Digital Health and Trial Retention Outsourcing Services - Stefanini
Industry

Digital Health And Trial Retention Outsourcing Services

Stefanini specializes in digital health solutions, using advanced technologies with a human-centric approach to bridge the gap between healthcare providers and patients worldwide.  With a strong track record in clinical studies, our focus is on building connections, improving treatment adherence, and ensuring regulatory compliance for entities in the pharmaceutical, biotech, and medical device sectors, including service providers like CROs and laboratories worldwide. Stefanini is not just a service provider but a partner in transforming the healthcare paradigm to achieve optimal health outcomes and streamlined clinical processes while ensuring regulatory compliance.

Digital Health Services And Patient Retention Solutions

How can we leverage technology to enhance your patient engagement and ensure a higher adherence to the treatment plans in your clinical trials?

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?

What’s the best approach to developing compliant and user-friendly software for your next-generation medical devices?

How can we provide seamless and culturally sensitive support to your global patient base in over 20 languages?

What solutions are available for efficiently managing and provisioning medical devices and hardware to your study sites around the world?

Our Digital Health Services

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

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

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.

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

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.

We Look Forward To Working With You To Craft The Right Digital Health And Patient Retention Services For Your Business.

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