Selecting an Enterprise Research System

Transcription

1 Selecting an Enterprise Research System Three Steps to Evaluating and Choosing the Right Enterprise-class System for an Academic Medical Center, Research Hospital, or Cancer Center. By

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3 IIntroduction Defining an enterprise research solution and its benefits An enterprise research system (also commonly known as a clinical research management system or a clinical trial management system) is a software system used to manage all operational and clinical data involved with the administration of clinical trials. The use of an enterprise research system provides for easy, efficient organization of data in a centralized place so that trials can run more smoothly. Many institutions have already realized several benefits from the use of an enterprise system. The University of California, San Francisco, for example, chose to implement a new system in In that time, it s realized tremendous value: Time to open study has been reduced by more than half, resulting in a significant reduction in the cycle-time from IRB acceptance to the time a clinical trial has been opened. The financial billing council uncovered significant revenue in unbilled activities from industry studies, and the center cut operational costs, running cash-neutral. But to derive such great value from an enterprise research system, special care should be taken to select one that is right for your organization. To read more about UCSF s experience, download the case study: UCSF Recovers Significant Revenue, Cuts Operational Costs.

4 Are there specialized systems available? Yes, enterprise research systems can be specialized to support the varying complexities of research. There are many options on the market, and they all offer different functionality, based on whom they were designed for. Take, for example, the systems offered by Forte Research Systems. Forte offers two very different systems, each targeted toward a specific market: A comprehensive clinical research management system, OnCore Enterprise Research supports operations at academic medical centers, cancer centers, and health care systems. A cloud-based clinical trial management system, Allegro CTMS efficiently manages the operational data of clinical trials for dedicated research sites, physician practices, and community hospitals. Finding an enterprise research system to manage a robust portfolio of clinical trials across an entire enterprise can be a daunting task. This ebook will help you on your search for the perfect system for your institution. It s important to research what the needs are, what the system offers, and the vendor s level of innovation. It requires time and effort, but the reward is a system that can be used for years to come. To assist in your search, this ebook puts together a 3-step plan, with a series of questions to consider throughout the process.

5 Table of Contents Step 1: Assess Your Institution s Needs How can a system be beneficial? Is now the right time? Who will be using the enterprise research system? What functionality is essential? When is your deadline? How much is involved? Step 2: Evaluate Functionality in Systems Functionality Considerations Protocol, Calendar, & Subject Life Cycle Management Subject Safety Management Study Financial Management & Billing Compliance EDC, Data Management, & Patient Registries Reporting Biospecimen Management Integration Capabilities Technical Requirements & Support Implementation Data Migration & Training Pricing Overall Step 3: Evaluate Vendors The Whole Product Approach Conclusion

6 1Step 1 Assess Your Institution s Needs During Step 1, it will be important to consult with clinical research team members from a variety of areas to get their insight into what s needed from a system. For an enterprise system, a team approach that includes representatives from executive leadership will be very important. It s also suggested to meet with clinical trial office management, end-users, faculty, and your technical team to discuss what s needed. Allow enough time to complete the initial consultation process, so the data can be gathered and provide a comprehensive set of selection criteria. The following pages contain questions that will need to be discussed at your institution. Deploying an electronic clinical trial management system was identified by our faculty as one of the key steps to strengthening the UCSF clinical research enterprise. 1 Susanne Hildebrand-Zanki, Associate Vice Chancellor for Research at the UCSF

7 How can a system be beneficial? Estimate the budget required for the study to be financially feasible to help determine if your institution should participate in the study. Easily manage sponsor invoicing and patient billing reconciliation. Effectively negotiate study budgets by tracking costs. Easily schedule and view all subject visit data in one place across all protocols. Reduce time spent looking for information and documents. Get new staff up and running faster. Eliminate lost time and data due to staff turnover. Simplify compliance processes. Spend fewer hours manually entering data into multiple locations. Gain real-time visibility with reports generated in just a couple of clicks. Experience fewer human errors and spend less time correcting mistakes. 2

