In this Hall of Fame feature, we check in with Meri Beckwith, Co-CEO of Lindus Health — the self-described ‘Anti-CRO’ fixing the misaligned incentives and outdated infrastructure that have kept clinical research back for decades.
From running complex rare-disease studies for hard-to-reach patients, to building cutting-edge AI and data platforms recognised by regulators like the FDA, Lindus Health is proving that clinical trials can be faster, more accessible and more reliable.
Their approach — combining virtual sites, remote monitoring and advanced data harmonisation — is helping underserved patients participate, improving recruitment and setting new industry standards. And the industry is taking notice, as attested to by partnerships with Oxford University, CDISC and ARIA.
Dive in to our exclusive interview with Meri, and don’t forget — applicants to this year’s awards receive a 50% discount to the HealthTechX 2025 Summit!
Tell us about your business in short. Can you share a specific success story or case study that demonstrates the real-world impact of your innovation?
Lindus Health is the Anti-CRO. We have taken the broken Contract Research Organisation (CRO) business model that has been the standard to run clinical trials for the last several decades, and created a new infrastructure that aligns incentives, leverages the best of technology and delivers better, faster clinical trials.
A recent example of our innovative techniques that comes to mind is a drug study for a rare disorder called ME/CFS. The study is quite complex with lots of different labs and screening assessments needed, all in a very tough-to-reach population that suffers from extreme fatigue and is rare to begin with.
We’re leveraging a combination of our in house eClinical Platform (Citrus™), virtual site, mobile logistics and remote monitor devices for sleep and hand grip testing. This has made the study far more accessible to patients in an extremely challenging population.
Tell us about your last 12 months. What have you found most exciting, and most challenging?
I think the most exciting thing is seeing how far we are advancing our internal technology to run better quality clinical trials.
Our AI and data management advances have been featured in Nature, we’ve built landmark partnerships with CDISC (who collaborate with the FDA) to set data standards and receiving a recent award from ARIA to build safer, more reliable clinical trial AI. We continue to advance our eClinical platform Citrus™ setting the bar higher for data management and trial operations.
In terms of the most challenging aspects, I think this kind of goes hand-in-hand with the most exciting components. Interestingly enough, despite regulatory encouragement of better data practices through technology, our industry is very much stuck in the past. It takes a lot of work to bring on board stakeholders across the industry to make progress in adoption of better quality, more modern data practices. However, we see very encouraging signs from regulators, like the FDA, giving the industry the push they need to continually set the bar higher for adoption.
What about the next 12 months? What excites you, and what keeps you up at night?
Similar to the above I think there will be more industry harmonisation on data standards. We hope to continue pushing our work with CDISC and FDA to help align the industry towards a much clearer, higher quality path in this regard.
Keeps me up at night? There has been a lot of chatter in the industry around shifting funding within biotech borne out of many market dynamics driven by news with FDA, grants, therapeutic area focuses, funding environment, etc. The key for us is to keep up to date with the shape of industry demand and to use our adaptability to our advantage to meet those demands.
How optimistic are you feeling about your space and its potential to have real impact? What trends are you expecting to see play out this year?
The trends we’re most excited about include the convergence of AI and clinical operations — not just as a buzzword, but as genuine operational tools that automate monitoring, enable instant biostatistics and optimise study design.
We’re also seeing regulators like the FDA pushing the industry toward modernisation and better data practices, which validates our approach. The shift toward patient-centric, decentralised trial models is accelerating, making participation more accessible to diverse populations who’ve historically been underrepresented in clinical research.
What topic or trend has flown under the radar in your opinion? What should we be talking about more?
The misalignment of incentives in the traditional CRO model is a critical issue that doesn’t get enough attention. Most CROs operate on change-order business models where delays and complications actually increase their revenue. This creates a perverse incentive structure that’s fundamentally at odds with sponsors’ needs for speed and efficiency.
We should also be talking more about the accessibility crisis in clinical trials. Many trials still require participants to travel to physical sites multiple times, creating barriers for those with mobility issues, caregiving responsibilities or limited resources. Our work with ME/CFS patients — who suffer from extreme fatigue — demonstrates how virtual and hybrid models can dramatically expand access to underserved populations. The industry needs to recognise that patient accessibility isn’t just an ethical imperative; it’s essential for recruitment success and data quality.
