Patient Recruitment: Tools for Success. The CTMS Solution

Patient Recruitment: Tools for Success The CTMS Solution By

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 About Forte Forte has 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, financial viability, and regulatory compliance. Real-time, in-depth reporting And more! 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. i

Current Challenges Without a CTMS Share this ebook! Without a centralized system to manage your recruitment efforts, you may be missing out on opportunities to meet your enrollment goals. Patient recruitment is often a long and tedious process, consuming valuable time and money. Therefore, it is important to recognize areas for improvement that would allow you to spend more time on the actual research and less effort trying to locate, screen, and enroll your subjects. Traditional paper-based recruitment poses several challenges: It can be difficult to maintain by more than one person There may be a need for repetitive data entry of qualified subjects into another system Measuring return on investment (ROI) can be taxing Pulling reports on recruitment-specific activities is often challenging To optimize enrollment, it is necessary to track all potential subjects and communications with them during the recruitment process. When conducting multiple recruitment efforts across several studies, this can become extremely difficult. Using a clinical trial management system can positively affect your recruitment outcomes. 3

Why a CTMS is Beneficial to Recruitment Share this ebook! Sponsors and CROs are becoming increasingly choosy on the sites they initiate on their studies; they want to work with sites that are high-performing, enroll efficiently, and are organized with a solid plan of action. Jennifer Whitlock, Vice President, Clinical Site Services Sponsors want to know that you ll be able to meet enrollment targets for their study. The market for clinical studies is becoming more competitive, and sites position themselves well when they are able to demonstrate their ability to conduct a well-run trial. Showing sponsors proof of your past performance in areas such as recruitment can prove invaluable when they may be choosing between your site and another. With a CTMS, you can provide the metrics that they seek. Additionally, by using a CTMS as part of your recruitment process, you will more accurately be able to track ROI and learn what channels are the most effective. This allows you to make adjustments as necessary while the study is open to enrollment, as well as plan better for future studies that may have similar requirements. 4

Share this ebook! What is a CTMS? A Clinical Trial Management System (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. This guide will dissect the components that may be available within a CTMS to assist in patient recruitment, specifically: Specific functionality that sites may find beneficial can include: Subject Visit Management Financial Management Patient Recruitment Business Development There are specialized systems available to support the operational needs of many types of institutions from independent research sites and site networks, to the more complex needs of academic medical centers, research hospitals, and cancer centers. Patient Databases Pre-Screen Questionnaires Recruitment Tracking Website Application Reporting 5

Share this ebook! Patient Databases The best and least expensive patient comes from a site s own database. Therefore, the patient database in a CTMS can be extremely cost effective when it comes to locating the ideal patient population. Within a CTMS, you can quickly and easily filter for subjects, based on any number of criteria. In many cases, this criteria can be customized by the site, so you know exactly what patient information is searchable. Examples include age, gender, medical condition, or current medications. Benefits at a glance Leverage your own database to increase enrollment Minimize time and money spent on other recruitment channels Easily filter subjects based on pre-defined criteria With a list of pre-qualified contacts from your database, you have a great place to begin your recruitment efforts. 6

Pre-Screen Questionnaires Share this ebook! It is advantageous for sites to conduct an initial pre-screen of potential subjects prior to them ever being seen. This helps to identify early on which subjects would best qualify for the trial and eliminate those who would not. Some systems provide the means to set up prescreen questions within the CTMS, allowing you to easily update and track answers, as well as reference them in the future, if needed. Additionally, having these answers at your fingertips can provide insight into trends that may be forming among the pre-screened population. For example, if enrollment is low, you may need to re-examine the questions being asked and make a few adjustments. Benefits at a glance Easily retrieve subject information in one place Eliminate paper clutter and having to dig through binders of questionnaires Quickly update answers, if necessary Review ineligible forms for trends Take your Recruitment to the next level! Contact us to learn how. 7

Share this ebook! Recruitment Tracking Tracking your recruitment activities is very important for the overall efficiency of the site, measuring the ROI, and sharing results with sponsors. Some systems have the capability to track all activities associated with recruitment from the pre-screen questionnaire, through to enrollment, and beyond. This can include the type of recruitment channel used, costs associated with it, the number of potential subjects responded and enrolled, as well as all communications with the subjects. With all information in one place, measuring results is easy. It also simplifies the process of enrolling a patient to a study. Since pre-enrollment activities are completed in the same system as where the protocol and visit tracking lives, it is a seamless transition. Benefits at a glance Easily track your return on investment (ROI) Learn what channels work best for each study or patient population Identify where adjustments can be made for maximum return Maintain all communication with subjects from start to finish Quickly and easily enroll patients directly to the study with just a couple clicks, eliminating any duplicate data entry 8

Share this ebook! Website Application Some clinical trial management systems have the capability to communicate study related information to your customer-facing website. This can be very valuable to patients searching for available studies for their condition, and thus, eases the recruitment process since they are actively coming to you versus you trying to find them. It also eliminates the need to manually update your website every time a new trial opens to enrollment or another one closes. With a well-designed website application, the system will pull the qualifying information for the study into a clean, easy-to-read format that enables the patient to find the right study for them directly from your website. Benefits at a Glance Eliminate duplicate entry of study information to your website Easily recruit subjects via your patient-facing website Get the right patients for the right trials without spending extra money on recruitment efforts 9

Share this ebook! Reporting In order to maximize your time and effort from recruitment activities, you must understand what s working well and what needs improvement. Reporting features in a CTMS provide full visibility into recruitment efforts occurring at your site. Pulling a simple report can provide statistics such as the number of patients contacted, screened, or enrolled on a study. Additionally, if recruitment expenses have been entered, it can automatically calculate ROI. Types of Reports in a CTMS Target enrollment vs. actual enrollment Revenue forecast by enrollment Screen failures per protocol Subject registration status Referral details and more! The ability to view these reports in real-time gives you a view into the current state of your recruitment efforts. By understanding what works best for your site, you can easily make better informed decisions about future studies and recruitment techniques. 10

A Streamlined, Unified Solution Share this ebook! In a competitive environment, using a CTMS can help you achieve your desired enrollment goals and position yourself as a well-performing site. By doing so, you increase the possibility of obtaining of a higher quality and quantity of studies. A CTMS also allows you to streamline your recruitment workflows and manage your advertising dollars effectively. If not currently using a CTMS, now may be the time to consider all of the benefits it can provide. Sites already utilizing a CTMS may also find it useful to evaluate their current system to ensure it s capabilities are adequately meeting their needs. All systems vary in features, and recruitment tracking is an important component that should not be overlooked. By tracking your efforts in a CTMS system, Sponsors and CROs are much more willing to provide additional advertising dollars if they see you ve done due diligence with the funds. Annie Garvey, Director of Patient Outreach, PatientWise 11

Share this ebook! CTMS Solutions There are several CTMS solutions available to the clinical research community. Finding the right system that suits your needs is important to the overall success and adoption of the system at your site. To learn about features that can aid your recruitment efforts in the clinical trial management systems offered by Forte Research Systems, click on the thumbnails below. Learn how a system can track recruitment activities and communications. Learn how a system can support multiple registries across the enterprise. for research sites, site networks, and SMOs for academic medical centers, CTSAs, and cancer centers 12