clinverse white paper - embracing clinical trial technology (web)

Embracing Clinical Trial Technology: The Necessity of Financial Lifecycle Systems

Heather Schultz, Vice President, Product Solutions, ClinverseTim Immel, Chief Product Officer and Founder, Clinverse

© 2015 Clinverse, Inc. • 1.877.325.1122 • www.clinverse.com 1

Introduction

The automation of clinical trials has been an ongoing evolution, and one that benefits the collection of trial and study management data.

Over the past decade, the industry has eliminated many manual processes, such as the handling of paper case report forms and the time-consuming process of double data entry with electronic data capture. In fact, an industry report suggests the clinical trial technology sector could top $5 billion by 2018, especially as globalization, outsourcing of clinical trial processes and trial complexity continue to increase.1 With each advance in technology, clinical trial sponsors and contract research organizations enjoy ever-finer degrees of transparency over all aspects of study execution.

However, even with all of these improvements, there are still major pockets of manual processes within clinical development that need to be automated.

History

Technology has been a great boon to the clinical trial industry and still has a richer role to play.

In the 1960s when companies became large enough to afford (then) cutting-edge technologies including mainframes and mini-computers, it first became possible to count and track the many reams of data collected during a clinical trial within a database.

In the 1970s and 80s, the clinical trial technology revolution continued with widespread adoption of Interactive Voice Response Systems (IVRS), layering new functionality over old technology—specifically enhancing the power of the telephone already located at every clinical trial site. Through complementing telephones, IVRS were able to assist clinical trial sponsors in enrolling and randomizing clinical trial subjects as well as managing site supplies.

IVRS also gave clinical trial sponsors the first real-time window into the status of clinical trial enrollment.

The next logical evolution for automating the management of clinical trial data took shape in the emergence of clinical trial management systems (CTMS) in the 1980s and 90s. CTMS represented a major advancement in the oversight of clinical trials as they brought automation to hundreds of study document management elements that used to be tracked using a range of paper files and spreadsheets.

By using CTMS, trial sponsors could better manage a wide range of study documents and data points, including regulatory document tracking and management, study timeline tracking, site and subject tracking, study status tracking, study resource management and reporting.

And CTMS became even more powerful when the capability to link sets of studies together was introduced, allowing for a program-level view of study progress.

A Timeline of Technology in theClinical Trial Industry

Widespread adop�on of Interac�ve Voice Response Systems (IVRS)

Widespread adop�on of EDC

Introduc�on of Electronic Data Capture (EDC)

Emergence of clinical trial management systems (CTMS)

Introduc�on of cloud-based services1970s

1980s

1990s

2000s

2010s

A Timeline of Technology in theClinical Trial Industry

Widespread adop�on of Interac�ve Voice Response Systems (IVRS)

Widespread adop�on of EDC

Introduc�on of Electronic Data Capture (EDC)

Emergence of clinical trial management systems (CTMS)

Introduc�on of cloud-based services1970s

1980s

1990s

2000s

2010s


In addition, the Internet’s growing availability in the 1990s proved to be transformational for clinical trial technology. While databases had been around since the 1960s, sites still recorded clinical data on no carbon required (NCR) forms, which were manually collected and shipped to a central site. Once they arrived, information was taken off of the NCRs by hand and then entered into a corporate database — a manual process that proved both time-intensive and expensive.

Electronic data capture (EDC) soon emerged as the next clear iteration in clinical trial financial software. It allowed sites to enter data into a proprietary system over the Internet. Monitoring was still required, but EDC eliminated lag-time in the availability of real-time data and opened up more possibilities for real-time decision-making and adaptive approaches to trial execution.

Ultimately, EDC made the collection of data easier and less expensive, so sponsors could better comply with increasing Food and Drug Administration requirements calling for information.

Now Sponsors can now leverage the use of cloud-based technologies to align themselves of a wide range of information systems that have various roles in automating clinical development. These current technologies make the process of conducting clinical trials more efficient, and include:

• Study supply management and tracking systems. These support the complex process of manufacturing specialty study supplies, labeling them correctly and handling the logistics for shipments and eventually collecting from sites as necessary.

