How to Increase Site Productivity with a CTMS. Manage financials, meet timelines, increase compliance, and more...

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1 How to Increase Site Productivity with a CTMS Manage financials, meet timelines, increase compliance, and more... By

2 Introduction Clinical trials are essential to the development and safety of new drugs and medical devices. However, they are also expensive and resource intense. It is important that your site is performing at, or above, par to ensure you don t lose precious time and money on a study. While maintaining successful finances and efficiency, your site must also adhere to a host of regulatory policies, maintain compliance, and ensure the conduct of ethical trials. Research continues to grow more complex. Maintaining accurate records while running a successful site becomes even more challenging. With so many demands, a centralized system that can improve the way in which clinical trials are managed comes in handy. This ebook examines how a clinical trial management system (CTMS) can address several concerns and challenges you may face when managing the operations of clinical trials. i

3 Forte Research Systems Software to fit your clinical research needs CTMS solutions for research sites, multi-site trials, SMOs, academic research centers, cancer centers, and CTSAs. Streamlined visit management Efficient financial management Site operational tools Real-time, in-depth reporting Comprehensive software including CTMS, EDC, billing compliance and more for the academic clinical research enterprise. Purpose-built clinical trial management software for research sites, site networks, and SMOs. And more! ii

4 Chapter 1: A Clinical Trial Management System, Defined... 4 Table of Contents Chapter 2: Common Challenges Addressed by a CTMS... 7 Chapter 3: Additional Benefits for the Entire Staff... 20

5 Chapter 1: a clinical trial management system, defined Whether you are currently utilizing a clinical trial management system or are new to the software, this chapter defines what a CTMS is and how specialized systems can be beneficial to you, based on the needs of your research site. 5

6 Chapter 1: A clinical trial management system, defined What is a CTMS? A clinical trial management system (or CTMS) is a software system used to manage all operational data involved with the conduct of clinical trials. The use of a CTMS provides for easy, efficient, and secure organization of this data in a centralized location so that trials can run more smoothly. There are specialized systems available to fit the needs of many types of institutions. There are systems designed to support operations at independent research sites, site networks, and SMOs. Furthermore, there are systems built to support the needs of academic medical centers, CTSAs, research hospitals, and cancer centers. A CTMS can help manage various aspects of a trial, including: Financial Management Visit Management Compliance Business Development Patient Recruitment and more... 6

7 Chapter 1: A clinical trial management system, defined Not all Systems are Created Equal As mentioned on the previous page, there are several systems available on the market from a variety of vendors. To get the maximum return, it is important to identify the right system for your organization. Not all systems are built the same. Take the time to learn where your inefficiencies may be to ensure the system you re looking for addresses those challenges. Are you uncertain if a CTMS can help with your particular challenges? Or, unsure if you re getting the most out of your current system? Read on to see examples of how a CTMS can help increase productivity. 7

8 Chapter 2: Common Challenges Addressed by a CTMS Negotiating Contracts and Maintaining Budgets Managing Timely Payments Effectively Managing Time Spent on Protocols Ensuring Compliance Finding the Report You Want, When You Need It 8

9 Chapter 2: Common Challenges Addressed by a CTMS Challenge: Negotiating Contracts and Maintaining Budgets How often do you receive a budget from a sponsor that meets your financial needs for a study? Often, they re likely to fall short. Negotiating better rates with sponsors is a necessary endeavor to ensure you cover your costs. But, how do you know what your costs are? Have you found yourself entering numbers on spreadsheets or even jotting them down on paper? Not only do these methods leave room for error, it can be difficult to provide consistency across procedures and protocols. There are several components that go into a budget that can make it difficult to calculate properly. Often, sites may accept a trial for the sake of increasing their number of protocols, assuming that the more trials they run, the more profitable they ll be. However, you could be losing money if you aren t tracking your true costs. To achieve financial success, you need to know your costs and what you need from the sponsor prior to accepting the study. 9

10 Chapter 2: Common Challenges Addressed by a CTMS The CTMS Solution: Better Budgets and Receivables Tracking Most clinical trial management systems provide tools to set up a comprehensive budget for each protocol. With a thorough budget, you can ask for the full amount you need from a sponsor to remain profitable. Gain visibility into the financial needs per patient and per procedure Maintain consistency in costs across procedures and protocols Easily calculate overhead, or the cost of doing business Justify costs to the sponsor Once the trial has been accepted, financial management tools in a CTMS allow you to track invoices and payments from sponsors so you can maintain a positive cash flow. You can quickly know what transactions are occurring, and what payments are outstanding. With many sponsors paying quarterly, you can t afford to miss an invoice. In short, using a CTMS for budgeting and financials helps to ensure that you re not leaving money on the table. Our team was impressed with [the CTMS] s ability to function as a onestop-shop for our research management, allowing us to accurately track study payments... Tiffanie Markus, Assistant Director, Vanderbilt Heart and Vascular Institute Download the Case Study for the full story 10

