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Decentralized Clinical Trials – the 2020s’ Digital Transformation Driver

Updated: Sep 29, 2021

Guest blog by Venu Mallarapu, Senior Director, Life Sciences/Global Head of R&D Solutions, Cognizant

While most industries have suffered immense disruption during the COVID-19 pandemic, the life sciences industry has been under more pressure than most to sustain operations as usual. Maintaining normal lines of supply, and accelerating the delivery of new medicines and vaccines, have been paramount to protect lives.

Yet restrictions to routine ways of working have presented a very real challenge to these ambitions. This has been the case particularly in clinical research - as isolation, social distancing, and remote working have prevented or deterred patients from visiting sites in person. While, on the one hand, major efforts have been made to fast-track new drug/therapy/vaccine approvals, there has been a risk of delay to processes earlier in their development/preparation for market, as teams have had to rethink their approach to conducting and recording the findings from human clinical trials.

The rise of decentralized trials

One of the positive outcomes of the last 18 months has been a new surge in momentum behind decentralized or ‘virtualized’ clinical trials, harnessing the latest digital technologies. Rather than requiring patients to visit sites and clinics in person, the emphasis has been switched to improving patient experience through remote participation.

Although decentralized clinical trials have been on the radar for some time now, it has taken the pandemic to make process digitalization and associated modification to study protocols a priority.

In addition to overcoming pandemic-related restrictions to travel and close contact, this approach has created the potential for companies to engage patients from a broader geographic area. This in turn is helping with recruitment, as treatments become more targeted and specialized - making it harder to enlist patients in a timely manner.

For small, innovative biotechs with modest resources, the option to recruit and work with candidates remotely is a particularly powerful one. On top of the benefits already mentioned, they need no longer worry about the escalating costs of conducting on-site clinical trials.

Technology’s role in keeping candidates connected

Inevitably there are a number of considerations as trial activity becomes more decentralized and patient centric – around the collection of data directly from patient, the equipment that will be used, how will this be distributed, and its correct use ensured. There’s also the question of whether digital readings and remote video sessions be sufficient to build up an accurate picture of candidates’ evolving status/quality of life and health outcomes.

Whatever the practical barriers however, the potential of decentralized clinical trials is substantial and, as technology becomes ever more sophisticated, many of those issues will go away. Connected, wearable devices such as Apple Watches or digital glucometers, which feed data directly to investigators, offer one way around concerns about variances or errors in candidate behavior. And if blood work or ECG readings need to be taken, there’s always the option to report to a local clinic or lab, as the world starts to open up again – as long as there is smart integration between the systems used by those facilities and those at the trial HQ, to support seamless data exchange or reporting continuity.

Connecting the dots: a specialist SaaS-based platform

Using a secure, cloud-hosted Software as a Service (SaaS) platform – one supporting modern life sciences use cases, across clinical R&D, quality, safety and/or regulatory scenarios – offers a persuasive way forward here.

By enabling global accessibility of a single, comprehensive data set - from any location and across multiple use cases – those running clinical trials can facilitate virtual studies, without losing sight or control of the process.

A modern, API-driven SaaS platforms like Generis CARA Life Sciences allows trial operators to harness all options – either designing new trials around a virtual model or facilitating a hybrid approach in which remote trial activity supplements in-person studies.

A firm foundation for the future

What’s particularly appealing about platforms like CARA is how quickly it can be deployed, while also supporting a wider range of applications – both now and in the future. This offers companies a base from which to build and expand digital process transformation, all underpinned by the same investment and able to draw on the same data sets. Partners like Cognizant can serve as trusted advisors on this journey from vision to strategy, to planning and execution.

Certainly, decentralized clinical trials are here to stay. The last 18 months have crystalized the potential of the virtualized research model, driving a rate of deployment and progress that might otherwise have taken 5-10 years to materialize. Now that its scope has been realized and clinical trials are able to progress at the rate currently needed, there will be no going back.

Venu Mallarapu is Senior Director for Life Sciences/Global Head of R&D Solutions at Cognizant , which helps life sciences organizations around the world to accelerate innovation through end-to-end digital process transformation across pharma and medical device R&D.

Venu is responsible for taking Cognizant’s R&D service offerings to clients across the globe. He acts as a trusted advisor and strategic partner to address clients’ challenges and realize their vision and objectives. He also manages multiple strategic partnerships with leading R&D platform vendors.

Venu has over 23 years’ experience in business and IT advisory, strategic consulting, relationship, and delivery management with 15+ years of experience in Life Sciences Research & Development. He is a subject matter expert and thought leader in Clinical, Regulatory, Quality and Safety & Pharmacovigilance functions. He has delivered Strategy & Transformation Advisory Consulting to some of the world’s leading Pharma, Biotech, Vaccine, and Medical Devices organizations. He has been a prominent speaker at a range of Life Sciences and Tech industry events and is a recognized thought leader in R&D, with numerous published articles. He is also an occasional blogger through his personal “Living on the Edge” blog.

LINKEDIN: Venu Mallarapu

TWITTER: @vmallarapu


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