• Electronic trial master file management systems. These document management solutions ensure that the thousands of study documents are electronically filed and controlled.

• Protocol automation technology. These support the creation, review and approval of protocols.

Bridging a Big Technology Gap

However, despite significant advances, there are still significant areas within clinical development that would benefit from automation and technology solutions. The manual efforts behind cobbled-together processes are not only error-prone, but also require an enormous amount of time. This is particularly evident in Phase III clinical trials, which saw a 70% increase in length from 1999 to 2005. 2 In addition, the BioPharma industry has seen an overall lengthening of total clinical development, which is an estimated 6.8 years, up from 6 years in the 1999 to 2001 timeframe, a 13% increase.3 Initial efforts to reduce cost have focused on protocol design and changes in monitoring activities. While accepted in principle, the introduction of technology to lower cost, improve delivery and reduce time is more difficult to measure in terms of ROI.

The Length of Clinical DevelopmentSince 1999

2000 2005 2010 2015

13% increase

Num

ber

of Y

ears 6.8 years

6 years


However, as clinical trials extend their global reach and increase in complexity, many believe the industry has reached a tipping point and must now embrace technology in order to streamline clinical trial activity.

But in order to have a true end-to-end solution, it would need to marry automation of data evaluation with the data source of truth and use the evaluation outputs to transition through the lifecycle of a trial or program. One major gap in this transition is in financial visibility. Many processes are siloed and manual, making them inefficient in providing visibility into trial performance. As a result, there is limited financial visibility for sponsors, CROs and sites. Operational performance is often discussed as the key to a successful trial, but all of that is linked to the contractual and financial cost of execution. Sites want accurate and timely payments for the operational work performed; sponsors want to know what the expense picture of their trial looks like; and CROs want to be able to give their clients real-time options to affect trial outcomes rather than trying to minimize the impact of something that is already done.

This is evident by the number of financial processes still relying on spreadsheets. Spreadsheets should be a last resort as they present a number of problems for trial sponsors because they require manual maintenance, uniformity, and consistent controls. They are also prone to accidental transcription errors and other inaccuracies.

Even today, the financial lifecycle of clinical trials (budgeting and forecasting, contract management, site payment generation, site/subject payment management, accounting, accruals, and reporting) is still greatly dependent on spreadsheets. Proving this point, 70% percent of companies reported in a recent Clinverse study that their primary tool used for budgeting and forecasting is Microsoft Excel.

While some companies have automated individual pieces of their financial lifecycle, these disparate systems are rarely capable of talking to each other. For example, a company might track budgets in a financial system and track contracts in a document management system, and then use CTMS to track some site payment information. Meanwhile, actual trial site payments are executed and accruals are tracked through separate spreadsheets or an ERP system that is not integrated with operational systems and/or data. And when automated pieces of the financial system don’t communicate, spreadsheets — with all of their flaws — become the default intermediary between them.

The solution? A truly complete financial lifecycle system.


An Overview: The Financial Lifecycle System

A financial lifecycle system (FLS) is a new type of software that handles the global financial aspects of a clinical trial:

• The process begins by automating the budget consolidation and performing ‘what if scenario simulations.’

• The budget then becomes the basis for contract negotiation where each contract term, whether listed in an SOW or a term listed in the site study budget in the Clinical Trial Agreement (CTA), is agreed to and becomes the basis for financial transactions.

• The finalized contract terms are analyzed against the source operational and EDC data (record of truth), and upon a term being fulfilled, a financial transaction is generated.

• Financial transactions are managed with internal routing and approval, and ultimately, payment is made to the vendor.

• Transactions are aggregated for GAAP (general accepted accounting principles) accounting and transparency reporting, providing your partner with the ability to view the financial status of their payments.

• Actual data is then analyzed by the forecasting and planning engine and used to perform re-planning simulations.

One of the great values of an FLS becomes clear when site payments are considered. By some estimates, sites are paid more than 90 days after they have completed the contractual work that qualifies them for payment; and this is an understandable frustration for sites that have to pay their own bills in 30 days.

