What has COVID-19 taught us about the need for unified, cloud-based technology?

As a group of academics, private industry, researchers, government and other public institutions, our collective response to COVID-19 demonstrates the need for a unified, cloud-based technology platform.

I had the pleasure of presenting a webinar alongside my colleague, Michael McGloughlin with the Emerging Biopharma division of Oracle Health Sciences, on the “Future of Clinical Trials: Reimagining the Way Technology and Data Support Clinical Research.”

We conducted a quick poll and learned that the majority of webinar attendees (63%) are managing up to five different technology platforms in support of clinical trials. I suspect that if we took into account the number of different vendors we work with who provide these technology types – such as electronic data capture (EDC) systems, electronic case report forms (eCRFs), interactive response technology (IRT), safety database providers, etc. — that number would grow exponentially.

LindsayReklis_800w

Lindsay Reklis

Associate Director, Data Solutions and Analytics, FHI Clinical

Lindsay is a clinical research professional with over 16 years of experience in biotechnology, with demonstrated expertise in clinical project management, clinical operations, data management and vendor management. At FHI Clinical, she coordinates cross-functional teams in support of clinical development programs for small- to mid-sized pharmas and large CROs.

Percentage of respondents
Number of different technology platforms each organization is managing in support of clinical trials
As our poll results showed, we were already managing multiple technology platforms before the pandemic. Now, the COVID-19 landscape has given us, collectively, the chance to try new things, take new risks and consider alternative strategies. We have been pushed to consider if and how our existing processes and systems can meet the challenges of a pandemic. We’ve experienced extreme pressure from our study sponsors on project timelines and budgets, and timelines once considered impossible to meet are now becoming the expectation for a COVID-related study.
At FHI Clinical, we’ve managed to achieve study start-up milestones within timelines we didn’t think were feasible. We’ve stretched ourselves to make the impossible a reality in terms of speed and innovation by changing processes and eliminating any steps considered non-essential. For example, in one study, the FHI Clinical team was able to activate several global sites in two weeks or less. In another study, our project team programmed the EDC database in roughly one week.
With COVID-19 putting seemingly impossible constraints on development timelines and pushing budgets to be maximized more than ever before, we’ve also seen less emphasis on scrubbing every data point and line item and more focus on quality and speed.
COVID has pushed our industry to a crossroads in terms of tools and technologies required to support clinical research. We have been forced to rethink our risk profiles while looking inward for even more innovations, technologies and processes to support virtual patient visits and the like.
Moving forward, I think we’ll continue to see further investments in, and risks taken on, new technology the industry has historically shied away from, such as telemedicine. I foresee a dramatic acceleration in adopting centralized risk-based monitoring and any technology that supports that strategy. We are likely to see further expansion into wearable technologies, remote e-consenting and clinical trial databases interfacing directly with electronic medical records.
The industry’s response to outbreaks like COVID-19 will continue to push advances in technology and influence the way we conduct clinical research. Challenges we’ve faced trying to adhere to impossible timelines and budgets have solidified the need for a technology platform that includes three main characteristics:
  • Icon_o Unified: A unified technology platform that provides a single source of data entry, sharing and reporting for all modular functions across a clinical trial lifecycle.
  • Icon_o Modular: A modular platform that allows you to focus on one, some or all modules needed to do your job. With controlled access and targeted training, modular access and training can be assigned by roles and responsibilities.
  • Icon_o Cloud-based: Provide your remote workforce global access and mobility with a cloud-based system, with minimal IT infrastructure required for implementation and support.

As my colleague Michael discussed during the webinar, it’s time for us as an industry to think and act differently. I encourage you to listen to our on-demand webinar to learn more about the benefits of a unified, modular, cloud-based platform like Oracle Clinical One. This new model presents a major shift, allowing you to think differently, streamline workflows and reallocate resources. With Clinical One, you stand to speed up the process of innovation and quickly adapt those advances into your current processes.

Want to learn more? View the on-demand webinar.

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