Selecting a CTMS. A How-To Guide to Selecting the Right Clinical Trial Management System. By Forte Research Systems, Inc.

Selecting a CTMS A How-To Guide to Selecting the Right Clinical Trial Management System By Forte Research Systems, Inc.

I Introduction You ve been tasked with finding a CTMS. Now What? Finding a clinical trial management system (CTMS) for your entire site is a big responsibility and can be a daunting task especially when you don t know where to start. This ebook will help you on your search for the perfect CTMS for you and your team. In the end, they ll be thanking you for finding a great system that s easy to use and saves them time. In fact, they ll begin to wonder how they ever got by without it! But, before you rush into a CTMS, take the time to research what you need, what the system offers, and how it will fit with your site and staff. It may seem like a lot of work now, but you ll be grateful you did your homework when you find a system you can use for years to come. And, it will save you the time of having to look for a new CTMS again in a few years. So, to help you easily map out your time and find the ideal CTMS, this book puts together a game plan, with a series of steps and questions to consider throughout the process. In the following pages you ll learn: CTMS Basics: What is it, and how can it benefit me? What do I need to consider before conducting CTMS evaluations? How do I find CTMS vendors? How do I use a scorecard to evaluate a CTMS? Implementation Basics: You ve found a CTMS now what?

Table of Contents Chapter 1: What exactly is a CTMS? Are there any specialized systems for me? Is now the right time? How can a CTMS benefit me? Chapter 2: How do I select a CTMS? Who? What? When? How much? Chapter 3: Selecting Vendors Chapter 4: Scorecards Protocols, Subject Database, & Visit Management Financial Management & Payments Reporting Business Development & Study Feasibility Regulatory & Compliance Technical Requirements & Help and Support Data Migration & Onboarding and Training Pricing Overall Chapter 5: And the winner is Chapter 6: CTMS Implementation Conclusion 1 2 3 5 6 7 8 9 10 11 12 14 15 16 17 18 19 20 21 22 23 24 25

1Chapter 1 What exactly is a CTMS? In an industry comprised of countless acronyms, this is undoubtedly one that you ve heard multiple times. By definition, a Clinical Trial Management System, or CTMS, is a software system used to manage operational data involved with the administration of clinical trials. The use of a CTMS provides for easy, efficient organization of data in a centralized place so that trials can run more smoothly. Depending on the CTMS, there are several components that it may encompass. At the very minimum, it should address project management, financial management, and patient management. Some systems go on to include such things as performance metrics and supplies management. Regardless of the system you choose, you should be sure that it gives you a positive return on investment (ROI). Did you know...? More than 80 percent of companies that outsource * a CTMS achieve a positive ROI. 1 1 * As opposed to a home-grown management system, an outsourced CTMS refers to one that s been adopted from an outside vendor.

Are there any specialized systems for me? Yes! And it would benefit you to find one specialized for the complexity of your research. There are many CTMS 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 three very different systems, each targeted toward a specific market. The OnCore system is designed to meet the needs of large academic medical centers, research hospitals, and cancer centers managing robust portfolios of clinical trials, often including many investigator initiated trials. Allegro CTMS@Site is a cloud-based system that supports the clinical trial process and operational data for investigator sites and research groups. Allegro CTMS@Network is a cloud-based system with all the functionality of Allegro CTMS@Site, plus additional features to meet the needs of site and trial management organizations and investigator site networks. Virtually every organization involved with clinical trials stands to benefit from a CTMS. Finding a specialized system that is appropriate to the needs of your organization is what this book is all about. 2

Is now the right time? There may be a number of reasons you re looking for a CTMS (other than management asking you to). Before you get too far along in the process, make sure that now is the right time. If you re not sure, you may want to ask yourself, How is my data currently managed? If your answer contains spreadsheets, manual reports, and multiple systems for visit management, billing, and calendars, then it s time to consider a CTMS. Or, if your staff isn t utilizing your current CTMS system to it s 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 a CTMS are: Cost Current System Growth Operational Efficiencies 3

