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In association with Hexaware Technologies
  1. Technology
July 1, 2022updated 05 Apr 2023 8:03am

How clinical trials infrastructure is undergoing digital transformation

The pandemic highlighted the need to better recruit and engage patients for clinical trials – and, as Hexaware’s Srini Marimganti discusses, has encouraged a radical re-think of data management.

Two years ago, many of us were confined to our homes trying to avoid Covid-19 and waiting for the pharmaceutical industry to develop effective vaccines faster than ever before. The usual, time-consuming process of drug development and approval had to be overhauled, and the ramifications of that reshaping are still being felt today.

“That was a pivotal moment in the world of pharma,” says Srini Marimganti, VP Life Sciences & Healthcare at Hexaware. “The pharma industry had a responsibility to solve this problem very differently, so it went back to the drawing board, beefed up the research process and looked at all kinds of options.

The pandemic highlighted the need to better recruit and engage patients for clinical trials and has encouraged a radical rethink of data management. (Photo by PeopleImages/iStock)

“They took the risk of not just validating that the technology worked, but also of making sure that if it did, it could produce millions of vaccines straight away,” he adds. “The industry has come together in a phenomenal way to accelerate what they never” attempted before – reduce the median time to deliver a vaccine to the market by a startling 94%

The industry has achieved something that no market leader, nor government achieved to date – compressing a typical drug development time frame from five to seven years to just eight months.

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“Essentially, the bar has been raised,” says Marimganti. “Drug development that takes five to seven years is no longer acceptable. Now, the drug development pipeline in the market is better than any other period in the past 20 years. There are 3500 new molecules being developed and 300 new drugs will be introduced in the next three years.” Pharma companies are at a pivotal point to deliver cures to those who need it sooner and more efficiently.

“To do this, pharma companies are reinventing themselves at breakneck speeds,” he adds. “Clinical trials are being reimagined as well.”

The future is virtual

One key effect of the “new normal” is the shift to a virtual or hybrid trial model, where patients either participate in clinical trials online or go to a site less often than usual.

“Everybody talked about hybrid clinical trials previously, but when the pandemic arrived it was the only option,” says Marimganti. “Pharma companies had to re-accommodate potentially hundreds of thousands of patients.”

“I know of one situation where a sponsor had about 10,000 patients on their clinical trial platform, and they had to scale up to more than 400,000 in a very short period of time” he adds. “That meant rethinking the entire technical architecture and business processes.”

This client had a virtual clinical trial platform for rare diseases, but, facing the challenge of scaling it up by a factor of 40, they had to rethink their processes for e-consent, patient outcome reporting( ePRO) and patient engagement. The firm accelerated the adoption of cloud platforms to scale the architecture to accommodate increased demand for virtual trials. They reimagined the patient engagement process through design thinking to develop empathy towards patient needs and render a seamless experience for online engagement.

“Firstly, they started with Patient Experience; reimagined the entire process of patient engagement in a virtual set-up”, Marimganti explains. The pandemic enabled them to take patients to the centre of entire re-imagination.

“The FDA has relaxed certain regulatory requirements to accelerate trials and provide conditional approvals for emergency use” he adds. “For patients to report the outcomes, there is no need to return to a site, and it could be done through tele visits or other electronic means.”

If the pandemic has rewritten some of the rules of clinical trials, then it gave forward-looking companies the chance to reimagine the art of the possible and include new functionalities to manage trials more efficiently. For instance, sponsors are embracing machine learning and deep learning for patient recruitment in clinical trials. For certain trials, this process has traditionally been like searching for a needle in a haystack.

Furthermore, around 50% of patients typically drop out of a clinical trial during the trial, but, with virtual or hybrid models, retention rates are greatly improved.

“Companies develop a competitive advantage only when they focus on driving business process improvement leveraging technology than a mere technology update,” says Marimganti. “Reimagining the patient recruitment process enabled pharma companies to identify the most suitable candidates for clinical trials two times faster than a regular traditional model. Machine learning helped them get there and not vice-versa.”

Clinical trials need the cloud

Patient recruitment, retention and monitoring in ever-larger clinical trials are improved through the use of emerging digital solutions, as Hexaware found in helping a leading CRO to digitally transform its end-to-end clinical trials infrastructure. Helping with trial design, start-up and conduct, Hexaware improved data management to yield better insight, then developed a custom digital patient recruitment portal and a patient onboarding platform and established a contact centre supporting 400,000 users.

The platform enabled 30% efficiency by addressing data quality issues. The recruitment process was twice as fast, with a 25% increase in patient onboarding levels and a 90% increase in document accuracy. Furthermore, the trial conduct phase led to a 25% improvement in reporting efficiency.

During the pandemic, Hexaware partnered with one of the largest CROs to accelerate delivering two popular vaccines to market. Hexaware leveraged its virtual trial platform developed on cloud to help accelerate the process.

“Pharma companies are adopting cloud technologies to manage their patient data and reported patient outcomes,” says Marimganti. “If they are leveraging an on-premise system, that data is very difficult to access quickly. So, companies are building their engagement platforms on cloud, but they need to also move their infrastructure into the cloud. That is another major massive shift that we are seeing.”

“Pharma companies have significant data on trials, real-world efficiency and commercial spread across the organisation, but they did not really have mechanisms to bring the data together,” he adds. “By moving to cloud within the guard rails of regulations, pharma companies can accelerate their ability to leverage data to drive more patient outcomes and research.”

During the last two decades, pharma companies focused on commercial data and longitudinal patient data. The next decade will be all about harnessing the power of connected data to build intelligence around patient journeys. Cloud will be an intricate and inseparable part of this evolution.

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