8 Is now the right time? There may be a number of reasons you are searching for an enterprise research solution. These can include simplifying billing compliance, interfacing with other systems, meeting regulatory reporting requirements, and much more. Before getting too far along in the process, it s important to make sure that now is the right time. If you re not sure, you may want to ask, How is data currently managed? If the answer contains spreadsheets, manual reports, and multiple systems for visit management, billing, and calendars, then it s time to consider an enterprise research system. Or if your staff isn t utilizing your current system to its fullest extent, is inundated by technical errors, or doesn t have adequate user support, perhaps finding a new system is a worthwhile endeavor. Some common reasons for looking for an enterprise research system include: Reasons for a system Cost Current System Growth Operational Efficiencies 3

9 $ Cost Is your institution using an enterprise research solution, but paying for functionality that isn t being used or that wasn t designed for your institution s operations? If your institution doesn t have a system in place, is it losing money through inefficiencies, duplication of effort, or missed sponsor charges? Current System If your institution uses an enterprise research solution, do you wish it provided different or additional functionality? If your institution doesn t have one, would you find it beneficial to have a central location to house all your data? Growth As your operations grow, do you want a system that can grow with your institution and handle more complex data? Would it be helpful to have a system that supports consistency between studies? Do you need a system that will allow your institution to grow and take on more and more profitable studies? Operational Efficiencies Do you need to improve workflows? Are you looking for ways to save time and money? Do you want to reduce risk related to compliance? Do you want to be able to interface with external systems, such as an eirb or EMR? If you answered yes to any of the above questions, now is the right time to look for a system. Housing all data in one centralized system, can result in reduced costs, increased productivity, and more effectively managed staff time. These are just a few of the many benefits. 4

10 Who will be using the system? There will be many people using the system, and therefore, many people involved in the decision. Though they may not be directly involved in the early stages, their wants and needs must be considered. Who will be the key decision makers? Will all users of the system be able to voice their opinion? Will the decision be made by one? Or, is it a group decision? Though the final verdict may be made by only a chosen few, allowing everyone to provide feedback on the various options can speed the user-adoption process and allow for an easier transition once the system is in place. Who will be using the system? Will it be utilized by all staff members? Or, only select departments? Managers? Coordinators? Financial managers? Are all of the users in agreement on the purchase of a system? It may not be a group consensus to switch to a system. This may be an area to focus on before moving forward. Perhaps refer them to page 2, How can an enterprise research solution be beneficial? Who will be completing the evaluation process? Are the people completing the evaluation of the system the same people who will be making the decision? Are they also the people who will be using the system? Inviting the users to view product demos can ease any uncertainty there may be about the system and gives them the opportunity to ask questions along the way. A great way to get input from across the institution is to build a team, perhaps with one staff member representative from each department. Another option is to conduct targeted demonstrations to specific groups so that end-users see what pertains to their roles and how they will use the system. 5

11 What functionality is essential? The idea of an enterprise research system that can house all your data in one place, manage subjects, track finances, and administer calendars sounds great. But do you need a system with more robust functionality? Additional options include biospecimen management, registries management, built-in functionality and integration capability for simplified compliance, and much, much more. Or would your needs be met with a minimalist system that doesn t require much maintenance? You will want to consider what your needs and goals are for the system, and that could largely depend on which department is driving the search (financials, regulatory, etc.). What is the goal of the enterprise research solution? Is the goal to streamline the workflow of coordinators? To gain greater financial control? To provide management with accurate, quality data when they need it? To reduce the risk associated with compliance requirements? To increase visibility into study activities across the enterprise? Perhaps it s all of these, but having goals in mind can help determine what functionality will be important to you. What functionality is needed? What specifically do you want the enterprise research system to do? Can you prioritize needs vs. wants? Map out a typical protocol life cycle and determine what tools would be particularly beneficial. What functionality is absolutely essential? You should try to establish the needs and wants. What is your growth plan? Where do you see your organization in 2 years? 5 years? The goal of most, if not all, clinical research institutions is to increase operational efficiency. Finding a system that is scalable with your needs and is continually offering new services that complement the system is essential. After all, it will not be beneficial to be doing a search again in 2 years. 6

