Clinical Solutions

Time 2022-09-30 15:42:34

Web Name: Clinical Solutions

WebSite: http://www.genae.com

ID:335073

Keywords:

Clinical,Solutions

Description:

Solutions Industry Segments MedTech

Clinical Solutions

Regions

Americas Asia & Oceania Eastern Europe Western Europe Middle East & Africa

Americas

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Americas

Argentina Brasil Canada Colombia Mexico United States

Asia & Oceania

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Asia & Oceania

Asia Pacific Australia & NZ 中国 India Japan 대한민국 Southeast Asia Sri Lanka

Eastern Europe

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Eastern Europe

Adriatic Bulgaria Czech Republic Hungary Poland Romania Russia Slovakia Turkey Ukraine

Western Europe

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Western Europe

Belgium España France Deutschland Greece Ireland Israel Italia Nederland Nordics Portugal Switzerland United Kingdom

Middle East & Africa

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Middle East & Africa

Middle East and Africa English regions search MAIN/REGIONS regions/

Regions

Americas Asia & Oceania Eastern Europe Western Europe Middle East & Africa

Americas

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Americas

Argentina Brasil Canada Colombia Mexico United States

Asia & Oceania

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Asia & Oceania

Asia Pacific Australia & NZ 中国 India Japan 대한민국 Southeast Asia Sri Lanka

Eastern Europe

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Eastern Europe

Adriatic Bulgaria Czech Republic Hungary Poland Romania Russia Slovakia Turkey Ukraine

Western Europe

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Western Europe

Belgium España France Deutschland Greece Ireland Israel Italia Nederland Nordics Portugal Switzerland United Kingdom

Middle East & Africa

Discover new insights, drive smarter decisions, and unleash new opportunities with the power of IQVIA Connected Intelligence.™

Middle East & Africa

Middle East and Africa Solutions Products Insights About Careers Contact Us MAIN/search MAIN/Solutions Solutions/

SOLUTIONS

Research & Development Real World Evidence Commercialization Integrated Global Compliance Technologies

LIFE SCIENCE SEGMENTS

Pharmaceutical Manufacturers Emerging Biopharma Consumer Health MedTech Generics

HEALTHCARE SEGMENTS

Information Partner Services Financial Institutions Public Health and Government Patient Associations Payers Providers

THERAPEUTIC AREAS

Cardiovascular Cell and Gene Therapy Central Nervous System GI & Hepatology Infectious Diseases and Vaccines Oncology Pediatrics Rare Diseases View All

Harness the power to transform clinical development

Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.

Research & Development Overview

Research & Development Quick Links

Clinical Trials Functional Services Decentralized Trials Consulting Therapeutic Expertise

Real World Evidence. Real Confidence. Real Results.

Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.

REAL WORLD EVIDENCE OVERVIEW

Real World Evidence Quick Links

Real World Data Sets Healthcare Data Transformation Study Design Platforms Evidence Networks Health Economics & Value Regulatory and Safety Genomics Real World Evidence Library

See markets more clearly. Opportunities more often.

Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.

COMMERCIALIZATION OVERVIEW

Commercialization Quick Links

COVID-19 Commercialization Launch Strategy & Management Brand Strategy & Management Pricing & Market Access Healthcare Professional Engagement Patient Engagement Promotional Strategy

Service driven. Tech-enabled. Integrated compliance.

Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety and quality.

COMPLIANCE OVERVIEW

Integrated Global Compliance Quick Links

Safety Pharmacovigilance Regulatory Compliance Quality Compliance Medical Information Commercial Compliance

Intelligence that transforms life sciences end-to-end.

When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.

TECHNOLOGIES OVERVIEW

Technology Quick Links

Orchestrated Clinical Trials Enterprise Information Management Performance Management & Insights Provider Reference Data Network Customer Engagement Safety, Regulatory, Quality Compliance Developer Partner Programs Technology Insights MAIN/Products Products/

CLINICAL PRODUCTS

Planning Suite Site Suite Patient Engagement Suite Trial Management Suite Clinical Data Analytics Suite

COMMERCIAL PRODUCTS

Information Management Launch Strategy & Management Performance Management & Insights Brand Strategy & Management Customer Engagement Pricing & Market Access

COMPLIANCE, SAFETY, REG PRODUCTS

Commercial Compliance Regulatory Compliance Quality Compliance Safety & Pharmacovigilance

REAL WORLD PRODUCTS

E360 Natural Language Processing MAIN/Insights Insights/

BLOGS, WHITE PAPERS & CASE STUDIES

Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.

DISCOVER INSIGHTS

THE IQVIA INSTITUTE

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.

