Steps Toward a Successful Clinical Trial Management System

As the importance of translational research continues to grow, with focus placed on comparative effectiveness and outcomes-based research through translational science awards¹ and the American Recovery and Investment Act², 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 research trials.^3,4 The products of this investment have increased the number of clinical research trials being conducted simultaneously, as well as the number of investigational products (including devices and biologics) being tested has increased. This combined effort has place a compliance burden at academic research institutions or academic health centers.⁵ 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 (CTMS)

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 CTMS.  CTMSs are designed to be customizable enterprise-wide solution to manage, collect, and analyze data collected during the entire pre-clinical and clinical trial process. The benefits of mapping and developing an enterprise wide solution include

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• Centralizing decentralized departments

• 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 list below highlights some of the operational, infrastructure, compliance, and governance issues that can be improved by implementing a CTMS:

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

• Communication: improved communication will improve patient satisfaction and monitoring of clinical trials.

• Human error: CTMSs have integrated checking components to limit errors in reporting.

• Operational flow: improved knowledge flow in various divisions (finance, marketing, administration, training, and recruitment) will help to achieve real-time results and data.
• Managing clinical 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.⁷ 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. Establishing priorities and identifying current systems can be done in mapping sessions. In a mapping session, 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 weight 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).

Table 1 illustrates a typical mapping exercise. 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 analysis will help to identify the best CTMS fit for the institution.

After mapping system requirements and establishment of priorities are completed, 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.

Sample mapping grid (illustration only)

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 the 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)

• Searchable clinical trial database

• Analytical risk-based decisions

• Reporting dashboards

• Data warehousing module

• Recruitment support module

• Electronic case report form (eCRF)

• Integrates easily with electronic medical records (EMRs), 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 of your needs.

Cost factors and implementation overview

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 phase and implementation phase 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:

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

• Forecasting future issues: know the current and future issues of the institution that hope to be resolved with the CTMS.

• Adapting to change: 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.

• Training and preparation: 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.

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

Conclusion

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 pre-clinical and clinical research processes together. This integration creates a powerful database for clinical trials management enabling AMIs access to real-time data allowing them to maintain and manage various stages of clinical trials through CTMS data analytics.

A successful CTMS connects all aspects of clinical trial management and allow administration to focus on making strategic decisions based on analytics and accurate real-time data. Along with strategic, governance and operational improvements, a successful CTMS can improve patient satisfaction, increase return on investments ROIs, enhance communication between departments, increase the volume of completed trials, and generate an overall more efficient clinical research portfolio.

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

About the authors

Erika Stevens is a Senior Manager in the Advisory Services practice of EY. Erika has more than 18 years of academic medical center, hospital and clinical research experience, including more than 15 years in clinical research management serving in roles, such as the director of the Clinical Trials Office, regulatory training manager, director of clinical research and director of research operations. Erika is the chair of the editorial advisory board for The Monitor, the peer-reviewed journal publication for the Association of Clinical Research Professionals, and she serves on the Global Conference Planning Committee.

Christina Eberhart is a Manager in the Advisory Services practice of EY. She has more than 13 years of clinical research experience, contributing in such roles as director of clinical operations, director of quality assurance, clinical research associate, manager of quality assurance and the principle of an investigator trial network. Christina is a national speaker on several clinical research topics for the Association of Clinical Research Professionals, Drug Information Association and MAGI.

Jim Moran

is an Executive Director in the Advisory Services practice of EY with more than 18 years of experience working with universities, hospitals, academic medical centers and cancer centers as a research operating officer, chief compliance officer and consultant. Jim’s deep industry background includes developing multi-million dollar growth platforms for translational research and helping health care organizations improve clinical research operations, improve quality of care, manage regulatory risk and identifying innovative opportunities for leading research organizations to capitalize on their clinical research strengths. Jim is a frequent presenter at national and regional conferences on clinical research operations and regulatory compliance topics.

References

1. CTSA Home Page |” Clinical & Translational Science Awards Portal.” ─ https://www.ctsacentral.org/

2. "NIH and the American Recovery & Reinvestment Act (ARRA).” -  http://recovery.nih.gov/

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/EDCContract ─  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

Additional references

“Press Center - American Hospital Association.” ─ http://www.aha.org/press-center“NOT-OD-11-109 - NIH - National Institutes of Health.”─- http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-109.html
“Frequently Asked Questions - Nih - National Institutes of Health.” - http://grants.nih.gov/grants/policy/coi/coi_faqs.htm
Journal of Ahima -Californian Sentenced to Prison for HIPAA Violation  http://journal.ahima.org/2010/04/29/californian-sentenced-to-prison-for-hipaa-violation/

Columbia discovers fiscal benefits with clinical trial oversight,” HealthImaging.com, 14 April 2010, 
http://www.healthimaging.com/index.php?option=com_articles&view=article&id=21620&division=hiit.