12 7 When is your deadline? Consider the timeline of the entire selection process from the evaluation and selection of the system through implementation and user adoption. The time from now until the system is fully functioning and used by all applicable staff could be a few months or longer. It all depends on your action plan. By being prepared and having a strategy in place, you can stick to your timeline and soon be using a new system. When is the anticipated purchase? Do you have several months to decide? Or is the need immediate? The number of decision makers involved will likely play a large role in how long the selection process takes to complete. Know what your approval process is ahead of time so that you can plan your timeline accordingly. Are you currently under a contract with another vendor? If so, when is that contract up for renewal? Will there be overlap of the two systems? This will affect the time of deployment as well. When will training be done? Will the vendor s training be done with all staff? Or, will you have product experts at your institution that communicate the training to other users? If so, who will those product experts be? How many training sessions do you anticipate needing? What resources will be available to you after training? When will implementation be complete? How long will it be before all pertinent staff are using the system? Will data need to be migrated from a separate system? Will it be a phased implementation by department or by functionality? Or will all staff be given access immediately? Consider the fact that you will most likely be completing protocols while new ones are being created with the system. With that in mind, how will you manage legacy or on-going studies? How long do you foresee it being before you re completely utilizing the system?

13 How much is involved? Inevitably, the cost of a system must be considered. Each system will have its own pricing model that you will have to look at closely and weigh the benefits. It s all about finding the right system that fits your needs so you aren t carelessly throwing away money. How much is budgeted for the purchase of an enterprise research system? The budget you have allotted for a system will play a large role in the one you choose. When budgeting, be sure to include costs associated with implementation, training and system adoption. Also include the costs associated with maintaining the system on an ongoing basis. Will you have to add FTE s or can you use existing staff? If your budget is on the low end, you may need to go back to the functionality question and decide what s truly a need versus a want. Which departments will contribute to the budget for a system? For example, hospital systems utilizing the eclinical solution may be interested in paying a percentage to decrease billing compliance risks. Keep in mind total cost of ownership. This includes implementation, support, training, upgrades, and more. How much relates to other key points as well: How much involvement from the research staff? This is much like the who question, but rather than asking who the decision makers will be, consider how much actual involvement they ll have. Will you be reporting back to them every step of the way? Will they want to sit in on all the demos? Or, will they be very hands off and just want to know about the top 2 or 3 options you evaluated? Depending on the degree of involvement, this may affect your timeframe. How much of a learning curve will there be? You ll need to consider your users and their experience with technology. If you ve been working with pen and paper up till this point, how long will it take your users to adopt the new system? If they re already familiar with other data management systems, a new system might be an easy transition. Again, 8 this may also affect your timeframe.

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15 2Step 2 Evaluate Functionality in Systems There are many systems on the market that offer many types of functionality. So how do you choose one? Though you might be inclined to start with a simple Google search, you will learn of the best systems through colleagues, industry events, and from speaking with others from institutions with similar research portfolios. Find out what others have used, what their experience has been, and what they might wish was a little different with the system. Make sure you know how current an individual s familiarity with the system has been. Experiences with a system five years ago may not be applicable now, as the industry is always changing and improving. It s best to still conduct your own research and evaluation, while keeping any reviews of it in the back of your mind. Trade shows and conferences are also a great way to learn of options. Not only can you speak to a representative right then and there, but they can often conduct live demos on-site, reducing the time you need to spend researching and scheduling initial meetings. Finding vendors at conferences also shows they are active in the industry, and, likely, on top of the latest trends and developments. 10

16 Functionality Considerations You ve just been bombarded with a series of questions to consider before evaluating your options. Here is where they become helpful. The following pages highlight different types of functionality that may be included in a system. Depending on your institution s goals for a system, the functional features can set a system apart from the rest. 11

17 Protocol, Calendar, & Subject Life Cycle Management Protocol, Calendar, and Subject Life Cycle Management functionality is the foundation of clinical research management. It provides the capability to easily set up protocols and track subject activity throughout the trial. An enterprise research system should provide adequate functionality for simplifying the management of these operations. Protocol Management considerations include: How are protocols managed within the system? Is there an easy way to set up a protocol? Does the system have the ability to share data throughout so that you can minimize data entry? Can regulatory information such as IRB and Scientific reviews be tracked? Calendar Management considerations include: Is there functionality to assist coordinators in tracking subject visits? Does the system track study parameters, such as treatment administration, evaluations and data collection schedules? Is the calendar funtionality tied to financial and billing compliance functionality to help ensure accurate and timely billing? Can the calendar support complex calendars such as open ended treatment schedules, different schedules for treatment arms? Subject Life Cycle Management considerations include: Does the functionality enable you to easily verify subject availability, register subjects, monitor accrual, and track deviations and toxicities? Does the functionality allow you to simply and quickly get a real-time view of all study activity across the clinical research enterprise as well as at affiliated sites? Is there functionality to track subject status, the consenting process and reconsents? Is there functionality to easily track effort related to staff activity? Is there functionality to assist coordinators in tracking subject visits? Can a coordinator easily view visits for their subjects across protocols? Can staff easily track details about a visit, such as additional or missed procedures? 12