SEE LATEST REPORTS

GLOBAL ONCOLOGY TRENDS 2022

"The IQVIA Institute's annual report on Global Oncology examining novel medicines, the impact of COVID-19, and long-term trends in use of cancer medicines.

READ MORE MAIN/About About/

FEATURED INNOVATIONS

Connected Intelligence AI & Machine Learning Human Data Science Cloud IQVIA Innovation Hub Decentralized Trials Genomics

WHO WE ARE

Our Story Environmental Social Governance Executive Team Code of Conduct Commitment to Public Health Diversity & Inclusion

NEWS & RESOURCES

News Events & Webinars COVID-19 Resources Privacy Our Locations

INVESTOR RELATIONS

"Visit our investor relations site for more information.

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Opportunity is out there, everywhere

Connecting unparalleled data, advanced analytics, innovative technologies, and deep healthcare and scientific expertise makes it possible for our customers to discover previously unseen insights, smarter decision-making, and unleash new opportunities.

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AI & Machine Learning with a healthcare IQ.

Artificial intelligence is accelerating opportunities. Realizing the benefits for healthcare requires the right expertise. Together, we can solve the problems of today, and drive the breakthroughs of tomorrow.

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Your healthcare data deserves more than just a cloud.

The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.

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Innovations make an impact when bold ideas meet powerful partnerships

The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.

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Proven, faster DCT solutions

IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.

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Unlock the power of genomic research.

IQVIA enables genomic research via global access to a network of genomic-clinical data, proprietary technologies that enable federated analytics, and therapeutic area & bioinformatics expertise to help you answer your most pressing research questions.

LEARN MORE MAIN/Careers Careers/

WORKING AT IQVIA

Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.

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LIFE AT IQVIA

Careers, culture and everything in between. Find out what’s going on right here, right now.

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WE’RE HIRING

"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.

SEARCH JOBS MAIN/Contact Us Contact Us/

Solutions Industry Segments MedTech 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.

CONNECT WITH US

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.

GLOBAL PERSPECTIVE

Grounded in medical device and diagnostic regulatory knowledge and regional trial experience, we can provide global reach to support your product ambitions.

COMPREHENSIVE EXPERTISE

Distinguished by our therapeutic and device expertise, we facilitate a connected approach for trial design and patient recruitment.

STRATEGIC CONSULTING

Comprised of seasoned MedTech industry professionals, we provide regulatory and clinical support to deliver guidance from strategic planning through lifecycle maintenance.

NOVEL APPLICATIONS

Unparalleled real world data sources provide our customers access to advanced scientific methodologies.

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.

Comprehensive and flexible EDC system

Hosted on Microsoft Azure, collects, stores and preserves health data in accordance with applicable local and global privacy regulations.

Patented geo-storage

Physically store your data where needed and abides with current data and privacy regulations.

Personalized dashboards

Powered by an integration with Microsoft’s Power BI that delivers insights by monitoring customers’ most critical business data and creating rich interactive reports.

Connected data silos, eClinical systems, and wearables

Integrate various internal and external data sources to seamlessly exchange information and simplify the data capture and review process.

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) OVERVIEW PRE-APPROVAL POST-APPROVAL

Use of Real World Evidence Across Product Lifecycle

As a proven MedTech partner with trusted expertise, we help our customers generate the right real world evidence (RWE) to meet stakeholder needs with confidence. Our novel applications of RWE are underpinned by our deep therapeutic expertise, scientific rigor and operational excellence. Alongside our global and local regulatory and payer expertise, unparalleled data assets, best-in-class technology enabled analytics and the flexibility and infrastructure to meet customer needs across the product lifecycle

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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 Learn More

Learn More Fact Sheet Understanding the Summary of Technical Documentation (STED) Learn More Blog Understanding the promising opportunities for in-vitro diagnostics companies in the next decade Learn More Fact Sheet Successfully Conducting Your Digital Health Studies Using Real World Evidence Learn More Case Study Complex Workflow and Data Collection through IQVIA Research Management Platform Learn More White Paper Usability Studies: Evaluating the Human Factor in Cardiovascular Device Usage Learn More White Paper Conducting Effective Post-Market Safety Studies for Medical Devices Learn More Webinar Understanding Regulations in China, Japan and India for Device Expansion and Clinical Operations Excellence Learn More Video MedTech Clinical Solutions Across the Product Lifecycle Learn More White Paper Leveraging Regulatory Expertise to Optimize your Design Investment Learn More Related Solutions Compliance Solutions

Quality, regulatory, safety and compliance solutions across the device lifecycle.

Commercial Solutions

Connected commercial solutions, maximizing market performance.

MedTech Technology

Technology-driven solutions tailored for MedTech.

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Get in touch today to discover the right solutions for you.

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Call Us

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