In order to automate investigator payments, an FLS payment system determines when a site has qualified for a payment and how much money is due under the contract terms. But to accomplish that, a site’s contract details must be coded into language that a software solution can understand. From that point, the FLS applies the contract language against the actual data found in other systems, including EDC, IVRS, CTMS and any other eClinical system. Going to the source of truth removes the need to bounce data from one system to another, a timely process that opens the door for manual error, and also provides a unique view into site performance. It’s also important that the system understands and tracks unique aspects of site contract including holdbacks, caps, and invoiceables.

Once a site’s trial payment has been triggered and quantified, an FLS supports a range of disbursement processes based on the necessary roles and authorizations required for the size and amount of payment. To enable full automation, the FLS is able to interface with financial networks to allow for seamless automation of electronic payments. By linking the financial data to the operational performance or activity, one can illustrate a true financial picture of the trial.

An FLS also includes a generally accepted accounting principles (GAAP) accounting system tying in to the corporate general ledger system. The FLS accommodates industry regulations, such as the Physician Payment Sunshine Act, while also working with other systems to combine payment data into a seamless whole.

Budget management and forecasting is another area where an FLS provides immense value. In the typical process for forecasting expense and study duration, the site feasibility survey that is used for site selection becomes the primary tool to estimate enrollment per site, and enrollment is forecasted on a straight-line bases. However, our analysis shows that more than 80% of clinical trial costs are associated with the timing of site readiness (this is the date sites can begin enrolling subjects) and subject enrollment.


With an FLS, users can define any milestone date, which can be referenced by any user-defined activity or task, to automatically reforecast the future expense date as key user-definable dates are updated. This enables financial managers to calculate expense and cash forecasts as well as timing by changing linked key dates. Dynamic amounts change based on linked assumptions change, such as the number of monitoring visits. Further, the system can generate an expense and cash forecast and designate a primary budget to compare and report against actual results.

And like other modern systems, an FLS supports robust reporting that will drill down into financial details.

Conclusion

Over the last couple of decades, the clinical development industry has leveraged technology to conduct trials faster and more affordably with greater efficiency. But there is still a need for widespread adoption of automation and technology when it comes to the financial aspects of clinical trials.

Much of the financial side of clinical trial operations remains heavily dependent on the manual development and maintenance of error-prone spreadsheets. It’s time to recognize how a robust and flexible FLS can eliminate errors and increase efficiency by automating the last vestiges of manual processing.

Ready to say no to more spreadsheets? Contact us to learn how the Clinverse FLS can automate and accelerate your clinical trial payments process.

[email protected] 1.877.325.1122

References

1 Taylor N. P. The clinical trial technology sector could top $5B by 2018, report says. January 26, 2014. Accessible at: http://www.fiercebiotechit.com/story/clinical-trial-technology-sector-tipped-top-5b-2018/2014-01-26.

2 Gaffney A. Report: Phase III Clinical Trials Behind Increase in the Cost of Pharmaceuticals. April 25, 2013. Accessible at: http://www.raps.org/focus-online/news/news-article-view/article/1359/report-phase-iii-clinical-trials-behind-increase-in-the-cost-of-pharmaceuticals.aspx - sthash.XUuVoQPm.dpuf

3 Morrison R. Technology’s Role in Clinical Trials. March 5, 2015. Accessible at: http://www.appliedclinicaltrialsonline.com/technology-s-role-clinical-trials - _edn4.

© 2015 Clinverse, Inc. • 1.877.325.1122 • www.clinverse.com

Clinverse, Inc. architected the industry’s first automated financial management technology solutions for clinical trials. Powered by our secure technology platform, our solution standardizes clinical trial finance and manages millions of financial transactions across the globe, including clinical site payments. Used by leading BioPharma companies, our clients benefit from reduced workload, time, and costs gained through automation and unprecedented transparency and workflow. For more information, please visit www.clinverse.com.

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About Clinverse, Inc.

clinverse white paper - embracing clinical trial technology (web)

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