18 Subject Safety Management Monitoring the safety of patient activity is crucial while conducting clinical trials. It s important to have centralized access to subject information to ensure safety in a clinical trial. An enterprise research system should have functionality in place that provides instant access to all subject activity. Subject safety management considerations include: Are there automatic notifications based on key regulatory and safety functions, including AE and SAE tracking, Outside Safety Report tracking, and IRB reporting? Are the notifications per protocol as well as across all protocols? Is there functionality to support data safety monitoring? 13

19 Study Financial Management & Billing Compliance Maintaining a grasp on the financial status of studies can be very challenging for clinical research institutions, especially academic medical centers, research hospitals, and cancer centers that manage a large portfolio of trials. A system should provide functionality to easily track activity and generate invoices based upon completed tasks, while preventing billing inaccuracies, loss of revenue, and potential compliance issues. Study Financial Management considerations include: Is there functionality to track costs for all clinical and administrative procedures? Is there a master repository of all charge events to facilitate accurate budgeting? Are there reports available to provide a quick and easy view of the entire protocol, including the budget summary and calendar? Does it provide Versioning of budget and calendars as protocols and charge masters change? Is the financial team made aware of when sponsor payment milestones have been met? Is there automated functionality for invoicing and payment tracking? Billing Compliance considerations include: Does the system include functionality to prevent billing errors, such as billing designations for routine costs and sponsor reimbursement? Does the system provide functionality for documentation of determining if the study is a qualifying clinical trial? Can the system integrate with billing systems or electronic medical record systems to facilitate billing compliance? Is the system flexible enough to react to changes in regulations and protocols? 14

20 EDC, Data Management & Patient Registries Consider the large amounts of data collected while conducting clincial trials, an enterprise research system should provide a centralized system for easily recording and storing data for all trials across the enterprise. This will benefit institutions with organized and complete information gathered from all protocols. Electronic Data Management (EDC) considerations include: Does the system enable granular control over clinical data and monitoring activities across the entire research center? Is there functionality in place to easily export the data as needed? Can ecrfs quickly and easily be created? Data Management considerations include: How is the data currently collected and stored? Does the system provide easy access to all data across all trials? Does the system provide access control and security, limiting access to protocols/subjects to only those who need it? Patient Registries considerations include: Where and how are patient registries currently maintained? Does the functionality allow for easy access to all needed parties? Does functionality assist in meeting HIPAA requirements for protecting patient data? Can registry data be tied in with the rest of the system, eliminating duplicative efforts? Can functionality be linked to external systems, allowing for automatic population of patient data? 15

21 Reporting Reporting is crucial for clinical research institutions. It shows the health of operations with regard to productivity, finances, and time management. Data pumped into reporting can show where weaknesses are for your organization and where improvements can be made. Make sure the system you re considering has adequate reporting tools. Reporting considerations include: How are new reports created? Do you have the ability to customize and save reports? Can any user create reports, or will you need an on-site expert? Does the system include standard reports? Do you have the ability to export data? Can you create reports in a variety of file formats? Are there reports available for regulatory reporting and grant purposes? Will reports be updated by you or the vendor? Are reports updated by the vendor as regulatory requirements change? Reporting functionality to support compliance: Can reports be easily generated for registering clinical trials with ClinicalTrials.gov and NCI s Clinical Trials Reporting Program? Is there functionality to automatically upload the reports to the registries? 16

