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Future of Clinical Research
Build vs buy: A guide on adopting AI agents for life sciences
“Big corporations can’t rely on their internal speed to match the transformation that is happening in the world. As soon as I know a competitor has decided to build something itself, I know it has lost.”
These candid sentences from Sanofi CEO, showcase one of the most common questions that’s at the forefront of every pharmaceutical company’s mind; whether to build or buy your way into the agentic and generative AI revolutions.
In life sciences, many teams start with the same instinct. They see a capable large language model, stand up a proof of concept, and feel close to a breakthrough. For most of us, AI prototypes can look magical. A chatbot summarizes visit reports, drafts emails, or answers protocol questions in minutes. The experience is so strong that teams assume production is a short step away.
Unfortunately, the gap is much bigger than it looks.
According to a recent MIT study, 95% of AI pilots will fail, as they note that “Only 5% of custom GenAI tools survive the pilot-to-production cliff, while generic chatbots hit 83% adoption for trivial tasks but stall the moment workflows demand context and customization.”
Like MIT’s example shows, moving from prototype to production in clinical research means building something validated, compliant, scalable, and integrated into real workflows. That takes far more than clever prompts. It requires domain grounding, continuous monitoring, retraining loops, robust tool orchestration, and evidence that the system is safe and auditable under regulations like GxP, HIPAA, and 21 CFR Part 11.
Many organizations only discover the hidden costs after they have committed. Internal teams often invest for two years, spend millions in sunk cost, and still never reach a dependable clinical grade system. The illusion comes from how easy it is to get an early demo working, and how hard it is to make that demo survive contact with trial reality.
Medable Petitions Comments on ICHE6(R3) Draft Guidance
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.
Unlocking Patient Engagement: Enhancing the Clinical Trial Experience with Consumerization
In this panel discussion, industry experts from Uber Health, iXlayer, and Medable will discuss the rise in technology adoption has also raised the expectations of trial participants, who now seek simpler, more consumer-like experiences in clinical design.
The Digital Future is Now eBook
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.
DCT Digital Week: Creating the Digital Foundation for Scale in Clinical Development
Learn how sponsors and CROs can improve their clinical trial conduct by developing new strategies that create sustainable, repeatable, and effective clinical conduct.
The Definitive Guide to Digital Evidence Generation
According to Grandview Research, the hybrid and decentralized clinical trial (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. Sponsors are increasingly turning to DCT platforms in alignment with the rise of Life Science and Software-as-a-Service (SaaS) solutions. For those who haven't made the jump yet, there are many questions, including "What is a decentralized clinical trial?" Find out with this in-depth guide to decentralized clinical trials. Uncover how they work, their benefits, and how they transform clinical development.
Medable joins CancerX alliance to further the Cancer Moonshot
Along with some of the best companies in the world, Medable is proud to join CancerX as a founding member. This alliance is co-hosted by the Moffitt Cancer Center and the Digital Medicine Society (DiMe), alongside the Office for the National Coordinator for Health Information Technology (ONC) and Office of the Assistant Secretary for Health (OASH).
What does the new European Medicine Regulatory Network recommendation paper on decentralized elements in clinical trials tell us?
Learn what impacts the new European Medicine Regulatory Network recommendations paper means to your clinical trial operations.
New EU Regulatory Recommendations for Decentralized Trials Keep Focus on Patients and Sites
As clinical trials rapidly modernize, government regulators work to evolve even as the same core principles apply. Still, decentralized clinical trials are – simply – clinical trials, as all research today is decentralized in some way, yet we lack global harmonization of regulations.
Back to basics: How digital and decentralized clinical trials enable trial diversity
The advancement of decentralized clinical trials (DCTs) allows patients to participate without having to travel to a trial site, removing many barriers that may have hindered people of diverse backgrounds from participating.
Back to basics: How hybrid and decentralized technologies impact each phase of the clinical research journey
Clinical trials require volunteers to assess medical products like devices, vaccines, or medications for efficacy and safety. For health equity to be achieved, it’s imperative that clinical trials include people from diverse backgrounds so as to represent the global population of patients using the products.