The time to modernise is now: Data managers and CRAs call for connected clinical workflows
In a recent industry research report from Veeva, data managers and clinical research associates (CRAs) detailed the daily inefficiencies they face and the need to modernise outdated manual processes and fragmented systems.
To discuss the findings more closely, pharmaphorum spoke with Manny Vazquez, Senior Director of Clinical Data Strategy at Veeva.
Quantifying the problem
The research quickly highlighted just how little understood the severity of the problem had been.
“[For] data managers, it’s not a secret that there is a lot of inefficiency going on, [but] it’s never been quantified before,” explained Vazquez. “There’s no budget for tools like a Clinical Database (CDB) and things that are meant to help streamline and automate that data review process because the leadership doesn't truly realise there is a problem that needs to be solved.”
There are, of course, data review processes already in place – which, for many, is a “box checked”.
“The two tasks that were flagged as having the most time spent are no shock to anybody: manual reconciliation and data review,” said Vazquez. “Certainly, some of the time they're spending is necessary because those tasks have to be done, so next we need to tease out how much of the time they're spending is ‘waste’.”
With support from the Society for Clinical Data Management (SCDM), Veeva distributed the survey to its membership, while CRA responses were gathered via internal channels.
Vazquez explained the criteria for participation:“We wanted people who were actively working on phase three studies and also had a couple under their belt already. If they worked on some phase three studies 10 years ago, then they were factored out because we wanted people that were actively doing it today.”
Circumventing stagnancy and risk with change management
As to why data managers and CRAs are still living in a manual and fragmented working environment when there are augmented working environments available, Vazquez believes this stagnation isn’t by choice.
“It goes back to what I said: there's no budget for new tools,” he explained. “It is boxes that a lot of leadership consider checked already, along with legacy processes that get the job done. They have a process for it, the process works. There is always something newer and more exciting that leaders are getting tasked with evaluating, so these kinds of things get left by the wayside.”
At the same time, however, change by its very nature is difficult.
“Change management is one of the major challenges because when you're looking at tools like the CTMS system that a CRA is going to use for their work, there's a lot of process that's built around that,” said Vazquez. “To just rip and replace a CTMS system is similar to if you were to try and rip and replace an EDC system or a lot of the data review workflow.”
Such a mindset, though, comes with risks.
“The most surprising metric that came out of the research was, for me, that 70% of the survey respondents called out data quality as their number one risk, which I thought was really interesting because data quality is everything,” Vazquez exclaimed. “If you can't stand by the quality of the data you're submitting to a regulatory body, then you have really, really big problems. Particularly with the release of the ICH E6(R3) guidance and the heavy push from virtually every global regulatory body for risk-based trial execution.”
Certainly, in order to support a risk based model for trial execution, the correct tools need to be in place. And that is down to leadership.
“These teams need more modern tools; they need updated SOPs and processes that can take advantage of those tools, and that's going to require investment – it's going to require change management,” stated Vazquez. “No one that we've presented the findings to has been surprised by them. We presented a poster at the SCDM North America conference in Baltimore [and] not one person was shocked by the number of hours that were being spent and the number of people that were doing the work outside of the clinical system.”
Indeed, the survey found that 97% were working outside of a clinical system or with a mix of systems.
“They need a leader to drive this change. We change this top-down,” stated Vazquez. “There are ways to minimise the upfront cost as much as possible to expedite the ROI, but it's an investment nonetheless and it is hard. Change is hard, but that is simply the cost of doing business if you want to elevate yourself, if you want to elevate your organisation.”
That doesn’t have to be an AI overhaul, however.
“What a lot of people are trying to do now, because they have these mandates and they're trying to figure out how they take a complex thing like AI and stack it on top of an already complex process. And you know, as my colleague Drew Garty [Chief Technology Officer, Clinical Data, Veeva] likes to say, stacking complexity on top of complexity is never going to yield you something that's more efficient or better. It's just going to make the problem worse.”
An evolution as yet unfolding
With data managers leading this transformation from complexity to greater efficiency, the CRA role will necessarily evolve to suit alongside. The pandemic went a long way to facilitate a more if not remote, then hybrid role, certainly.
“We see now the advent of central monitoring teams where you have remote employees who can do a lot of the site monitoring reviews based on data coming in remotely. They can feed that into their risk assessments and mitigation strategies,” said Vazquez. “The CRA of the future is going to be less of a road warrior, and more of a strategic partner for the site they’re working with. I think it's an interesting time for clinical development leaders in general – we’re at the forefront now. AI is now going to be that next pivot point of how we decide to utilise AI. This is going to then dictate how we do trials for the next 20 plus years.
“Are we willing to take on the necessary change in order to make sure that our foundation is set?” Vazquez mused.
About the interviewee
Manny Vazquez has spent 20 years in the research industry, the majority dedicated to Clinical Data Management. He began his career in small oncology biotech before moving to the CRO space for 10 years where he spent his time in DM leadership, focusing on high-profile strategic partnerships and driving innovative initiatives. In Feb 2022, Vazquez joined Veeva Systems to support the strategy for Veeva's Clinical Data suite of applications. Vazquez currently sits on the Society for Clinical Data Management Board of Trustees.
About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest biopharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com.