Cost Are you using a CTMS, but paying for functionality you aren t using or that wasn t designed for you? If you don t have a CTMS in place, are you losing money through inefficiencies and duplication of effort? Current System If you use a CTMS, do you wish it provided different or additional functionality? If you don 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 you and handle more complex data? Wouldn t it be helpful to have a system that supports consistency between studies? Operational Efficiencies Do you need to improve workflows? Are you looking for ways to save time and money? Is now the right time? If you answered yes to any of the above questions, congratulations! You should be looking for a CTMS. Luckily, you re in the right place. As your volume of data increases, so does your need for a proficient CTMS that can handle the complexity of your studies. By housing all your data in one centralized system, you can reduce costs, increase productivity, and manage staff time more effectively. These are just a few of the many benefits. Once you begin using a CTMS, you will certainly uncover more! Read on and learn exactly how to find a system that can solve all these problems. 4

How can a CTMS benefit me? Estimate the cost of conducting a study before you even begin to decide whether it makes financial sense to accept the protocol. Search for prospective study subjects and minimize patient recruitment costs with patient registry searches. Easily monitor incoming and outgoing payments with financial management tools. Easily schedule and view all subject visit data in one place across all protocols. Stay current and eliminate forgotten or overlooked tasks with staff and visit calendars. Reduce time spent looking for information and documents. Get new staff up and running faster. Eliminate lost time and data due to staff turnover. 5 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.

2Chapter 2 How do I select a CTMS? Selecting a CTMS is really a multi-step process. Before you ever begin the evaluation process, there are several questions you need to ask yourself. In most cases, you will need to ask other site staff and managers, as well, to get their input. Allow yourself time to complete this initial interview process so that you can easily gather data for selection criteria. A full PDF of these questions can be downloaded at http://pages.forteresearch.com/interviewandscorecard. 2 Most likely you ve gotten to this point because someone in your organization decided they needed a better way of doing things. Perhaps they ve already determined that now is the right time. So the first question, Why? can easily be answered. If not, then you probably wouldn t be reading this book. Why do you want a CTMS? Because it will make your trial management easier and more productive! But what are the other questions you should be asking? Read on to find out WHY WHO WHAT WHEN 6 HOW MUCH

Who will be using the CTMS? You may have been the one given the task of finding a CTMS, but you re not alone. There will be many other people using the system, and therefore, many other people involved in your decision. Though they may not be directly involved in the early stages, their wants and needs must be considered. WHO 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 CTMS 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 CTMS? It may not be a group consensus to switch to a CTMS. In fact, some people may not even know you re looking! This may be an area to focus on before moving forward. Perhaps refer them to page 5, How can a CTMS benefit me? Who will be completing the evaluation process? Are the people completing the CTMS evaluation 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 site is to build a team, perhaps with one staff member representative from each department. 7

What functionality is essential? The idea of a CTMS 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 all the bells and whistles? 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. WHAT What is the goal of the CTMS? Is the goal to make it easier for the coordinators? To better manage finances? To provide management with accurate, quality data when they need it? To increase patient compliance? 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 CTMS to do? Can you prioritize needs vs. wants? Map out a typical protocol life cycle and determine what tools would be particularly beneficial. What can t you live without? Keep this in mind. You should try to establish the needs and wants in order to help create a scorecard, as will be discussed later in this book. What is your growth plan? Where do you see your organization in 2 years? 5 years? The goal of most, if not all, organizations is to increase profitability. And, one way to do that is to increase the number of studies and the size of studies they take on. Finding a CTMS that is scalable with your needs and is continually offering new services that complement the system is essential. After all, you don t want to be doing a CTMS search again in 2 years. 8

When is your deadline? Consider the timeline of the entire CTMS process from the evaluation and selection of the CTMS through implementation and user adoption. The time from now until your CTMS is fully functioning and used by all applicable staff could be as little as a few weeks, or take several months. It all depends on your action plan (see Implementation at the end of this book). By being prepared and having a strategy in place, you can stick to your timeline and soon be using your new CTMS. WHEN When is the anticipated purchase? Do you have several weeks 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? These 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 site 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 it be a phased implementation by department? 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 CTMS. With that in mind, will you implement one protocol or all? How long do you foresee it being before you re completely utilizing the CTMS? 9

How much is involved? HOW MUCH Inevitably, the cost of a CTMS must be considered. Keep in mind that higher price does not necessarily equal a better system, and conversely, lower price doesn t always mean an inferior system. 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 a CTMS? The most obvious of questions. The budget you have allotted for a CTMS will play a large role in the CTMS you choose. When budgeting, be sure to include any add-on costs such as trainings and upgrades that may not be included in the initial investment. 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. Also, a more expensive CTMS with every feature under the sun may seem great but if you re not going to use half of it, it may not be the best bang for the buck. 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 time frame. How much of a learning curve will there be? You ll need to consider your users and their technology experience. 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 CTMS might be an easy transition. Again, this may also affect your time frame. 10

