download the comprehensive whitepaper</a>. </p>" /> download the comprehensive whitepaper</a>. </p>" />
Regions
MAIN/REGIONS
regions/
Regions
  1. Americas
  2. Asia & Oceania
  3. Europe
  4. Middle East & Africa
  1. Solutions
  2. Products
  3. Insights
  4. About
  5. Careers
  6. Contact Us
MAIN/search
MAIN/Solutions
Solutions/
SOLUTIONS
  • Research & Development
  • Real World Evidence
  • Commercialization
  • Integrated Global Compliance
  • Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
THERAPEUTIC AREAS

IQVIA TECHNOLOGIES

"Harness technology for a healthier world.

EXPLORE MORE
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
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
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
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
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
MAIN/Products
Products/
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
REAL WORLD PRODUCTS

CASE STUDY

"Data in a Day

LEARN MORE
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

INSTITUTE REPORT

"Global Trends in R&D 2023

READ MORE

Webinar

"Global Consumer Health Trends 2023 Webinar Series

Learn more

WHITE PAPER

"DCTs Deliver Big ROI

LEARN MORE

WHITE PAPER

"Capturing value at scale: The $4 billion RWE imperative

LEARN MORE
MAIN/About
About/
FEATURED INNOVATIONS
  • Connected Intelligence
  • AI & Machine Learning
  • Human Data Science Cloud
  • IQVIA Innovation Hub
  • Decentralized Trials
  • Genomics
WHO WE ARE
NEWS & RESOURCES

INVESTOR RELATIONS

"Visit our investor relations site for more information.

LEARN MORE
Unlock your potential to drive healthcare forward

By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.

LEARN MORE
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.

LEARN MORE
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.

LEARN MORE
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.

LEARN MORE
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.

LEARN MORE
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.

LEARN MORE
LIFE AT IQVIA

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

LEARN MORE

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/
Blog
Move from Molecule-to-Market Seamlessly with Data-Driven Strategy
Michel Denarié, Senior Principal, Regulatory Affairs and Drug Development Solutions (RADDS)
Michelle Gyzen, Senior Director, Regulatory Affairs and Drug Development Solutions (RADDS)
May 29, 2023
  • Blogs
  • Move from Molecule-to-Market Seamlessly with Data-Driven Strategy

A well-designed molecule-to-market plan starts in discovery and continues into lifecycle management. As you begin to navigate the wide and ever-evolving world of clinical development and drug regulation, you may find your team in need of guidance to help you identify the right indication to prioritize and build around. IQVIA’s Regulatory Affairs and Drug Development Solutions (RADDS) group provides multi-phase support to mitigate common roadblocks. Throughout your drug’s development cycle and beyond, RADDS provides a wide range of services, including:
  • Recommending an indication to prioritize based on scientific, commercial, and operational data.
  • Developing a target product profile and clinical development plan.
  • Engaging with the Food & Drug Administration (FDA) during pre-investigational new drug (IND) meetings and subsequent IND submission.
  • Conducting gap analysis to identify potential pitfalls.
  • Leading dossier development and submission.
  • Integrating technology to increase collaboration and transparency.

Use Proven Techniques to Design Effective Strategy

No two drugs follow identical pathways to the patients who need them. However, RADDS has established tried and true metrics that can help you assemble a path to market that aligns with your goals. RADDS helps customers move through the phases of product development, constructing action plans to answer the following questions (and more):

  • What assets and indications should we prioritize?
  • How do we build our target clinical and product profiles?
  • What gaps exist in our clinical and nonclinical plans that need to be addressed prior to our first in-human studies (FIH)?
  • How do we map out our clinical trials and what will be the associated time, cost, and risks to take us through registration?
  • When should we file our IND?
  • What special designations might our product be qualified for?

And the support doesn’t end once marketing authorization is achieved. To ensure continued safety and access for patients, RADDS provides customers with regulatory advice, market application expansion opportunities, and variation documentation.

Where Can I Learn More?

In a recent webinar hosted by RADDS team members, Michel Denarié, Senior Principal, and Michelle Gyzen, Senior Director, they illuminate how the RADDS team aids customers, breaking down the crucial steps needed at each phase of development. To learn more about the possibilities of partnering with RADDS on your drug’s journey to market, watch the on-demand webinar. To read a full summary and case study about a long-term RADDS partnership that led to cost savings and an expedited timeline, download the comprehensive whitepaper.

Related solutions

Regulatory Compliance

Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.

Integrated Global Compliance

Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.

Contact Us