Proving the Return on Investment for eRegulatory
A study of how leading research centers, CROs and sponsors cover the cost of eRegulatory tools... and then some.
Precision medicine and immunotherapy clinical trials transform research while spiking demand at the research centers best equipped to conduct them efficiently and compliantly. In parallel to this increasing demand, study volume and protocol complexity are on the rise. These centers need to scale their operations and accelerate trials while remaining compliant. As a solution to these challenges, tools are emerging for the automation of study tasks, including Florence eBinders™, but how can a site manager prove that they provide a positive return on investment? This whitepaper examines six economic drivers paying back the cost of an eRegulatory and eSource platform (eBinders) so that centers can make an informed decision as they scale to advance cures. The findings show that oncology centers can capture nearly $20,000 of benefit per study. The clinical trial landscape is changing. Research, especially in oncology, is turning toward precision medicine and immunotherapies that more precisely target disease. While patient outcomes are improving (Five-year cancer survival rates increased from 49% in the 1970s to 68% in the 2010s (AACI 2017)), precision medicine harbors three unexpected consequences for research sites: 1. Study volume increases as disease areas become sub- segmented and paired with more precise therapies 2. Protocol complexity increases as therapies themselves become more complex 3. Enrollment requires greater precision resulting in fewer enrolled patients per site and requiring reduced overhead per patient Indeed, according to EP Vantage Analytics, in the past five years immuno-oncology protocols have become more complex and study volume has tripled (EP Vantage Analytics, 2017).
Study Abstract
Study Introduction
The ROI of an eRegulatory Platform
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As study volume grows, here is the core issue – an increase in study volume and protocol complexity means a direct increase in task volume, but site resources are not increasing along the same rate. In fact, they’re not increasing at all (EP Vantage Analytics, 2017).
The Problem
Consequently, sites are being tasked with triple the work with the same amount resources and staff and budget.
The best research centers break above the workload logjam with technology: eRegulatory and eSource tools automate manual processes, reduce duplicate work, and standardize tasks in order to build predictability and increase compliance. Adopting these tools gives research teams the power to complete tasks more quickly and automate low level work so that they have more time to enroll and care for their patients. While the above benefits seem intuitive, the seasoned center manager should map out how such a tool helps in economic terms and build a return on investment (ROI) justification. We’ll explore exactly that here in a six part framework.
The Solution
The ROI of an eRegulatory Platform
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ROI Approaches and Assumptions How can the ROI of eRegulatory and eSource tools be calculated? Using input from NCI centers, we detail how tools like Florence eBinders return 2 to 7x their cost each year via six economic benefits totaling nearly $20,000 in potential positive economic benefit per study:
Per Study Benefit
Per Study Impact
Revenue from the capacity to run more studies $12,000
Cost reduction from streamlined workflows
$3,600
Revenue from startup bonuses
$2,000
Risk reduction through compliance assurance $2,000
Revenue from document management
$1,000
Cost reduction during remote monitoring
$400
The next sections will detail how the Florence team got to these six conclusions. Throughout we’ll use the following simplistic assumptions for cancer research centers. Other disease areas will be directionally similar, contact your Florence representative (info@florencehc.com) to help adjust these figures for industry-sponsored research outside of cancer. Readers can extrapolate from these assumptions to apply the six frameworks to their research center: • Center activity: 50 active studies per year • Average study annual revenue: $100,000 • Median fully-loaded annual cost of study personnel $75,000
20K Financial Impact per study
The ROI of an eRegulatory Platform
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Revenue from the Capacity to run more Studies
Although study demand is on the rise, many centers find it challenging to scale beyond current study volume. Manual processes such as printing/scanning/filing, date tracking, project milestone management, and other tasks eat into bandwidth. How much can automation through software help? At Florence, we timed trained personnel across tasks like document annotation, signatures and filing (Florence Healthcare Analysis, 2015). Electronic tools were found to speed these tasks by 40%. We estimate that these time savings affect about 30% overall study tasks, allowing your research team to take on (30% * 40%) = 12% more studies.
12% More Studies
with same resources
Net: A research center managing 50 studies can find capacity through software automation to take on six more with the same staff. At $100,000 per study, this drives over a half-million dollars in additional revenue.
The ROI of an eRegulatory Platform
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Cost Reduction from Streamlined Workflows
Workflows are the heart of clinical trial document management. Review and signature processes for 1572s, financial disclosure, protocols, and serious adverse events absorb research staff time as they manage compliance considerations like routing, form completion, annotation and signatures. Secondary tasks in these workflows create additional waste. Repeat filing of similar documents from study to study, scanning and printing documents between digital and physical states, maintaining paper logs and to-do lists, and printing and filing emails for correspondence binders all steal precious hours from coordinator to principal investigator. Pre-programed eBinder workflows can eliminate the administrative burden on investigators, minimize the likelihood of misplaced documents, drive consistency, and provide a new level of process oversight to clinical trial management. Documentation processes move faster and require less work, allowing teams to go faster while focusing on more important tasks.
