Ernst & Young LLP.

	1. CTSA Home Page, "Clinical & Translational Science Awards Portal." 

	2. "NIH and the American Recovery & Reinvestment Act (ARRA)." 

	3. "Sparking Economic Growth." The Science Coalition. 

http://www.sciencecoalition.org/reports/Sparking%20Economic%20Growth%20Full%20Report%20FINAL%204-5-10.pdf

	4. "Academic-Industry Partnerships for Biopharmaceutical Research." 

http://csdd.tufts.edu/files/uploads/tuftscsdd_academic-industry.pdf

	5. "Investing in Clinical Trial Compliance." Association of Academic Health Centers. 

http://www.aahcdc.org/policy/reddot/AAHC_Investing_in_Clinical_Trial_Compliance.pdf

	6. "EDC Focus: "Making The Right Investment In CTMS/EDC." 

http://www.contractpharma.com/issues/2009-11/view_features/edc-focus-making-the-right-investment-in-ctms-edc/

	7. "Clinical Trial Management Systems (CTMS) Market: Global Trends, Opportunities, Challenge and Forecasts (2011 - 2016)." 

http://www.prnewswire.com/news-releases/clinical-trial-management-systems-ctms-market-global-trends-opportunities-challenge-and-forecasts-2011---2016-138385234.html

Articles

As the importance of translational research continues to grow, research institutions are exploring other options to remain competitive players in the academic clinical research arena.

Christina Eberthart

Articles

Steps for a Successful Clinical Trial Management System