Empowering Digital Health Technologies In Decentralized And Hybrid Clinical Trials
Stefanini specializes in digital health enablement, combining advanced technology with a human-centric approach to bridge the gap between patients, healthcare providers, and research teams worldwide.
With extensive experience in supporting global clinical studies, we help organizations adopt, validate, and manage Digital Health Technologies (DHTs) — including wearables, point-of-care devices, medical devices — across decentralized and hybrid trials.
Our focus goes far beyond deployment. We support regulatory alignment, technical validation and global compliance to ensure every connected device meets the highest standards of reliability and oversight. By integrating intelligent monitoring, predictive analytics, and regulatory-grade processes, Stefanini helps sponsors, CROs, and other partners reduce risk, accelerate approvals, and maintain audit readiness across all study regions.
From device strategy and validation to logistics, our modular digital health ecosystem ensures that your clinical operations remain compliant, connected, and future-ready.
Accelerate your transformation in digital clinical research.
Business Challenges
Empowering innovation through smarter strategies and seamless solutions in healthcare.
How to provision, track, reuse and manage Digital Health Technologies hardware compliantly across global sites and participants?
How to design, validate, and document software for SaMD & connected devices per regulatory requirements?
In what ways can our end-to-end validation services enhance your product’s market readiness while ensuring regulatory compliance?
How can our end-to-end services from patient recruitment to post-study analysis help you de-risk the trial outcomes and optimize trial performance?”
How can we provide seamless and culturally sensitive multilingual support to your global patients and site personnel to streamline your international clinical trials and improve data collection and patient compliance?
How to navigate multi-regional regulatory frameworks and maintain audit readiness across all DHT lifecycle stages?
What strategies can we implement to accelerate your digital transformation journey and stay ahead in the rapidly evolving healthcare landscape?
Stefanini solves these challenges with an integrated digital health operations model.
Our Life Sciences Solutions
Global Provisioning & Logistics Management
- Ensure compliant, cross-border distribution of DHTs and connected medical devices.
Includes: import/export, customs documentation, localized labeling, IFU translation, device reuse programs, traceability systems, logistics dashboards, GDP/GSP-aligned operations.
Regulatory Enablement & Compliance
Ensure every digital health tool used in your trial is properly justified, documented, and compliant.
We manage classification, submission documentation, and economic operator mapping across jurisdictions — ensuring ethics and regulatory approvals are obtained smoothly and defensibly.
Computerized Systems Validation and Compliance
Guarantee that your digital tools are fit-for-purpose.
Stay audit-ready and compliant in a digital-first world. We specialize in validating computerized systems, qualifying IT infrastructure, ensuring data integrity, and remediating gaps in compliance. Whether it’s FDA 21 CFR Part 11 or EU Annex 11, we’ll help you navigate regulations, address deficiencies, and achieve seamless digital transformation with confidence.
End-to-End Medical Device Software Development:
Got a product idea?
We turn concepts into compliant, market-ready software. Supporting the entire lifecycle, from planning to post-launch updates, we specialize in SaMD and SiMD, ensuring compliance, validation, and alignment with FDA and CE standards. Let’s create software that’s safe, effective, and built to exceed industry expectations.
Multilingual Global Support
- +20 languages
- 7 delivery centers across the world
- Multilingual and Global Support: Providing extensive language support services, ensuring accessibility and convenience for patients and site personnel worldwide.
- Digital Health Application Vendor agnostic
Trial Retention Outsourcing (TRO) Services
- Comprehensive Service Portfolio: From patient screening / recruitment to post-study support, ensuring a seamless healthcare journey.
- Enhancing clinical trial outcomes with adaptive study coaching
Outcomes
Our diverse suite of services is designed to revolutionize clinical trials, patient experiences, and healthcare innovation — including studies enabled by Digital Health Technologies (DHTs) in decentralized and hybrid models. Here’s how we empower your success:
More Efficient Hardware & DHT Deployment
With our Global Hardware Provisioning Services, we ensure that medical devices, connected sensors, wearables, and other DHTs reach participants and trial sites worldwide — whether through traditional, hybrid, or fully decentralized delivery models.
Our multilingual support extends to every deployment, ensuring seamless setup, onboarding, and troubleshooting for patients and site personnel. This ultimately improves operational efficiency, supports remote participation, and enhances patient care.
Streamlined Compliance And Quality Assurance For DHT-Enabled Trials
Regulatory complexity — especially when introducing digital health tools into global trials — is no obstacle with our Quality and Regulatory Assurance services.