3Chapter 3 Selecting Vendors There are many CTMS vendors on the market. So, how do you choose? In the remainder of the book, we provide you with scorecard evaluation criteria to help evaluate all your options. To get a thorough assessment of the available systems, it is recommended you evaluate at least three vendors, depending on your time constraints. Let s start with how to find these vendors. Though you might be inclined to start with a simple Google search, you will learn of the best vendors through colleagues and industry events. 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 the CTMS 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 CTMS vendors. Not only do they provide you the opportunity to 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 that they are active in the industry, and, likely, on top of the latest trends and developments. 11

4Chapter 4 Scorecards - Scoring and Weighting You ve just been bombarded with a series of questions to consider before evaluating your CTMS options. Here is where they become helpful. The following pages highlight different aspects of a CTMS scorecard. They can be used to thoroughly differentiate one CTMS from another. Much like the parts of the human body work together harmoniously, so should the CTMS. A scorecard will help you examine various components of a CTMS, such as the technical requirements, capabilities of different functionalities, and price. 12

How does each CTMS measure up? Based on your pre-determined needs and wants, weigh each criterion with a 1-to-5 rating 5 being an absolute must have, and 1 being a nice to have, but not a necessity. If an evaluation criterion does not apply, then it can be left blank. These ratings should remain the same for all evaluations that you do. Then, after learning about each CTMS, complete the score from each section with a 1-to-5 rating 5 being great functionality and usability and 1 being sub-par or complete lack of functionality within the system. It is important that the same person or group of people complete each vendor evaluation so there s consistency in the scoring. Once all sections have been completed, multiply the weighted score with the evaluation score to get your total points on each criterion. Add all the points and the CTMS with the highest score will be your optimal system, based on your organization s needs and wants. The following pages break down and explain the various sections of the scorecard. A full PDF that can be used for your own evaluations can be downloaded from http://pages.forteresearch.com/interviewandscorecard. 3 13

Protocols, Subject Database, & Visit Management The clinical trial process would not be successful without the participation and commitment of patients. As the backbone of your trials, you need a system that can track all the crucial data related to various protocols, subject databases, and visits. Protocol considerations include: How are protocols managed within the system? Is there a protocol calendar? If so, is it user friendly? Can you manage other study aspects such as IRB reviews, drug accountability, and supplies? Subject database considerations include: Does the CTMS have a patient registry search? Can you record medical conditions? Can you record various therapies? Visit management considerations include: Can you easily populate the subject visit calendar? Can you recalculate subject visit dates if needed? Does the calendar sync with Outlook or other calendars? Is there a re-consent workflow? Does it include record keeping and management of AEs and SAEs? Can the system track protocol deviations? Do the protocol activities synchronize with financials? 14

Financial Management & Payments Long gone are the days of counting on your fingers and toes! Manually calculating finances and payments is not only tedious, but often has more opportunities for error. Your CTMS should do the work for you! Having a CTMS is essential for the financial health of your site. You will reduce billing errors, invoice promptly and accurately, and be able to manage all incoming and outgoing payments. Learn what features and functionality are available in each system. Financial management considerations include: Are you able to add, edit, and amend visit payments? Can you generate and print invoices? Does the system do revenue forecasting? Are you able to view invoice histories? Do financials synchronize with the protocol calendar? Payments considerations include: Does it record and manage vendor payments? Patient reimbursement payments? Investigator payments? Can you electronically issue patient reimbursements? 15

Reporting Reporting is the heart of any business, including that of clinical research sites. It shows the health of your site, with regard to productivity, finances, and time management. Data pumped into reporting can show where weaknesses are, and where improvements can be made. Make sure the system you re considering has adequate reporting tools to manage your site s operations. 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 and view dashboards for various reports? 16

Business Development & Study Feasibility With business development initiatives, you want to put your best foot forward. Consider what tools a CTMS has available to help make business development easier. Learning the viability of protocols before startup can also aid in growing a strong business. If the CTMS offers a study feasibility analysis, you should be able to look at trials in process and determine if you have an adequate number of patients in the database. From that data, you should have the financial justification for acquiring a new trial. Business development considerations include: Do you have the ability to track and manage sponsor opportunities? Can you track and manage recruitment initiatives? Does the system easily manage contacts and your communications with them? Are documents easily stored for future reference? Study feasibility considerations include: Does it calculate protocol start-up charges? Can you calculate per subject expenses? Does it easily format loaded charges into a budget? 17

