Clinical Solutions

Providing the critical path to MedTech clinical development

Development can be challenging without the right people and processes catering to the unique needs of medical devices. IQVIA MedTech offers a seasoned medical device team, therapeutic expertise, and enhanced insights to facilitate an intelligent approach to get products to patients faster.

Connected clinical development

IQVIA MedTech offers customers a team of experts in clinical operations to provide an exceptional experience for outsourcing clinical trials. In fact, we have served more than 120 MedTech customers across 52 countries in the past five years to help improve patient care.

Our quality management systems and SOPs were designed with MedTech as the foundation to streamline the overall development process.

Unlock integrated intelligence for medical devices

Through a unified approach of data-driven insights, real world data, device trial expertise, and technology, we optimize the clinical development lifecycle for accelerated routes to approval. Our method is customized based on specific customer needs to provide clinical and regulatory services on time and on budget.

THERAPEUTIC EXPERTISE

Specialized approach to MedTech development

Therapeutic expertise isn’t just important. It’s mission-critical. Because to get to the right solutions for patients, you need to know what the problems are, and what questions to ask. Our clinical development solutions for medical device companies span across 17 therapeutic centers of excellence, including Cardiovascular, Neurology, Oncology, IVD and Companion Diagnostics.

Proprietary Research Management Platform

Our capabilities are supported by a proprietary data management platform designed specifically for the unique needs of device trials. Formerly known as staicy from genae, IQVIA MedTech’s Research Management Platform enables a compliant workflow to transform data into actionable knowledge. Providing connections through managing, analyzing, correlating and integrating your clinical data.

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End-to-end regulatory support

From early concept to post-marketing, IQVIA’s dedicated MedTech team supports your product goals across the entire product lifecycle. Our team is well versed in regional regulatory requirements to help our customers realize efficient pathways to product marketing and remain in compliance.

  • Dedicated global MedTech Regulatory Affairs, Clinical, Quality & Compliance professionals
  • Deep strategic and operational experience in product development and product lifecycle challenges
  • Agile approach to assisting clients in a primary lead capacity or in an advisory role providing expert review and strategic guidance for regulatory affairs
  • Leadership team offers more than 20 years of regulatory and quality experience to deliver optimal results
  • The office in Israel is Certified to ISO 13485 and act as an In-Country Israeli Registration Holder (IRH)

Support regulatory decision with the use of RWE

Designed to increase efficiency, reduce costs and improve medical device speed to market. Prior to market entrance leverage RWE for:

  • Refining trial design
  • Characterising unmet needs
  • Refining end points
  • PMA clinical performance study – non interventional
  • Indication expansion
  • Supplementary data / historical controls / concurrent controls

Improve commercial performance & meet regulatory requirements

Designed to demonstrate real-world safety, performance & effectiveness and improve medical device value through optimum real-world evidence generation. After product launch, consider RWE for:

  • Post-market clinical follow-up
  • Post-market performance follow-up
  • Post-approval commitments/active safety surveillance
  • Post-market effectiveness evaluation
  • Longitudinal follow-ups
  • Device Registries
  • Market value messaging

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