The rise of SaaS has transformed industries, including life sciences, by enabling new possibilities. For instance, Salesforce revolutionized how organizations managed their customers and future clients with its cloud-based software, enhancing accessibility and collaboration. Similarly, Canva made graphic design tools accessible to all, empowering professionals and casual users alike.

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Our world is drowning in data. 

Humanity generates a staggering 402.74 million terabytes of information every day. From the countless videos we stream to the endless social media scrolling, our global digital footprint is growing exponentially. This data deluge is reshaping industries, influencing our lives, and posing unprecedented challenges. 

Within clinical trials, rapidly evolving technologies are enabling researchers to capture new data points as trials grow more complex. However, this poses new challenges in managing clinical trial data. 

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DCT and digital elementsare now the new normal. But what exactly does "digital" or "decentralized" mean in the context of clinical trials?

A panel of industry experts from Sanofi, Bayer, and the Clinical Trials Transformation Initiative (CTTI) recently came together to discuss the evolution of DCTs and share their experiences.

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In today's digital age, Software as a Service (SaaS) has emerged as a cornerstone of cloud computing, transforming how businesses and individuals access and utilize software applications. 

This cloud-based software deployment model has become increasingly popular due to its accessibility, cost-effectiveness, and scalability. Now, SaaS is making significant inroads in the pharmaceutical and life sciences industries, offering solutions to longstanding challenges and driving innovation.

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In Medable’s first edition of Evidence and Insights, you’ll get an in-depth look at our research investments and collaborations exploring the effects of DCTs and clinical research technology. Through strategic partnerships and continued investment, we’ve spearheaded efforts that redefine industry standards and set a new precedent for the evidentiary basis of technology’s impact on drug development.

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In June of 2022, Open AI forever changed the world’s technological landscape with the release of ChatGPT 3.5. The explosion and proliferation of AI tools have become a focal point of interest and curiosity in almost every industry, with commentators in pharma wondering how AI can improve clinical research.

In January 2024, panelists from Syneos, Obvious Ventures, Sapphire Ventures, IDEA Pharma, and GSR Ventures joined Medable’s CEO, Dr. Michelle Longmire, to discuss the purpose, potential, and power this transformative technology offers. 

Here’s what they had to say.

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It’s impossible to deny how different clinical trials look almost four years after the pandemic revolutionized clinical research. Today, the digital and decentralized tools and technologies that enabled clinical trials to carry on through the COVID-19 pandemic are present (in some form) in nearly all clinical trials, a far cry from the dynamics of 2019.

What is the path to addressing the remaining 10,000 human diseases? 

Almost two years ago, Medable CEO Michelle Longmire asked this question in a blog titled “Accelerating the path from possibility to proof in the development of new medicines.” Back then, she wrote that leveraging the most meaningful tools we had at the time would drive new synergies at the intersection of safety, science, and speed and enable a new era of drug development.

Today, our industry stands at the precipice of a new era in clinical research, marked by rapid advancements in technologies that society widely refers to as artificial intelligence and machine learning (AI and ML). While each of these technologies has existed for some time, recent advancements in their capabilities have brought them to the forefront of our industry.

In the future, AI and ML may prove to be the most important technologies of our time, as they have the potential to enable true scalability in pharma, as well as other business sectors.

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When we think about clinical trials, our minds often gravitate toward the scientific intricacies of these studies - the testing of new treatments, data analysis, and the quest for medical breakthroughs. However, it's essential to remember that behind every clinical trial, there's a patient, and often a caregiver, whose life is deeply impacted by this journey. 

So, let’s consider this: the concept of "Participation-Life Balance" and how technology can enhance the design and workflow of clinical trials while acknowledging the holistic needs of patients and caregivers to work towards achieving this. 

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When technology enters a regulated environment, early adopters often cite regulatory uncertainty as a hurdle. In fact, a 2021 Clinical Trials Transformation Initiative (CTTI) survey showed that regulatory uncertainty and lack of harmonization were the top reasons that hindered adoption of elements of decentralized clinical trials (DCTs). 

During the COVID-19 pandemic, the increased adoption of decentralized methodologies was guided by temporary guidances put out by many regulators such as FDA’s March 2020 “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency” and the corresponding EMA guidance, which explicitly mentioned it would expire at the end of the designated Public Health Emergency. 

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According to Grandview Research,the hybrid and decentralized clinicaltrial (DCT) market will be worth more than 12 billion dollars by 2030. Sparked by the COVID-19 pandemic of 2020, the rapid ascent of patient centered technology and the digital and decentralized trials they’ve spawned has forever changed the landscape of clinical conduct.