Regulatory & Compliance When it comes to regulatory and compliance, who s looking out for you? A CTMS can help manage such things as IRB reviews and re-consenting. Check to see what tools different vendors offer in their system. Regulatory and compliance considerations include: Can the system record IRB reviews? Can the system report on renewal dates for expiring regulatory documents? Are re-consenting forms easily accessible? Does it help track investigator credentials? Does the system help identify deviations from the protocols? 18

Technical Requirements & Help and Support You need a strong, powerful CTMS. Will it have the muscle 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? If cloud computing, is it a secure site? 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? Help and support considerations include: Is support unlimited? If not, how much time is allowed? What are the hours of availability? Is support best reached through email or phone? What is the experience of the support staff? Is there on-line help? Are there webinars and tutorials available? Are there any additional fees for support? 19

Data Migration & On-boarding and Training Unless you re just starting up, you likely have a lot of data you ve already been recording. The process of transferring and maintaining the integrity of that data needs to be considered. Also, training your staff so they have the brain-power and 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? Is there an additional cost? Or, will your staff be responsible for all data migration? Is there a quick turn around? On-boarding and Training considerations include: Is training included in the cost? If not, what is the additional cost? Is training done through email, 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? 20

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 training, data migration, upgrades, etc., they will need to be included in the total cost. 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. With knowledge of all costs involved from a CTMS, you can breathe easily! 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? 21

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 CTMS. Be sure to include these 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? Will it provide an adequate audit trail? 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? 22

5Chapter 5 And the winner is... After reviewing a number of CTMS vendors and completing a thorough evaluation of each, look at the scores on each scorecard. Having all the information to compare side by side will show similarities and differences, as well as point to the strengths and weaknesses of each system. The CTMS with the highest score will be the best CTMS to meet your needs and you can share the good news with your team! But wait, it doesn t stop here... 23

6Chapter 6 CTMS Implementation Congratulations! You ve found a CTMS! You ve sat through numerous demos, shared your findings with your peers, presented the results at various meetings, and finally, you ve made a commitment to a CTMS. Now what? It s time to implement the system and educate the rest of your staff on its usability. A great CTMS is only efficient when all your users are on board. By creating roles and responsibilities and setting timelines for this process, you can be on your way to enjoying your new system in no time! Consider the following questions as you begin your CTMS implementation. Some of these may have been answered already in your information gathering in the first half of this book. Who will make setup and data-import decisions? Will you roll out to users in phases or will all users adopt the system at once? Who should participate in trainings? How will the CTMS be used in daily operations? What is the time frame to be fully deployed? 24

Conclusion Choosing a great CTMS that fits your needs and wants can be a challenging task. Sites 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, a site can make an informed decision about the right CTMS for them. When a CTMS is a good fit, it will save time and money, ultimately increasing business and profitability. Great work choosing your CTMS. Enjoy the new system! 25

References 1 Nucleus Research, www.nucleusresearch.com CTMS User Adoption: Strategies for Success, by Angela Pfotenhauer, Senior Product and Training Specialist, Forte Research Systems http://www.forteresearch.com/news/2012/04/ctms-user-adoption-strategies-for-success/ 2 Interview Download http://pages.forteresearch.com/interviewandscorecard 3 Scorecard Download http://pages.forteresearch.com/interviewandscorecard

About Forte Research Systems, Inc. Founded in 2000 and headquartered in Madison, Wisconsin, Forte Research Systems, Inc. develops and markets clinical and translational research management software. OnCore, the company s flagship system, is the most widely adopted, enterprise-class clinical research platform among academic medical centers, research hospitals, and cancer centers in the United States. OnCore is a clinical research management system designed for the clinical research enterprise managing a robust portfolio of clinical trials, including investigator initiated trials. Forte s Allegro Research on Demand products are easy-to-use, intuitively designed systems that support clinical research operations excellence. Allegro CTMS@Site is designed for investigator sites engaged in industry-sponsored clinical trials. Allegro CTMS@Network is built for site management organizations and investigator site networks. By adopting a highly collaborative product development process, Forte Research Systems gathers, distills and fine-tunes the best ideas from world-class research institutions to deliver solutions addressing key operational challenges.