Executing Concurrent Decentralized RCTs and RWE at Scale

Sword Health delivers AI-powered care with clinical oversight to prevent pain, support recovery, and promote whole-body health.

Since its founding in 2015, Sword Health has been committed to “doing things right”—not just delivering care, but proving its effectiveness with robust evidence. Especially at the time, digital healthcare—particularly for musculoskeletal (MSK) conditions—was met with skepticism. Many in the field believed that hands-on, in-person treatment was the only path to true clinical outcomes.

To overcome this resistance, the company embedded clinical validation into its DNA and adopted a two-track clinical validation strategy:

• Real-world evidence (RWE): prospectively collecting baseline and longitudinal outcomes to build large, well-categorized cohorts over time.
• Randomized controlled trials (RCTs): to directly compare digital care to in-person treatment.

To understand how Sword partnered with Castor to define their solution as a new standard of care, we sat down with Fernando Correia, Senior Vice President of Clinical Affairs at Sword Health.

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Overview of the Case Study

• Industry: Digital Health/Therapeutics, MedTech
• Challenge: Sword Health sought to validate digital MSK care as a new standard but faced operational bottlenecks attempting to execute rigorous, large-scale studies with rigid legacy data systems.
• Solution: The company deployed Castor’s unified platform to rapidly build and manage complex hybrid studies, enabling seamless data capture for both rigorous RCTs and large-scale real-world evidence cohorts.
• Result: The team successfully executed two concurrent RCTs and a 200,000-patient evidence strategy, resulting in 40 peer-reviewed publications and commercial coverage for 13 million lives.

The challenge: defining their solution as a new standard of care

Sword Health set out to prove that digital care for musculoskeletal (MSK) conditions could match or outperform in-person treatment. They needed to execute rigorous, large-scale RCTs to validate this, but legacy methods created immediate bottlenecks.

The team faced three hurdles:

• Protocol Complexity: The study design required precise longitudinal tracking to balance treatment arms—nuances that pen-and-paper could not support and legacy EDCs were too rigid to handle.
• Operational Burden: With a lean clinical research team, the company could not afford the long build times or specialized programming skills required by traditional, heavyweight platforms.
• Deployment Agility: The team needed a solution that could be deployed “off the shelf” to meet aggressive timelines, while still offering deep customization for their specific therapeutic logic.

“We wanted something that would work off the shelf with minimal work, but that would allow customization,” Fernando explains.

The solution: a unified, low-code platform for rapid deployment

After surveying the landscape, the company selected Castor as its clinical data platform. Castor’s usability, configurability, and robustness set it apart from systems that were costly and cumbersome.

Castor’s EDC, ePRO, and eConsent solutions provided Sword Health with:

• Rapid Configuration: Teams executed study build and UAT via a low-code interface, eliminating vendor programming delays.
• Hybrid Protocol Support: Unified data capture for both rigorous, controlled RCTs and longitudinal, high-volume Real-World Evidence cohorts.
• Enterprise Scalability: Robust performance supporting over 200,000 participants and complex, multi-site decentralized workflows.
• Site-Centric Experience: Intuitive interface reduced site training burden and ensured high compliance across distributed clinical partners.

“What drew me to Castor was the ease of use, and, and the ability to customize it easily to our setting in our clinical trial,” says Fernando. “ Ease of use, adaptability, and reliability are three things that are really crucial in all these platforms.”

The result: two pivotal RCTs and a 200,000-patient evidence engine

Sword Health utilized the Castor platform to execute two concurrent RCTs alongside massive real-world data capture. This hybrid strategy delivered:

• Unprecedented Efficiency: An internal clinical research team of just four FTEs managed the data execution required to publish 40 peer-reviewed studies, minimizing reliance on external CROs.
• Massive Scale: The team built a structured, longitudinal RWE dataset exceeding 200,000 participants.
• Commercial Impact: This rigorous, audit-ready evidence base validated the outcomes required to secure coverage for over 13 million lives.

With Castor as a trusted partner in their validation strategy, they are well positioned to not only advance digital healthcare but also help establish it as a recognized, reimbursable standard of care worldwide.

Testimonial

Fernando Correira, Chief Medical Officer at Sword Health

Castor offers a truly seamless clinical trial experience for investigators and patients. Fast development was critical for us. Castor technology was easy to use and the self-service capability allowed us to deploy a study in just a few weeks.

Create real-world evidence with Castor EDC