11 Chapter 2: Common Challenges Addressed by a CTMS Challenge: Managing Timely Payments Do you have patients calling to find out where their reimbursement is? Do you have this information readily available? Are the amounts what they were expecting? Issuing payments can be difficult to calculate and maintain if not communicated properly. In a typical setting, coordinators must report when a visit has occurred so that patients can be paid. However, if that is not done immediately after the visit, the risk of it being forgotten or inaccurate increases. At the very least, the payment will probably be delayed. Without a unified system to manage visit and financial data, it can be difficult to find the answers your patients need. Additionally, vendors expect to be paid timely for procedures performed. Missing or delayed payments can negatively impact your relationship with them and jeopardize future opportunities. You may also be responsible for payments to investigators. Keeping track of multiple payments to many different parties can become very challenging and time consuming. 11

12 Chapter 2: Common Challenges Addressed by a CTMS The CTMS Solution: Achieve Prompt Payments A CTMS provides a central location for all study-related information, including visits and financials. This makes it extremely convenient when needing to connect information about the two. As soon as visits have been marked occurred, automation in a CTMS seamlessly communicates this to financials, eliminating the need for verbal or communication of the activity. It becomes virtually impossible for visits to slip between the cracks, ensuring that payments can be made promptly and accurately. Provide patients with fast, accurate reimbursements Easily pay vendors and investigators per visit or per procedure View payment statuses at a glance Retrieve payment history quickly A CTMS can help keep a positive cash flow between your weekly subject reimbursements, monthly vendor payments, and sponsor s incoming payments. Learn how payments are easily managed with the specialized clinical trial management systems from Forte Research Systems. 12

13 Chapter 2: Common Challenges Addressed by a CTMS Challenge: Effectively Managing Time Spent on Protocols Do you know how many hours are spent per study or activity? How much time goes towards patient care versus completing paperwork or administrative tasks? The ability to see into the time requirements of each protocol and recognize where inefficiencies may exist is imperative if looking to improve productivity. The process of compiling workload data can be cumbersome, often getting put aside for tasks that are more directly related to the research at hand. As a result, staff may spend time on study-related tasks that you may not actually be getting reimbursed for from the sponsor. Because the time per task is not known, you may be coming up short when budgeting for a protocol. 13

14 Chapter 2: Common Challenges Addressed by a CTMS The CTMS Solution: Know What Studies are Consuming Your Site s Time Clinical trial management systems are continually evolving, and recently, many have begun to include effort tracking features. Spreadsheets and calculators can now be replaced with a centralized, automated system. Gain insight into where time is being spent Identify any inefficiencies Know where there may be opportunities for improvement Help justify your costs Additionally, knowing how much time is involved with each task plays an important role in negotiating or re-negotiating budgets with sponsors. Ultimately, the tracking of staff effort can increase your site s profitability potential. We are able to see how many hours it takes to start an industry trial. Being able to have the rationale for our startup costs is incredibly valuable in budgeting with sponsors. Kerry Bridges, Administrator, Indiana University Simon Cancer Center Clinical Research Office Download the Case Study for the full story 14

15 Chapter 2: Common Challenges Addressed by a CTMS Challenge: Ensuring Compliance It is critical that clinical research is conducted in compliance with FDA regulations and in accordance with Good Clinical Practice. This includes ensuring that you always have the most current documentation about the protocol, your site, and staff. Tracking this information can cause a lot of headaches if not maintained and properly organized. Do you know exactly where to find all your training documents, certifications, IRB reviews, and informed consents? Are they all in different places? Are they all current? How are new consents tracked for subjects? If your documentation is paper-based, you risk the possibility of loss or damage to vital pieces of your research operations. Many sites that utilize a regulatory binder are now considering the benefits of going electronic with a centralized system. 15

16 Chapter 2: Common Challenges Addressed by a CTMS The CTMS Solution: Know Where Your Documents are at all Times Organization of all essential documentation in a CTMS can help maintain your compliance and efficiency. It eliminates the time to search for the right documents when needed. Everything is stored at your fingertips and can be assessed with just a few clicks. Know where all study-related forms are IRB reviews, informed consents, etc. Manage staff certifications and investigator credentials Alerts let you know when documents are approaching expiration or have already expired 16

17 Chapter 2: Common Challenges Addressed by a CTMS Challenge: Finding the Report you Want, when you Need it Large amounts of data in clinical trials can be hard to consolidate into an easyto-read report. Collecting the necessary information from multiple places can be extremely time consuming, and often, may not be accurate or up-to-date. Without a reporting system, it can be hard to manage timelines and ensure that activities are occurring when they need to and being completed within the desired timeframe. Do you know what your study start-up times are? How long, on average, does it take your site to go through the IRB approval process? What are your typical enrollment timelines? These questions and more can easily be answered in a report generated through a CTMS. 17

