Bayer program streamlines clinical trial process, site relationships

By Jenni Spinner

- Last updated on GMT

(Suppachok Nuthep/iStock via Getty Images Plus)
(Suppachok Nuthep/iStock via Getty Images Plus)

Related tags Bayer Clinical trial Site selection Clinical research Pharmaceutical industry

Created via a joint effort with EY, the pharmaceutical company launched ASPIREs, a program intended to improve its clinical trial processes in numerous areas.

Pharmaceutical company Bayer recently joined forces with consulting and accounting firm EY and launched the Automated Site Payments and Invoice Resolution (ASPIREs), an effort designed to help Bayer and its site partners to streamline the trial process. According to EY, the results were notable—for example, Bayer’s average cycle time for payment dropped from 75 days to fewer than 35 and greatly reduced time on fielding payment-related questions and disputes left more time for more important matters.

To dig further into the program and its results so far, Outsourcing-Pharma spoke with Salman Shah, EY partner with life sciences and health consulting.

OSP: Could you please tell us some of the factors behind the drive toward pharma firms looking to forge preferred partnerships with sites and investigators? What benefits does such an arrangement bring to their drug development efforts?

SS: When sites have the option to select the clinical trials they participate in and which sponsors they partner with, building strong relationships and creating a reputation as "partner of choice," it is a key factor in the success of a pharma company’s clinical trial. These types of relationships – built on streamlined and highly efficient clinical trial processes – can reduce study startup time, drive cost avoidance, and improve time to market.

As a “partner of choice,” pharma companies also increase the volume of potential sites that would be interested in working with them, which can in turn expand the opportunity for diversity in clinical trials, allowing for more robust clinical trial outcomes.

OSP: Bayer recently approached you to explore some of the challenges in site management processes and timelines. Could you please share some of the concerns they expressed?

SS: The concerns Bayer expressed with their site management processes and timelines often involved a high burden on FTEs and delayed payment cycle times caused by pain points such as high effort involved to QC invoice line items, many manual processes, no real-time reporting, disparate data sources, and an overall lack of standardization. These types of issues are common within the site payment processes in pharma, and outsourcing parts of the process can allow for alleviation of these pain points.

OSP: Please tell us a bit about the ASPIREs program—how did you design it, deploy it, what did you learn, etc.?

SS: ASPIREs was designed in partnership between EY and Bayer. The first step was to assess the end-to-end current state of operations across study budgeting and start-up, contracting, invoicing, and site payments. We engaged members of the clinical trial management team, finance, accounting, tax, legal, and more to gain a holistic understanding of not just the process flows, but the requirements that would dictate feasible changes in the future state.

Using this foundation, we layered the technology partner's capabilities and standard processes to redesign the flow and drive automation. With buy-in on the new process from Bayer leadership, a handful of new studies were selected as pilots. In a subsequently iterative effort, we gathered lessons learned, refined the process, and expanded deployment until all new studies were using the ASPIREs process for site payments.

OSP: You mentioned that the ASPIREs program empowered Bayer and its partners to make some changes that led to notable results. Please tell us a bit about that.

Salman Shah, partner with life sciences and health consulting, EY

SS: A few of the specific changes that were made in the Bayer site management processes involved transferring parts of the Bayer QC responsibility to a third party, reducing the number of steps and templates, and providing real-time reporting all while ensuring compliance with local policies and overall global consistency. In the US pilot, these changes resulted in a quantifiable success across multiple metrics, including a 77% decrease in payment-related disputes, a 55% decrease in average payment cycle time, and a 97% overall reduction in FTE time spent on payment-related activities.

The global rollout of these processes reported similar success in participating countries, with site management teams being able to focus more of their time on impactful decision-making rather than tedious reviews and processes.

OSP: Could you please tell us about some of the chief lessons learned in the process, and how these might be applied to other research organizations looking to effect change?

SS: We had four key lessons learned, some of which became particularly evident as ASPIREs was expanded across the rest of the world:

  1. Strong governance will drive efficiencies and sustainable success​. With multiple partners engaged, inefficient communication amongst parties can delay progress toward project milestones. We solved this through establishing governance and a reporting structure and streamlining alignment on future state process development and solutioning.
  2. Communication, change management, and stakeholder engagement are essential to lasting change​. Teams are often reluctant to evolve beyond legacy processes, resulting in increased costs and delayed benefit realization. We solved this through co-creation of the new process with stakeholders, identifying champions to achieve buy-in, and offering user training and office hours.
  3. Local tax, finance, and regulatory knowledge is required for global implementation success.​ Variations in local tax/reporting regulations can delay alignment and require changes to the standardized future state approach. We solved this through early assessment of in-country complexities, particularly for the rest of the world, and early engagement with the local finance, tax, regulatory, and risk management stakeholders.
  4. Meaningful attention to efficient process redesign and transparency will allow accountability and acceleration​. Variations in local contracting processes, unnecessary process steps/duplication, legal entities, and templates can create complexities in future state standardization. We solved this through analytics-driven dashboards to enhance transparency and accountability, and incorporation of end-to-end site management best practices.

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