22 Regulatory & Compliance The regulatory environment is continually evolving in clinical research. It s important that a system helps to address the varying challenges posed. An enterprise research system can help manage such things as IRB reviews and re-consenting, as well as clinical trial disclosure requirements. Check to see what tools are offered in a system. Regulatory considerations include: Can the system be used to record and track IRB reviews? Can the system report on renewal dates for expiring regulatory documents? Are there features to facilitate the re-consent process? Does it help track investigator credentials? Does the system help identify deviations from the protocols? Can a system ease the process of audits? Are notifications and sign-offs available to help with workflow and support best practices? Compliance considerations include: Can the system assist with mandatory reporting requirements? Is there built-in functionality or can a system integrate with other specialized systems? Are notifications and sign-offs available to help with workflow and support best practices? 17

23 Biospecimen Management In the context of large clinical research institutions, the nature of biospecimen management is considerably complex. A system should provide access to inventories and associated data to needed parties while protecting privacy regulations. It should also assist in assuring the quality of each specimen and its associated data. Biospecimen Management considerations include: Does the system provide centralized control over the entire repository at an enterprise level? Does the system provide easy, permission-based access to those who need it? Does the system allow users to capture all data related to a specimen? Is there functionality to simplify the process of reserving, labeling, checking-in, checking-out, and shipping specimens? Does the system support prospective banking as well as correlative studies? Does the system provide reports functionality? Are the reports customizable? 18

24 Integration Capabilities A very large amount of data is being managed by clinical research institutions and associated hospitals in a variety of systems, such as electronic medical records and laboratory systems. Unfortunately, most of the systems are isolated. A system should have a framework in place to integrate with existing systems to eliminate duplicate data entry and protect the institution s investment in technology. A system can also ease the process of reporting data to required databases, such as ClinicalTrials.gov and the National Cancer Institute s Clinical Trials Reporting Program. Integration considerations include: Does your institution have staff dedicated to completing integration of a system with others? Or should a system come with built-in mechanisms to simplify the process? Does the system provide out-of-the-box interfaces for commonly shared systems, such as electronic medical records and electronic Institutional Review Board (eirb) systems? Does the system have functionality for automatically uploading clinical trial data to required databases (such as ClinicalTrials.gov and NCI s Clinical Trials Reporting Program)? 19

25 Technical Requirements & Support Clinical research institutions require a system to support the needs of the enterprise, so it should have the strength to support your users and technical requirements. Find out what the technical specifications are for each system so you aren t caught off guard later on. Once the system is in place, you ll also want to know what the help and support options are from the vendor. Technical considerations include: Are you looking for dedicated hosting? Shared hosting? Cloud computing? Will each user have a unique login? Will you have total ownership of your data? Does the system have role-based access controls for security? Does the system require additional IT support? Will on-site staff be required to maintain the system? Will you have access to the database? Support considerations include: Is support unlimited? If not, how much time is allowed? What are the hours of availability? Is support best reached through or phone? What is the experience of the support staff? Is there online help? Are there webinars and tutorials available? Are there any additional fees for support? Are current customers satisfied with the ongoing support provided? 20

26 Implementation Your implementation goals are a very important consideration when selecting an enterprise research system. The time and cost involved will depend heavily on the scope of the rollout, whether it s specific functionality within a single department or a robust functional footprint across the entire enterprise. Implementation considerations include: Will you be implementing the system within a single department or across the enterprise? What types of functionality will be implemented? If the implementation is enterprise-wide, will functionality differ across departments? If the implementation is enterprise-wide, what will be the strategy for rollout? Will it be phased? What is the expected timeline for your implementation goals? Are resources available to help educate prospective users on the goals and benefits of the system to help promote adoption? Would you have access to other user institutions to ask questions and discuss best practices? 21

27 Data Migration & Training Your institution likely has a lot of data that has already been recorded. The process of transferring and maintaining the integrity of that data needs to be considered. Also, training your staff so they have the know-how to work within the system will be crucial. The right training will ensure your staff is not only knowledgeable about the system, but comfortable using it. Data Migration considerations include: Is data migration available as a service? Does the vendor have experience with data migration from other commercial and/or homegrown systems? Is there an additional cost? Or, will your staff be responsible for all data migration? Is there a quick turn-around? Training considerations include: Is training included in the cost? If not, what is the additional cost? Is training done through , phone, or in person? Are there written reference materials available? What ongoing training resources are available? Are there self-study materials available such as online tutorials and videos? Are there structured programs put in place to ensure users are knowledgeable in all areas of the system? Would you have access to other user institutions to ask questions and discuss best practices? Is training included in the cost? If not, what is the additional cost? Is there a train-the-trainer model so your staff can become experts? 22

