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European Pharmaceutical Contractor

Cause for Control

When companies are challenged to gain control over their finances across studies, it is usually because they lack insight into the disparities that exist between their budgeted expenditures, negotiated contracts and actual payments. Without a method for automatically accessing this information, they will always struggle to keep trials on track and ensure compliance with global transparency requirements. Additionally, the industry’s fragmented and manual payment processes impose even heavier burdens on budgets and timelines, and escalate the need for strategies to cope with increased legislation.
In light of these challenges, it is important to develop an end-toend solution to manage investigator budgets and the complete clinical trial payment cycle. By integrating payment optimisation technologies, data is able to flow in a closed loop from the initial budgeting stages right through to payment reconciliation.

Investigator Budgets
Getting clinical investigator payments right is one of the most challenging aspects of running a clinical trial. Offering fair market value to investigators, and ensuring accurate and prompt payments, are both essential in maintaining strong relationships and ensuring trial progression. Once investigators for a new study have been identified, organisers have the task of defining what the appropriate remuneration is likely to be. This will depend on a number of factors, such as:

  •  Country in which the study is taking place
  •  Type of institution
  •  Therapeutic area
  •  Phase and length of the study in question
  •  Complexity of the trial protocol

For example, highly complicated oncology studies tend to be more expensive than cardiovascular studies, due to the more intricate processes that physicians manage.
With the rise in transparency reporting requirements over recent years, making certain that investigator budgets and payment records are correct has become even more important. This year, the need for life sciences companies to document monetary transactions has dramatically increased with the implementation of the US Physician Payment Sunshine Act (Open Payments). Drug and device manufacturers are now required to track payments made to healthcare professionals (HCPs), meaning that they need to gather financial data at a highly granular level. As many of the contracts vary significantly between physicians and companies running clinical trials, sponsors and contract research organisations (CROs) are struggling to see where to pull this level of data from in order to submit their first federal reports by 31st March 2014. Looking beyond the Sunshine Act, there are now over 75 countries with complex regulatory requirements related to payment disclosures – all of which must be considered by sponsors working in the global arena.
A critical component of the new transparency requirements is ensuring that payments to HCPs are consistent with fair market value in the region in which studies are being conducted. It is essential for sponsors and CROs to have good background data on what their peers in the industry are paying, necessitating the need for a wideranging, detailed cost-benchmarking database that can help drive the creation of country-level budgets. These systems help to inform contract negotiations and enable sponsors to garner independent reassurance that they are not underor over-paying investigators.
However, despite offering extensive data related to global clinical investigator grant costs, these solutions do not typically track actual costs or link to payment systems. Consequently, they do not offer the capability to make comparisons between budgets and actual payments. This makes finding sources of variance difficult, and means clinical trial managers are unable to be proactive about updating budgets, or predicting and addressing sources of higher costs. Considering these factors, it is a highly complex process for sponsors to benchmark, negotiate and finalise contracts, as well as issue thousands of payments – often manually – to a worldwide set of investigators, promptly, transparently and accurately. Processes are also being compromised by the inability to access a complete picture of how actual study expenses are lining up, or how they accrue over time.

End-to-End Solution
In a rapidly changing landscape, sponsors are demanding increasingly complex support. With payment data and background information that is integral to the efficient running of a study often being housed in disparate sources, technologies to bring this information together are vital. We believe that a strategic integration of a web-based payment technology, and a benchmarking and online negotiation tool is needed. The two technologies independently offer numerous advantages and, by building an integration, sponsors should be able to gain further control over the costs associated with clinical trials. An overview of how web-based payment platforms and benchmarking and online negotiation tools work follows.

Web-Based Payment Platforms
Web-based payment technologies can accurately facilitate payment calculation and manage complex payment approval processes, while automating payment execution in local currencies. They can significantly reduce the time and resources needed to calculate, approve and deliver site payments, while also producing the complex reports – including aggregated reports – needed to make disclosures required by global transparency laws. These systems can not only record or keep track of why a payment is being made, when it is due and how much it needs to be – but additionally, who the payment will be approved by, when it is approved, the subject’s identity and the therapeutic area.

Benchmarking and Online Negotiation
Benchmarking tools for global clinical grant costs contain extensive data related to investigator payments at the cost-per-procedure, cost-pervisit and cost-per-patient levels from around the world, including emerging countries. They can provide in-depth insight into current fair market value for investigator grant costs and offer an online negotiation tool for finalising investigator contracts. By having the capability to manage the contracting process online, the task of negotiating with various sites can be expedited, while offering the additional benefit of being able to track the negotiations back and forth electronically.
Bringing these two technologies together means that all work done by the benchmarking tool can be leveraged by the payment platform. For example, the benchmarking tool’s country-level budgets can be fed directly into the payment technology, creating comparative reporting to illustrate expected costs versus actual costs. To complete the cycle and create a seamless exchange of data between the two technologies, the payment platform automatically shares all contract and rate information that it gathers with the benchmarking tool, including all the ongoing contract amendments that routinely take place. This provides the benchmarking tool with a much more comprehensive dataset.

Closed-Loop Solution Benefits
The integration of the two technologies will enable clinical sponsors and CROs to achieve faster study start-up. By implementing a benchmarking and negotiation tool with a payment platform, there is no longer a gap between the two processes, creating a true ‘plan-to-pay’ lifecycle. Sponsors and CROs will be able to proactively identify and mitigate unplanned expenses throughout a specific study, and better anticipate budget variance in future trials. An added benefit is that users will also be offered the capability to precisely evaluate the performance of third parties responsible for negotiating contracts.
The payment platform will ultimately execute settlements in local currency within the various global sites around the world, making the lowest level granular payment detail available to sponsors, and sharing this with the benchmarking tool to complete the loop. In addition, future benchmarking clients will have confidence in the fact that they are using data to drive their planning activities that is not only comprehensive, but is as reflective of reality as possible.
The advancements will provide clinical trial managers with the tools they need to stay informed about how study expenses are lining up with budgets, in real-time, and accurately project future expenses against budgets. This will help to automate the contracting, negotiation and payment management environment, while also equipping sponsors with the data needed to make informed decisions – enabling them to course-correct and take action in the present to control costs in the future.

Industry Reassurance
The need to accurately track financial relationships with HCPs is fast becoming the industry norm, and new transparency requirements make it essential that every sponsor and CRO has in place a consistent and supportable methodology underlying their investigator payment processes. This calls for systems that can ensure accurate payment information, spot issues, and manage contacts and accounts in a streamlined way.
The capability to automate processes across the entire investigator payment cycle – through the integration of a webbased payment management platform and a rich benchmarking database – will provide reassurance to an industry faced with tough reporting demands. Delivering a solution that enables data to flow in a closed loop through the entire investigator payment process, from initial budgeting to payment reconciliation, will no doubt help sponsors to keep their trials on track while remaining compliant with global regulations.

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About the authors

Linda Drumright is General Manager, Clinical Trial Optimization Solutions for IMS Health, and responsible for delivering optimisation products, services and data to clinical trial sponsors and CROs worldwide. She joined IMS in 2012 with the acquisition of San Francisco-based DecisionView, where she had served as President and Chief Executive Officer since 2010. Linda holds a BA in Computer Science from the University of California, Berkeley, and completed the Haas School of Business Executive Program.

Sam Whitaker is the founder and Chief Executive Officer of Greenphire, the industry-leading provider of global clinical payment technologies. Since the company’s inception in 2007, he has brought together his knowledge of clinical trials with his experience in managing and developing payment solutions, to develop technologies that help clients improve operational efficiency.
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Linda Drumright
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Sam Whitaker
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