From building robust QMS/eQMS frameworks (FDA QSR, EU MDR/IVDR, ISO 13485) to managing submissions and audits for connected devices, SaMD, and remote monitoring tools, we guarantee compliance and quality across regions.
This enables you to focus on innovation and patient outcomes while we manage the regulatory and documentation ecosystem needed for DHT-driven DCT/HCT execution.
Cutting-Edge Digital Transformation For Remote Data And Systems
Our Computerized Systems Validation and Compliance services prepare you for a fully digital clinical operations landscape — including decentralized data capture and DHT workflows.
By validating digital endpoints, software integrations, eCOA/ePRO systems, and ensuring audit-ready data integrity aligned with FDA 21 CFR Part 11 and EU Annex 11, we empower organizations to embrace digital transformation with confidence.
Next-Generation Medical Device & Digital Health Software
With our End-to-End Medical Device Software Development services, we transform ideas into compliant, market-ready digital health tools.
From early concept to post-launch lifecycle management, we develop SaMD, SiMD, mobile health applications, cloud platforms, and device integrations that exceed industry standards for safety, effectiveness, cybersecurity, and regulatory alignment — ensuring readiness for decentralized and hybrid research environments.
Enhanced Patient Engagement And Retention In DCT/HCT Models
Through our Trial Retention Outsourcing (TRO) Services, we streamline every aspect of patient management — from screening and recruitment to remote coaching and post-study support.
Adaptive study coaching helps participants stay engaged with both the protocol and their digital devices, improving adherence, data completeness, and overall retention.
This holistic approach simplifies the decentralized patient journey and significantly strengthens data reliability.
Seamless Global Communication And Support For Digital Health Tools
Our Multilingual Support Services break language and technology barriers, providing assistance in more than 20 languages via seven strategically located delivery centers.
Whether supporting patients through wearable onboarding, troubleshooting sensor connectivity, or guiding sites on digital workflows, we deliver culturally sensitive and highly responsive support.
With vendor-agnostic digital health application expertise, we streamline trial operations, data management, and DHT usability — creating a truly global support framework.
Our services deliver transformative outcomes, making your healthcare initiatives seamless, compliant, and impactful.
Our services deliver transformative outcomes, making your healthcare initiatives seamless, compliant, and impactful.
Use Cases For Comprehensive Healthcare Services
01
Global Hardware Provisioning Services
A medical device company needed to supply specialized equipment to 50 trial sites across 15 countries. Leveraging our global provisioning services, they ensured timely delivery and setup of devices. Multilingual support facilitated user training, enabling sites to operate efficiently, reduce downtime, and focus on patient care.
02
Quality And Regulatory Assurance
A medtech startup faced complex regulatory hurdles for launching a new diagnostic device in the U.S. and Europe. Our team built a robust QMS framework aligned with FDA QSR and ISO 13485 standards.
03
Computerized Systems Validation And Compliance
A CRO faced compliance issues with their clinical data management systems. We validated their computerized systems and ensured compliance with FDA 21 CFR Part 11. By remediating data integrity gaps, we made them audit-ready, reducing regulatory risks and ensuring uninterrupted operations.
04
End-to-End Medical Device Software Development
A healthcare company wanted to develop a SaMD for remote patient monitoring. We handled the full lifecycle, ensuring compliance with FDA and CE standards. The product launched successfully, offering real-time patient insights and improving outcomes, while meeting regulatory requirements.
05
Trial Retention Outsourcing (TRO) Services
A global pharmaceutical company faced challenges with patient dropout during a critical oncology trial. By implementing our TRO services, including adaptive study coaching and comprehensive post-study support, the company improved patient retention by 35%. Seamless communication and personalized guidance ensured participants remained engaged, leading to reliable data collection and faster trial completion.
06
Multilingual Support Services
A multinational biotech firm struggled to manage clinical trials across diverse regions. With our multilingual support in 40+ languages and 7 global delivery centers, they streamlined communication with patients and site personnel. Our culturally sensitive approach enhanced patient compliance, reducing errors in data collection and improving trial efficiency.
Why Choose Stefanini
Global Reach. Regulatory Depth. Human-Centric Support.
- Worldwide delivery capability across major clinical markets
- Aligned with global frameworks: FDA, EMA, PMDA, NMPA, and EU MDR frameworks
- Patient, site, and sponsor experience prioritized in every service
- Scalable engagement models — Tailored engagement — per study, per region, or enterprise-level support
- 24/7 Multilingual support service desks ensuring round-the-clock readiness
Proven +30 years experience in digital health enablement and life sciences operations
Accelerate Your Digital Clinical Trials With Confidence
Stefanini helps you move from fragmented processes to a unified, compliant, and future-ready operations model. Whether you’re preparing a new decentralized study or scaling global clinical operations, our services ensure your digital health strategy is built to perform – and built to last.
