Digital therapeutics (DTx)—evidence-based software interventions that prevent, manage, or treat diseases—are transforming healthcare. From cognitive behavioral therapy apps for depression to prescription-grade platforms managing diabetes and hypertension, these products are reshaping how patients engage with treatment. Yet, bringing a digital therapeutic to market requires far more than writing code. Companies must navigate rigorous clinical validation, regulatory requirements, real-world data collection, and patient adoption hurdles.

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This is where digital therapeutic contract research organizations (CROs) create exceptional value. By combining deep expertise in software-based interventions with the operational rigor of traditional clinical research, digital therapeutic CROs enable companies to generate the evidence, compliance, and patient engagement necessary for regulatory approval and commercial success.

What is a Digital Therapeutic CRO?

A digital therapeutic CRO is a specialized clinical research partner that focuses on the unique demands of digital health and software-as-a-medical-device (SaMD) products. Unlike traditional CROs, which are typically optimized for pharmaceuticals or medical devices, a digital therapeutic CRO blends two critical skill sets:

• Clinical rigor—expertise in trial design, data integrity, and regulatory compliance.
• Digital fluency—deep knowledge of software development lifecycles, app-based endpoints, and continuous product iteration.

This dual capability ensures that clinical studies for digital therapeutics are scientifically sound while keeping pace with the rapid evolution of digital products.

Key Benefits of a Digtal Therapeutic CRO

1. Bridging Clinical Rigor and Digital Innovation

Bringing a digital therapeutic to market requires balancing two worlds: software development and clinical research. Traditional CROs excel in the latter but often lack the specialized understanding of digital product life cycles. Digital therapeutic CROs bridge this gap. They understand that a DTx product is not a static device or drug, but a living software ecosystem with continuous updates, user-experience considerations, and integration with wearables or electronic health records. A DTx CRO can:

• Design protocols that accommodate iterative software versions while maintaining regulatory compliance.
• Incorporate real-time, app-based data collection, ensuring seamless integration of endpoints such as patient-reported outcomes and behavioral metrics.
• Align clinical design with agile development methods, reducing costly delays when new features or security updates are needed mid-trial.

This dual fluency allows DTx CROs to deliver trials that are both scientifically rigorous and responsive to the fast-moving world of software.

2. Navigating Regulatory Pathways in Digital Therapeutics

Regulatory expectations for digital therapeutics continue to evolve. Agencies such as the FDA’s Digital Health Center of Excellence and Europe’s MDR framework have established guidance for software as a medical device (SaMD), but approval pathways remain complex.

Digital therapeutic CROs specialize in these requirements. They can advise on:

• Evidence standards—including randomized controlled trial (RCT) design, real-world evidence, and digital endpoints—to satisfy regulators.
• Cybersecurity and data privacy compliance, ensuring that patient information is protected under HIPAA, GDPR, and other frameworks.
• Post-market surveillance requirements, critical for SaMD products that update frequently and must maintain compliance across versions.

Because digital therapeutics often combine medical and behavioral components, regulatory strategies must be both flexible and thorough. CROs with digital specialization help sponsors avoid missteps, ensuring that trials are structured to meet both current and emerging standards.

3. Recruiting and Retaining Patients

Recruiting and retaining the right patients is a well-known challenge in clinical research. For digital therapeutics, where participants must be comfortable with app-based interventions, targeted digital strategies are essential.

A digital therapeutic CRO leverages:

• Precision digital outreach, using social media, search engines, and electronic health record integrations to find suitable participants quickly.
• User-friendly enrollment and onboarding, simplifying the consent process through secure digital platforms.
• Engagement analytics, tracking usage patterns to proactively reduce dropouts and boost adherence.

These capabilities ensure diverse and representative trial populations and maintain strong retention—critical for generating reliable data and regulatory credibility.

4. Harnessing Real-World Data and Advanced Analytics

Digital therapeutics naturally generate large amounts of real-world data, from patient-reported outcomes to continuous biometric streams. A specialized digital therapeutic CRO has the infrastructure and expertise to transform this raw information into actionable evidence.

• Advanced data management platforms securely capture and integrate data from apps, wearables, and remote monitoring devices.
• AI-driven analytics identify trends, adherence patterns, and predictive markers that strengthen the clinical evidence package.
• Real-world evidence generation supports not only regulatory filings but also payer negotiations and market access strategies.

This deep analytical capability goes far beyond traditional CRO functions and is central to the success of digital health products.

5. Supporting Commercialization and Market Access

Launching a digital therapeutic requires more than regulatory approval; it also demands a clear path to reimbursement and broad adoption.

A digital therapeutic CRO helps companies:

• Align evidence generation with payer expectations, producing health economics and outcomes research (HEOR) that demonstrates cost-effectiveness.
• Provide insights into regional reimbursement policies and competitive landscapes.
• Support post-launch studies and real-world data collection to maintain market access and respond to evolving requirements.

By extending beyond trial execution, the right CRO becomes a long-term partner in commercial success.

6 Case Example: Accelerating Success with the Right Digital Therapeutic CRO

Consider a company developing a prescription digital therapeutic for insomnia. Working with a specialized digital therapeutic CRO, the sponsor can:

• Deploy a fully remote trial that integrates app-based screening, eConsent, and wearable sleep trackers.
• Monitor adherence through real-time dashboards and push notifications.
• Generate both clinical trial data and post-market real-world evidence to satisfy regulators and payers.

The result is a faster, more efficient path from prototype to widespread clinical adoption.

7. Selecting the Best Digital Therapeutic CRO Partner

Not all CROs are created equal. When evaluating potential partners, digital health companies should look for:

• Proven DTx experience—a track record of successful digital therapeutic or SaMD trials.
• Integrated digital platforms for electronic data capture (EDC), remote monitoring, and analytics.
• Regulatory expertise specific to software-based interventions.
• Patient-centric recruitment strategies optimized for digital engagement.
• Global reach to include diverse populations and multi-market compliance.

These criteria ensure that a chosen partner can manage every stage of the product lifecycle, from pilot studies to large-scale pivotal trials and post-market surveillance.

Conclusion

The digital health revolution demands a new kind of research partner—one that understands SaMDs and can operate at the speed of technology while maintaining the highest scientific and regulatory standards. A digital therapeutic CRO is that partner. By merging clinical rigor with digital fluency, these organizations design and run studies that not only meet evolving regulatory requirements but also generate compelling real-world evidence and support long-term commercial success.

Among the leaders in this space, Lindus Health stands out as a one-of-a-kind digital therapeutic CRO. Our team possesses deep clinical research expertise with cutting-edge digital health technologies, offering a platform designed for remote monitoring, real-time data capture, and continuous patient engagement. Our commitment to participant experience is further validated by its Fierce Biotech CRO Award for Outstanding Patient Recruitment and Retention, underscoring its ability to deliver high-quality data while minimizing dropout rates. With experience across multiple therapeutic areas and a focus on integrated digital solutions, we help sponsors accelerate product development, streamline regulatory approval, and achieve faster market access. Book a meeting with our team to get started.