$3,600 per study per year
Net: Electronic document routing editing and signatures removes an estimated person-day per month, per study— $300 per day each month equals approximately $3,600 a year per study.
The ROI of an eRegulatory Platform
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Revenue from Startup Bonuses
Sponsors are keen to get drugs to market as early in their patent-window as possible and days of study acceleration can mean millions in additional revenue for a given therapy. As an incentive to speed studies, sponsors are offering sites startup bonuses – payments received for hitting specified startup metrics such as site initiation and time to first patient.
$2,000 average per study bonus
Sponsors are offering startup bonuses exceeding $10,000 per protocol per site (Florence Healthcare Analysis, 2017).
eBinder platforms can help sites meet sponsors’ needs by reducing task time and accelerating the overall startup phase. Centers can capture more startup bonuses as a result.
Net: We estimate one in five studies can reliably deliver this bonus, so on average startup bonuses yield $2,000 per industry- sponsored oncology study.
The ROI of an eRegulatory Platform
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Risk Reduction through Compliance Assurance
Disorganized paper regulatory and source exposes sites to compliance risk. Study binders can contain mis-tracked versions, particularly as documents are switched between paper and digital formats during sponsor communications. Moreover, paper management approaches allow missing and expired documents to go undetected until audit. Implementing an eBinder system reduces or eliminates those risks and drives the following compliance benefits: • Alerts provide compliance risk reduction between monitoring visits • Version control ensures the right version of documents are in the study team’s hands • Audit trails ensure the right processes were followed Programmable workflows deliver consistent process across teams and studies
$2,000 average per study
Net: A negative compliance finding puts future sponsor opportunities at risk. A research center managing 50 studies may find their next $100,000 study to be in jeopardy. Spread across other studies this equates to $2,000 per study.
The ROI of an eRegulatory Platform
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Revenue from Document Management and Retention Fees
A portion of the cost of eBinder tools can be recuperated via cost pass-through. Specifically, the following line items can in total drive on average $1,000 in additional revenue per contract.
$1,000 average per study
• Startup • Document management • Monitoring prep
• Document storage • Regulatory upkeep • Query response
Net: we estimate an additional $1,000 per industry in document management and retention fees.
Cost Reduction During Remote Monitoring
Remote monitoring is a goal for many sponsors, but the practice shifts work to sites. Requests for scans and emails of paper documents can quickly become overwhelming. In 2016, MAGI and Florence teamed to analyze the workload impact of remote monitoring. The study found that during the course of the average trial, approximately 2.5 visits were conducted remotely, and the prep time for each visit totaled 225 minutes—more than 2x the prep time required for an on-site monitoring visit. Remote monitoring visit prep time can be reduced to zero if access to digital regulatory and source is permitted through an eBinder tool. This recoups an estimated 9 hours of research teamwork per study, per year. Net: Nine hours of work per study per year, or about $400, can be saved by providing remote monitor access via an eBinder system.
$400 average per study per year
The ROI of an eRegulatory Platform
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Additional Quantitative & Qualitative Return for eRegulatory Enabled Research Sites Let’s be clear here. While the above is impactful – and necessary – for a proper evaluation of your future eRegulatory investment, many benefits don’t fit in a traditional ROI model. These qualitative measures of value are expressed in ways unique to each research site, but equally important, especially in terms of reviewing your investment over time. For example, a research site may ask questions like, how will this technology effect the culture of research at my organization? Will this technology expand our opportunities with experienced scientists and Principal Investigators? Will our research team benefit from adding more skills and, ultimately, be more satisfied at work? Below are some examples of qualitative results we’ve witnessed from the over 7,200 Research Sites using eBinders. Many of which have translated to the purely financial boost many organizations are seeking. Elimination of Binder Rooms With less paper-based processes, many of the organizations we’ve worked with have eliminated rooms dedicated entirely to binder and paper storage for both active and legacy studies. Many organizations leverage this freed up space by transforming it to various uses such as patient rooms, more space for teams to spread out and focus on essential tasks, and for housing specialized medical and scientific equipment required for precision medicine research. In addition, many of the large-scale multisite organizations we work with were using off-site secured storage for legacy studies. Just imagine what those costs per square foot would be in New York City, for example?
