HEAD OF GLOBAL COMPLIANCE, LEADING MEDICAL DEVICES COMPANY
When it comes to healthcare professional and organization (HCP/O) engagements and the numerous related transparency requirements, many companies feel like they are in an uncertain place. It is known that consistent, uniform streams of data from multiple sources are the cornerstone of reliable, transparent HCP/O engagement tracking and reporting. However, in the real world, corporations are often faced with inadequate systems siloed across a global hodgepodge of use cases and hobbled by uncertainties surrounding commercial processes, compliance controls, and accurate reporting.
Aging and disparate systems motivated our customer, a leading innovator of less invasive medical solutions, to pursue significant changes in HCP/O engagement and Transparency Reporting. “Our IT team would affectionately refer to them as ‘ticking time bombs’,” says the company’s global compliance leader. “They were running out of maintenance. We knew we needed to ultimately replace them.”
Like every other provider of medical therapies and devices, our customer interacts with healthcare practitioners and organizations in any number of ways – across advisory boards, consulting arrangements, congresses, and more. Every one of those interactions is subject to intense regulatory and compliance scrutiny – scrutiny that can differ from one jurisdiction to another and that is constantly evolving and adopting new rules. This makes compliance a multifaceted, global issue for large multinationals like our customer. “From a strategic perspective, we were looking to implement systems which can be scaled globally, which will allow us to harmonize processes,” the compliance leader adds. “So, in terms of compliance, we started looking at adopting a comprehensive solution that would address all of our systems moving forward.”
In the face of HCP/O engagements and transparency regulations that only continue to grow in number and complexity, clients seeking seamless commercial compliance turn to IQVIA for guidance. Leveraging best-in-class technology, strategic guidance, and comprehensive services, IQVIA’s HCP/O Engagement and Transparency Reporting (ITR) platform helps organizations optimize compliance and reporting while also improving business efficiencies and processes. For this client, IQVIA’s compliance experts delivered a comprehensive solution that supported their unique challenges and complexity. IQVIA’s Software as a Service (SaaS) solution integrated with their applicable proprietary systems, enabling a more uniform approach for the company’s HCP/O engagements and regulatory reporting to drive a range of value, including:
The platform is supported by dedicated legal experts that systematically track more than 320 reports and 40 industry codes at the national, state and city level. From U.S., Italian, and French Sunshine, to EFPIA, MedTech Europe, Dutch Registry, and more, our ITR reporting solution supports all our customers wherever they do business. “We knew we wanted to partner with someone who had a global footprint,” the company’s compliance leader says. “There are a lot of evolving regulatory needs and we needed to partner with someone who was going to help us stay on top of them.”
Deploying a new, extensive compliance platform can be challenging and our customer addressed those challenges head on. The company’s compliance leader credits an agile development approach and many months of proactive change management as critical factors in the company’s successful transition. “It was really critical that the IQVIA team was building the tool in a very agile manner,” he says. “That enabled us to scale our rollout in an agile manner as well.” For example, at launch, the company first went live with limited functionality for just one business unit. This enabled the organization to collect feedback before rolling out the platform more broadly so that issues could be worked out early on.
The agile rollout approach not only enabled the company to capture critical information that helped fine-tune the overall deployment, but also demonstrated the way to “training folks smarter and supporting them after the platform went live,” as the compliance leader puts it.
From the commencement of planning and development, he and his team embraced and broadly communicated the forthcoming transition to IQVIA’s compliance platform and the impacts that it would have on all stakeholders across the organization. “We brought SMEs in from across all of our divisions where they were going to be using the tool,” he says. “And we really tried to make them feel heard as far as what their needs were, but then also trying to get them to understand we’re all going to have to adapt as part of this process. That’s one of the reasons we’re going to a tool like this, to harmonize and get everyone following the same process.”
Maintaining engagement with all stakeholders impacted by the new platform continued throughout the entire 16-month development phase. Thanks to this collaborative effort the new users acclimated to the new systems and by the time of launch, “people throughout our divisions, knew it was coming; as we’re getting close to going live, it’s not catching anyone off guard,” says the compliance leader. “With change like this, not everything is simple. But I think overcommunicating and being transparent through change management was very critical.”
By emphasizing clear and consistent communication and always being up front about what the company was trying to achieve, the people most impacted by the new platform eventually became the ones that were most excited to put it to use – and they are now the ones reaping the productivity and efficiency benefits.
Almost immediately, the new platform enabled a range of business and compliance benefits. From the outset, one of the company’s primary objectives was to be able to embed legacy compliance controls that were currently in place and were critical going forward, but were at the time being implemented manually. Setting this up required reading through a lot of documents and ticking off endless checklists, but now that those controls are embedded into the system, our customer’s compliance leader says compliance and validation are “happening in a far more efficient manner and are meeting the needs of our customer-facing employees, who are moving faster than ever.”
As one example of the new platform’s success, the compliance leader tells of one centralized team that previously had to manually comb through a large queue of requests from six different divisions. Under the old system, “we’d try to turn a document around as fast as we could, but on average, it would take us about ten days.” Now, with controls embedded within the system, the six divisions are essentially able to help themselves by simply filling out a form and receiving the information they need with the click of a button. “What used to take them more than a week to get back from my team now takes only as much time as needed to fill out the form and generate the document themselves,” says the compliance leader. “So, ten days is down to less than probably an hour.”
Successfully wrapping up the initial rollout, our customer is already looking to the future and thinking about how best to scale the new compliance platform into additional regions. The company is also discovering how easy it is to expand functionality to include grant portals and other time-saving mechanisms and to respond quickly to evolving realities, such as an OIG Special Fraud Alert or mandated updates. The compliance leader notes that his company is prepared for new Sunshine Act regulations requiring manufacturers to report payments to more categories of recipients. “We’ve always tracked that information,” he says, “and now IQVIA puts it all at our fingertips and makes compliance easier than ever.”