Unlocking The Power Of Digital Health For Life Sciences Innovation
The life sciences industry is undergoing a transformative shift, driven by advancements in digital health, personalized medicine, and the rapid growth of Software as a Medical Device (SaMD). These innovations present unprecedented opportunities to improve patient outcomes, streamline clinical trials, and revolutionize how healthcare is delivered. However, they also bring unique challenges, from navigating complex regulatory landscapes to ensuring data security and global accessibility. To remain competitive and meet evolving patient and provider demands, life sciences companies must adopt new technologies, business models, and strategies.
With solutions powered by artificial intelligence, predictive analytics, cloud computing, and advanced regulatory expertise, Stefanini empowers life sciences organizations to embrace digital transformation. From pharmaceutical companies and biotech innovators to CROs, medical device manufacturers, and laboratories, our proven track record of success helps clients navigate industry complexities while driving meaningful innovation and compliance excellence.
Business Challenges
Empowering innovation through smarter strategies and seamless solutions in healthcare.
What solutions are available for efficiently managing and provisioning medical devices and hardware to your study sites around the world?
What’s the best approach to developing compliant and user-friendly software for your next-generation medical devices?
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 patient streamline your international clinical trials and improve data collection and patient compliance?”?
What strategies can we implement to accelerate your digital transformation journey and stay ahead in the rapidly evolving healthcare landscape?
How can we navigate the complex regulatory environment to ensure compliance while speeding up the market launch of our new medical products?
Our Life Sciences Solutions
Global Hardware Provisioning Services
- Providing multilingual support and supplying a wide range of medical devices, ensuring global reach and accessibility.
Quality and Regulatory Assurance
Let us simplify compliance and ensure your success. From building robust QMS/eQMS frameworks (FDA QSR, EU MDR/IVDR, ISO 13485) and ensuring data privacy compliance to handling pre-market submissions (FDA 510(k) and CE Marking), we take care of it all. We’ll manage design validation, CAPA, post-market surveillance, and audits so you can focus on innovation while we ensure top-notch quality and regulatory readiness.
Computerized Systems Validation and Compliance
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 Support Services
- +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. Here’s how we empower your success:
More Efficient Hardware Deployment
With our Global Hardware Provisioning Services, we ensure medical devices and equipment reach trial sites worldwide. Our multilingual support extends to these deployments, ensuring seamless setup and operations, ultimately improving site efficiency and patient care.
Streamlined Compliance And Quality Assurance
Regulatory complexity 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 pre-market submissions and audits, we guarantee compliance and quality. This enables you to focus on innovation while we handle the details.
Cutting-Edge Digital Transformation
Our Computerized Systems Validation and Compliance services prepare you for a digital-first world, addressing FDA 21 CFR Part 11 and EU Annex 11 compliance. By validating systems and ensuring data integrity, we empower organizations to embrace digital transformation confidently.
Next-Generation Medical Device Software
With End-to-End Medical Device Software Development, we transform ideas into compliant, market-ready software. From concept to post-launch, we develop SaMD and SiMD solutions that exceed industry standards, ensuring safety, effectiveness, and innovation.
Enhanced Patient Engagement And Retention
With End-to-End Medical Device Software Development, we transform ideas into compliant, market-ready software. From concept to post-launch, we develop SaMD and SiMD solutions that exceed industry standards, ensuring safety, effectiveness, and innovation.
Seamless Global Communication
Our Multilingual Support Services break language barriers, providing support in over 20 languages via seven strategically located delivery centers. Whether assisting patients or site personnel, we ensure cultural sensitivity and convenience. With vendor-agnostic digital health applications, we further simplify trial operations and data management, creating a truly global framework.
Our services deliver transformative outcomes, making your healthcare initiatives seamless, compliant, and impactful.
Let’s shape the future of healthcare together.
- Higher Patient Retention
- Faster Approvals
- Better Audit Success
- Better Adherence
- Accelerated Timelines
- Fewer Data Discrepancies
- Increased Efficiency
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.
Trial Performance Enhancement Services Value Proposition
Utilizing Stefanini’s services leads to a range of positive outcomes for healthcare organizations, including stronger patient relationships, improved adherence to treatment and study protocols, and enhanced health outcomes. Our strategic focus on reducing operational costs and optimizing resource utilization also ensures that healthcare providers can maximize patient satisfaction and retention, ultimately leading to more successful healthcare interventions and clinical trials.
The adoption of Stefanini’s digital health solutions translates into tangible benefits for healthcare organizations:
- Enhanced patient engagement and satisfaction, leading to higher adherence rates and better health outcomes.
- Streamlined operations and reduced costs, optimizing the use of resources and maximizing efficiency.
- Improved success rates in clinical trials through sophisticated data analytics and patient management strategies.
- A robust framework for regulatory compliance, ensuring that innovations meet global standards.
Clinical Transformation
Unlock innovation and compliance with our tailored end-to-end medical device software development, cutting-edge digital transformation, FDA/MDR compliant software validation, and patient-centric solutions for better healthcare outcomes.
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.
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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.
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Workplace
Increase ROI and end-user productivity with made-to-order digital workplace services from Stefanini.
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Sophie
Based on cognitive computing and artificial intelligence, Sophie can assist with tasks such as triggering workflow, auto escalation, and much more.
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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.