The ROI of an eRegulatory Platform
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Expansion of Catchment Area Cloud-based and access controlled eRegulatory technology allows research organizations to expand to additional physical research sites both in the community and globally without adding staff to the sites. These sites are empowered to utilize this technology resulting in faster site activation, study startup, and more consistent and streamlined regulatory workflows over time and throughout the study.
Addition of Remote Teams Now more than ever, the ability to work from anywhere and at any time is essential, and the value cannot fully be appreciated yet. Besides giving your current staff the ability to carry on despite any business continuity disruption, research organizations can now recruit and work with sought-after team members from anywhere in the world.
Optimization of Existing Technology An eRegulatory technology with an open API for integration with job-critical and legacy technology like your CTMS lessens the toggle time between disparate systems. According to research by Pegasystems, Inc., “The average employee switches between 35 job-critical applications more than 1,100 times every day resulting in lost productivity.” We can safely assume it takes no less than 5 seconds to switch between applications, which is 5,500 seconds per day, according to this research. Now, let’s say half of that accounts for switching from one application back to a CTMS, which is 2,750 seconds or 46 minutes spent per day just on opening the CTMS application for duplicative work. In our example, this ensures a Coordinator using eBinders for half of what would otherwise be duplicative work, the organization avoids nearly 4 hours of lost productivity per employee per week.
The ROI of an eRegulatory Platform
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Reduction of Employee Turnover Costs Not only will a technology-driven research site help team members optimize their day-to-day work and increase skills for their own career trajectory, but its very existence saves costs associated with employee turnover. Universal insights and advanced reporting and audit trails found in eBinders, for example, ensures that a single source of truth and repeatable processes are maintained regardless of site turnover, PI turnover and monitor turnover. Monitor turnover continues to plague the industry: “In 2018, CRA turnover rates in the U.S. reached a five-year high of nearly 30%,” according to a new report from BDO USA, LLP. With clear insights into the previous monitor’s activity and monitoring progress, a new monitor logging into eBinders can essentially pick up where the last one left off without burdening the research site. Elevation of Industry Reputation Having an essential clinical research technology like eRegulatory at your research site is a powerful factor for being selected for a study by a CRO or sponsor. eRegulatory gives these stakeholders advanced ability to easily extract and review data and documents, understand the research site’s productivity and study timeline levels, and finally, contributes to the overall ease of doing business with your site(s). For a Sponsor, this is more poignantly expressed in the findings summarized in the March/April Tufts CSDD Impact Report, which found that “the clinical site initiation process—time needed to identify and select sites and begin studies—takes an average of nearly eight months, longer than it did a decade ago, and remains inefficient.” The research continued stating, “[The] total duration from site identification to study start-up completion is 31.4 weeks, one month longer than the average duration observed 10 years ago. 28% of engaged investigative sites are new relationships with no prior history or familiarity of working with a CRO or sponsor, a proportion that is expected to increase as more clinical trials focus on rare diseases and highly targeted patient sub-populations.”
The ROI of an eRegulatory Platform
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As precision medicine and immunotherapies are becoming the forefront of clinical trials, sites are tasked with triple the workload without triple the resources. Purpose-built eSource and regulatory tools allow centers to scale and optimize document management, provide oversight and increased visibility for project management, ensure compliance, and become the central hub of all trial tasks from startup to closeout. We discovered that return on investment spanned seven areas, specifically , resulting in a positive economic impact of nearly $20,000 per study.
Conclusion
Custom ROI Analysis Our team can provide you with a custom ROI analysis for your site, CRO, or Sponsor based off your unique situation.
Email us at info@florencehc.com to learn more and discover Florence eBinders™
The ROI of an eRegulatory Platform
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About Florence Florence eBinders TM is a fully compliant eRegulatory and eSource Solution.
Accelerate Study Startup
Scale Compliant Processes
Enable Remote Monitoring and Access
Review and Approve Documents Quickly
Maintain Part 11 and HIPAA Compliance
Edit Documents with Confidence
Accelerate Study Startup Speed tasks, assignments & tracking Establish customized workflows Secure data with permission-based roles Enable Remote Monitoring and Access Control Gain instant access for audits and inspections Use computer, phone and tablet Maintain Part 11 and HIPAA Compliance - Guaranteed Capture EMR patient charts automatically Document events with audit trails Rest easy—Accepted by major sponsors
Review and Approve Documents Quickly Assign and track electronic signatures
Edit Documents with Confidence Redact, edit and capture data Boost output with Microsoft Office integration Scale Compliant Processes Lock in your standard operating procedures Grow with unlimited storage and user counts
Learn more about Florence | Email us at info@florencehc.com
The ROI of an eRegulatory Platform
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