Health & Life Science Success Stories
EClinical Support For Global Healthcare Company
Discover how Stefanini, a leading IT service solution provider, has been providing innovative and flexible eClinical support services to a global healthcare company, enhancing their web-based clinical trials and driving better health outcomes.
The Future Looks Digital For Life Science
The life sciences industry is experiencing a necessary digital disruption.
Life Sciences Goes Digital
Sophie For Healthcare
Testimonials
“As a Global Business Unit Director, I am constantly seeking innovative solutions that not only meet but exceed our expectations. Stefanini’s patient retention services have truly transformed the way we engage with our clinical trial participants.
Stefanini’s approach to patient retention is unparalleled. Their dedication to putting the patient first while simultaneously delivering tangible results for our business has been remarkable. The team at Stefanini understands the critical importance of maintaining patient engagement throughout the duration of clinical trials, and their expertise has proven invaluable in ensuring our trials not only meet but exceed our objectives.
The patient retention services offered by Stefanini have not only enhanced our trial outcomes but have also provided a significant return on investment for our organization. Their tailored strategies, coupled with their unwavering commitment to excellence, have consistently delivered exceptional results, making Stefanini an indispensable partner in our clinical research endeavors.
I highly recommend Stefanini’s patient retention services to any organization looking to optimize their clinical trial performance and prioritize the well-being of their participants. Their expertise, dedication, and proven track record make them the ideal partner for driving success in the ever-evolving landscape of clinical research.”
Denis Reynders – Global Business Unit Director
“As a seasoned lifescience specialist and founder of qointa, I’ve witnessed firsthand how the increasing demand for quality and regulatory compliance is reshaping the life sciences industry. The rapid growth of the Software as a Medical Device (SaMD) sector is both exciting and challenging—it’s a space that demands not only cutting-edge innovation but also a deep understanding of complex global regulations. Navigating this landscape requires a strategic approach that balances technological advancements with stringent compliance requirements.
Through our collaboration with Stefanini, we’ve been able to address these challenges head-on, delivering solutions that seamlessly blend compliance and innovation. Together, we’ve helped life sciences companies build robust quality systems, achieve regulatory approvals, and develop software that exceeds industry standards. It’s incredibly rewarding to see how our combined expertise has enabled clients to bring transformative technologies to market faster, all while maintaining the highest levels of quality and usability.
At qointa, we believe that regulatory challenges shouldn’t stifle innovation—they should fuel it. By leveraging our partnership with Stefanini, we’ve expanded our ability to offer end-to-end solutions that turn compliance into a strategic advantage. From streamlining regulatory submissions to ensuring global readiness for SaMD products, our mission is to empower clients to stay ahead in a competitive market. Together, we’re shaping the future of health tech and driving meaningful improvements in patient outcomes worldwide.”
Rudiger Mees – Regulatory Compliance & Quality Leader at qointa
Learn More About How We Can Help Your Business Grow
01
Application Services
Our services include ITSM and IT strategy, cloud-based consulting, business process support, as well as transitional and transformational strategy.
02
Digital
With our digital strategy, we provide sweeping coverage and support for all of your digital challenges, ensuring you stay ahead of the game, all the time.
03
Staffing
We provide reliable candidates with the expertise needed to fill multiple IT-related openings, either for long-term employment or short-term projects.
04
Workplace
Increase ROI and end-user productivity with made-to-order digital workplace services from Stefanini.
05
Sophie
Based on cognitive computing and artificial intelligence, Sophie can assist with tasks such as triggering workflow, auto escalation, and much more.
06
Products
Stefanini’s solutions help enterprises around the world improve collaboration and increase efficiency. Learn about our technology enabling products here.
Why Stefanini?
End-to-End Support for Transforming Life Sciences Operations
At Stefanini, we provide comprehensive support to plan, execute, and innovate across the life sciences landscape, addressing the unique challenges of a rapidly evolving industry. Our collaborative approach ensures tailored strategies that enhance operational efficiency, support global compliance, and drive meaningful patient outcomes.
Our services encompass a wide range of solutions, including patient engagement and retention strategies, multilingual support for global operations, and hardware provisioning to streamline clinical and operational processes. We also specialize in regulatory compliance, quality assurance, and the development of cutting-edge medical device software, enabling clients to navigate complexities with confidence.
With extensive experience across pharmaceuticals, biotech, medical devices, and related sectors, Stefanini combines industry expertise with advanced technologies to empower life sciences companies to achieve their goals and thrive in a competitive landscape.