28 Pricing Sticker shock can sometimes take your breath away. That s why it s important to make sure you re getting the best product for your needs and for the right price. Consider the total cost of ownership not just the upfront investment. If there are extra fees for support, upgrades, data migration, etc., they will need to be included in the total cost. Also consider the return on the investment. What will you be saving in staff efficiency, having fewer systems to maintain, gaining better insight into study financials, and more? Make sure you fully evaluate the financial commitment of each system. Not all pricing models are the same. Depending on the size of your organization and the number of trials being conducted, the pricing structure can vary. Pricing considerations include: Is there a set-up fee? Is the pricing user-based? Or trial-based? What is the length of the contract? Are additional services/upgrades included? Or are there future costs that need to be evaluated? 23

29 Overall Look at the system as a whole. Other than specific functions, how does the overall system look? Think about how your staff will feel using the enterprise research system. Be sure to include these consideration in your evaluation, as they, too, can influence your decision. Overall considerations include: Is it easy to search and find what you need? Are checklists available? How is the overall usability? Is it user friendly? Is the system customizable? How are customizations upgraded over time? Are you able to upload documents for easy retrieval by other staff members? How has your experience with the vendor been thus far? Do you feel comfortable providing feedback and making suggestions for improvements to the system? Does it meet the needs and priorities of your institution? Is the system configurable? 24

30 3 Step 3 Evaluate the Vendors After reviewing a number of enterprise research systems and completing a thorough evaluation of each, narrow the selection down to those that meet the functionality needs of your institution. But the process isn t finished yet. Now that the list of solutions have been narrowed, it s time to evaluate the vendors. This requires a separate set of questions to be considered, and it s what we refer to as the Whole Product approach. It not only looks at the system, but how the vendors innovate to provide a relevant solution now and into the future. This approach helps you select a system that can be used now and for years down the road. 25

31 The Whole Product Approach For institutions to derive real value from their technology investments there are many considerations that need to be addressed, including the provider. The following provides key questions and a brief discussion of these important considerations. Vendor considerations include: How will the system continue to evolve to keep pace with your institution s changing needs? Does the software vendor have well-defined plans, management controls, and a track record of good performance? Will you become a part of a community of institutions with which you can collaborate? How will innovation from you and other members of the user community get included in newer versions of the software? Does the software provider have proven mechanisms for initial and ongoing training and education to ensure that users have a solid understanding of the capabilities and intended use of the software? Are plans for initial software implementation and subsequent rollout, and mechanisms for ensuring the adoption and active use of the software, in line with your institution s goals and priorities? For more key questions to ask while evaluating vendors, download the Whole Product approach white paper. 26

32 Conclusion Choosing a great enterprise research system that fits your needs and wants can be a challenging task. Institutions must look at what functionality would be most useful to them, and choose a system that is specialized for those needs. Given the right tools and appropriate questions to consider, an institution can make an informed decision about the right solution for them. When a system is a good fit, it will save time and money, ultimately increasing the overall efficiency of clinical research operations. We are about to change the face of how clinical research is conducted at UCSF, and in order to bridge the gaps in front of us, it is important that we conduct this critical task with the right tools and people from the start. Sorena Nadaf M.S. M.MI, Associate Director of Translational Bioinformatics, CIO and Director of the Translational Informatics Program at UCSF 27

33 References UCSF Recovers Significant Revenue, Cuts Operational Costs The Whole Product: An Integrated Approach to Evaluating & Selecting an Enterprise Research System

34 About Forte Research Systems, Inc. Forte Research Systems, Inc. has been developing specialized software for clinical research since The product family includes OnCore Enterprise Research, Allegro CTMS, and Overture EDC. Forte provides complimentary blog articles, ebooks, webinars and more to support continuous learning on industry topics. With a strong belief in community and standards-based development, Forte also facilitates the Onsemble community, the Allegro Community, and Research Resonance Network, a technology-enabled community of sites pursuing data-driven excellence in clinical research operations.

35 Copyright 2013, Forte Research Systems, Inc. Forte Research Systems, Inc. (608) M