What impact did HealthTechX and the awards nominations have on your business? Have there been any unexpected opportunities, conversations etc. as a result?
HealthTechX and winning last year’s award helped raise our profile among potential customers and partners. We actually met one of our largest customers at the event itself!
The exposure has particularly helped us connect with other companies tackling similar challenges in adjacent spaces — from digital therapeutics companies needing clinical validation to pharma companies exploring novel trial designs. These connections have led to strategic partnerships that strengthen our ability to deliver comprehensive solutions. The validation from being recognised alongside other transformative companies has also been instrumental in our recent funding discussions and helped establish our credibility as we expand into new therapeutic areas.
How has regulation or government policy affected your work over the past year? What changes would you like to see?
Regulatory bodies, particularly the FDA, have been increasingly supportive of modernisation in clinical trials, which has been encouraging for our tech-first approach. The push for better data standards and quality has validated our investments in AI and our eClinical platform. Our recent partnerships with CDISC for setting data standards and our ARIA award for building safer clinical trial AI demonstrate how we’re working alongside regulators to elevate industry practices.
However, we’d like to see more harmonisation of regulations across different regions to facilitate global trials. The current patchwork of requirements adds unnecessary complexity and cost. We’d also advocate for clearer guidance on AI use in clinical trials — while regulators are generally supportive, more specific frameworks would help accelerate adoption of these transformative technologies across the industry.
Collaboration is key in HealthTech — what partnerships have been most valuable to you, and what kinds of collaborations are you looking for?
Our partnerships with data standards organisations like CDISC have been invaluable in ensuring our technology aligns with regulatory expectations while pushing the boundaries of what’s possible.
Our collaboration with Oxford University on research into clinical trial participation across demographic groups exemplifies how academic partnerships can translate insights into actionable improvements.
We’re actively seeking collaborations with patient advocacy groups, particularly for rare diseases where recruitment is challenging. We’re also interested in partnerships with health systems and primary care networks that can help us expand our EHR screening capabilities beyond our current 45 million records. Technology partnerships that enhance our AI capabilities and remote monitoring solutions are also a priority as we continue to build out our platform’s capabilities.
AI and automation are shaping healthcare in new ways — how do you see them impacting your area of expertise?
AI is fundamentally transforming how we approach every aspect of clinical trials. Our Citrus™ platform leverages AI for automated central monitoring, catching data anomalies in real-time that human monitors might miss for weeks. We’re using it to optimise study protocols before trials begin, predicting potential bottlenecks and suggesting design improvements based on historical data.
The future impact will be even more profound. We envision AI enabling truly adaptive trials that can modify protocols in real-time based on emerging data, dramatically reducing the time and cost of drug development.
Natural language processing is already helping us screen EHRs more efficiently for patient recruitment. However, the key is responsible implementation — which is why we’re working with ARIA on building safer, more reliable clinical trial AI that maintains data integrity while accelerating timelines.
What would you say to a new investor looking to invest into HealthTech?
Look for companies solving real operational bottlenecks, not just adding digital layers to broken processes. The HealthTech space is full of point solutions that address symptoms rather than root causes. The clinical trial landscape is ripe for disruption, but it requires companies willing to tackle the entire value chain, not just optimise individual components.
Focus on business models that align incentives correctly. Also, pay attention to companies with strong regulatory relationships and data advantages — these create defensible moats in a heavily regulated industry. The winners will be those who can demonstrate real-world impact with concrete metrics: faster recruitment, better retention, higher quality data, and ultimately, getting treatments to patients sooner.
And finally — who would you nominate for a HealthTechX Award? Who is the company to watch?
While we’re excited about many innovative companies in the space, we’d highlight those tackling systemic healthcare challenges with comprehensive solutions rather than point fixes. Companies like Dash Bio who are reinventing what is possible in pre-clincial research, or SAVA Health who have developed an innovative new wearable continuous biomarker sensor with many applications beyond just blood glucose.
Find out more about the HealthTechX Awards and apply here.