How Will Risk-Based Monitoring Coexist With Other Clinical Trial Technology?

We’ve been really enjoying hearing your thoughts on the latest Risk-Based Monitoring hot topics over the last few weeks, so thank you to everyone who has taken time out to be involved. Next on our agenda is technology. As Risk-Based Monitoring takes off and becomes more mainstream within clinical studies, how will new technology exist alongside the multitude of electronic systems already in use? Will we see an evolution of technology or are some systems at risk of becoming obsolete?

We put these questions to some of our partners during our recent Q&A series and Angie Maurer, Co-Founder & CEO, Zynapsys summed up the general consensus of the group when saying, “we are likely to see the evolution and integration of current systems to incorporate Risk-Based Monitoring capabilities, as well as the introduction of new technologies.” James Streeter, Senior Director of Life Sciences Product Strategy at Oracle Health Sciences also quite rightly pointed out that, “studies can last for many years, so the systems being used in current trials or those beginning soon, will need to co-exist with new solutions introduced to the market over the coming years.”

Most colleagues we spoke with discussed the probability that current clinical trial technology will have to evolve over the coming years to incorporate Risk-Based Monitoring capabilities or risk becoming obsolete further down the line. In fact, many discussed the likelihood that going forward, providers of existing solutions, such as EDC, CTMS or site monitoring technology, will need to work together to integrate their systems to create larger, comprehensive Risk-Based Monitoring platforms for the industry. Angie Maurer was passionate about this potential for collaboration, saying that, “by working together in partnership, companies specializing in different areas, for example, EDC and monitoring, can create powerful new solutions for the industry.” Angie went on to say that in an industry saturated with specialists, all of which have spent years developing a deep understanding of their customers and markets, it is unlikely that one company will be able to provide the best quality solution in all the areas needed.

What are your thoughts on industry collaboration?

While everyone we spoke with agreed that clinical trial technology needs to – and will – evolve over time, many pointed out that there is likely to be a considerable period of transition for the industry, while companies work to make this change happen. Commenting on this, Adam Butler, Senior Vice President, Strategic Development & Corporate Marketing, Bracket Global said: “Pharmaceutical research is at least one generation behind in terms of the adoption and integration of new technologies, so it needs to play catch up.” Craig Serra, Senior Director and Data Management Business Process Owner at Pfizer, agreed, saying that, “given our industry’s track record when it comes to the adoption of new processes and ideas, I think there will be a coexistence of all this technology for at least a decade, if not two or three.”

As a provider of enabling technology to drive Risk-Based Monitoring and Data Quality Oversight, CluePoints sees that whilst there is still a huge amount of process change required to fully exploit the technological advancements, many sponsors are finding that they are still able to use existing technology today to improve data quality. Further, periodic assessments of both operational and clinical data quality is helping to improve the way in which data is collected using existing, incumbent technology. Several companies, that are now invested in RBM, are making a big step by looking to implement a workflow for an enhanced data interrogation and monitoring process that is a hybrid of new and existing technology tools. If anyone wants to receive more information about this approach then please get in touch and we would be delighted to provide an overview of how these seamless links have been implemented.

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