18 Chapter 2: Common Challenges Addressed by a CTMS The CTMS Solution: Real-Time, Easy-to-Read Reports One of the best ways to stay in the know is through reports. Simple, easily generated reports in a CTMS provide visibility into the health of your site, which is necessary for managing a successful and productive site. With a CTMS, virtually all entered information can be compiled into a report, eliminating the hours it may take to collect this information from several different sources. Most reports also have the capability to be customized and exported, so they can easily be shared with the team. Reports can cover a wide range of areas such as: Enrollment AEs and SAEs Deviations Subjects and Visits Financials Staff Effort Reports in Forte s clinical trial management systems are quick and easy. Learn more today! 18

19 Chapter 3: Additional Benefits for the Entire Staff In addition to the tools discussed in the previous chapter, there are a variety of ways in which a CTMS can help improve other areas of your site and provide convenience to other staff members. Here are a few more benefits offered by a clinical trial management system. 19

20 Chapter 3: Additional Benefits for the Entire Staff Manage Subject Visits Easier Automated tools in a CTMS provide consistency, encourage compliance, and provide the user access to daily calendars and subject information. Here are some of the types of benefits that may be offered by a CTMS: Automatic calendar assignment with easy re-calculation for simplified scheduling Central repository to maintain protocol, subject, and visit data Easy-to-view daily schedule and tasks Ability to quickly retrieve subject and visit information It takes us no time to enter a subject visit. I m saving at least minutes on every initial subject that I enter. Cheryl Giblin, Administrator, Clinical Study Centers Download the Case Study for the full story 20

21 Chapter 3: Additional Benefits for the Entire Staff Track Patient Recruitment Activities It can be difficult to gain visibility into recruitment activities, keep track of next steps, and determine methods that work and those that need improvement. Some systems offer functionality to help track recruitment initiatives, and much more. Manage recruitment efforts from start to finish. This includes organized call lists, detailed notes on contact history, and next steps for potential participants Identify where there is room for improvement in processes Calculate Return on Investment (ROI) on recruitment efforts, such as advertising 21

22 Chapter 3: Additional Benefits for the Entire Staff Increase Business Development Efforts Most systems provide the ability to perform business development tasks, such as storing sponsor and CRO information. Having a centralized location for this information as well as the ability to track activities, interactions, and documents can greatly improve your chance of obtaining a higher quality and quantity of trials. Additionally, the reports available in a CTMS can provide tangible proof to sponsors and CROs on your performance as a site, and can boost your reputation with them. Sharing charts and graphs that show how well your site performs can put your site in good standing for future trials. Want to learn how tools from Forte Research Systems can help increase your study pipeline? 22

23 Chapter 3: Additional Benefits for the Entire Staff Share this ebook! Standardize processes A centralized system that is used by all staff at a site can promote consistent processes. Standardized fields for entering data promote consistent workflows and can help ensure that data is entered correctly among all staff members. This can strengthen compliance, reduce errors, and make it easier to find the information you need when you need it. Having a common system with standardized fields prevents research staff from having fragmented management systems with multiple process flows. Lindsay Mann, OnCore Enterprise Manager, Indiana Clinical and Translational Sciences Institute (CTSI), Indiana University 23

24 Conclusion Using a CTMS to manage your clinical research operations has many benefits. Not only can it help in areas such as finance and compliance, but it provides the opportunity to streamline workflows by saving your staff time and effort on tasks that may traditionally take them several hours. This can result in higher productivity and more time spent conducting the research at your site. To learn more about the specialized systems provided by Forte Research Systems, please visit Have questions? We would love to hear from you! Forte offers additional educational resources to help you pursue clinical research excellence. View our additional resources today! 24

25 About Forte Research Systems, Inc. We have been providing systems that support excellence in clinical research operations for over a decade. In this time, it has been our good fortune to work collaboratively with our customers as we developed new products and enhanced product functionality to meet the challenges that they face every day. We strive to be the recognized thought leader and preferred provider of innovative solutions that help improve operational efficiency, patient safety, regulatory compliance, and financial viability. The OnCore eclinical solution is specialized to meet the needs of academic medical centers, CTSAs, research hospitals, and cancer centers. In addition to patient registries, biospecimen management, and billing compliance, OnCore offers CTMS, EDC, and data management for the clinical research enterprise managing a robust portfolio of clinical trials. The Allegro CTMS solutions are purpose-built clinical trial management systems for research sites, site networks, and SMOs. The systems are easyto-use, cloud-based and intuitively designed. Investigator sites and research groups rely on the single-site edition to support streamlined clinical research operations while the multi-site edition is used by investigator site networks and SMOs to support communication and workflows. 25

26 Referenced Case Studies Heart Institute Improves Budgeting and Payment Tracking Indiana University Effectively Manages Staff Workloads; Streamlines Budget Negotiation Subject Visit Management with Allegro CTMS 26

27 Copyright 2013 Forte Research Systems, Inc. Forte Research Systems 1200 John Q. Hammons Drive, Suite 300 Madison, WI (608)

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