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
  • Safety & Regulatory Compliance
  • Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
THERAPEUTIC AREAS

Impacting People's Lives

"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.

LEARN 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, regulatory, quality and medical information.

COMPLIANCE OVERVIEW
Safety & Regulatory 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

"Digital Health Trends 2024 - Implications for Research and Patient Care

READ MORE

EMEA Insights

"IQVIA thought leadership with a focus on EMEA.

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
  • IQVIA Connected Intelligence™
  • IQVIA Healthcare-grade AI™
  • Human Data Science Cloud
  • IQVIA Innovation Hub
  • Decentralized Trials
  • Patient Experience Solutions with Apple devices
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
IQVIA AI is Healthcare-grade AI

Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.

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
IQVIA Patient Experience Solutions with Apple devices

Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.

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/
Institute Report
Lesson Learned from COVID-19 Vaccine Trials
A CRO perspective on accelerating clinical development
Apr 28, 2022
To download files you must give consent to process your personal data by clicking the "Accept" button below.

Web Summary

The COVID-19 viral pandemic has led to more than 500 million infections and 6.2 million deaths worldwide by mid-April 2022 and has been one of the top three causes of death in the United States since March 2020. The unprecedented modern-day global need for rapid development of effective vaccine and therapeutic solutions was met by a massive and coordinated response across critical health system stakeholders and led to the development of COVID-19 vaccines in well under a year — timelines previously unheard of in vaccine clinical development.

The research behind this report explores model changes that allowed for clinical trial efficiencies from the perspective of the CRO and is based on a set of workshops with COVID-19 vaccine clinical delivery teams. Our emphasis is on understanding what was possible because of the drastic operating environment changes and assessing what can be carried forward into the post-pandemic clinical development pipeline of therapies for other illnesses.

Key findings

  • COVID-19 vaccines were available for public use in seven months from the start of clinical trials in a record-breaking, cross-stakeholder response to the urgent, unmet need driven by rapidly spreading unchecked viral infections.
  • Environmental enablers, including more than $20Bn in public-private funding, regulatory authority focus, and historic investigator and subject interest in trial participation were critical in delivering these vaccines, thanks to a shifted risk-return balance.
  • A CRO explicit analysis of the operational drivers of trial-specific time savings showed pivotal trials led to an EUA filing with a 26-month, or 70%, savings versus historic trials as a result of operational improvements, organizational responses, and clinical development model improvements.
  • Process improvements driven by innovation and resource focus in contracting, start-up, recruiting and database lock were supported by intensive team, governance, and leadership focus. All of the operational and organizational changes could be tracked back to a blended shift in process redesign, resource utilization, decision-making practices, and partnership behaviors.
  • ROI analysis highlights a set of changes that are high efficiencies with potential to drive value going forward if implemented beyond vaccine trials, and a second set that is more investment intensive, but includes important drivers of speed for consideration on larger scale or highly time-sensitive trials.

Other Findings

  • Focus on individual COVID-19 vaccine pivotal trial (Phase II and Phase III) timelines to better understand operational time savings revealed that each stage of trial execution, including contracting, study start-up, enrollment, treatment, and database lock and analysis had pandemic-era specific challenges and opportunities to streamline delivery of clinically proven COVID-19 vaccines.
  • Characterization of how the COVID-19 vaccine trial level changes were achieved surfaced more than 20 critical and impactful changes that can be organized into a nested framework of operational actions, organizational alignment, and model drivers.
  • Operational actions were the specific process innovations, streamlining and shifts in resource utilization that led to in-trial efficiencies; these actions were spread across the trial process and included more than 12 critical changes.
  • Organizational alignment includes implementation of focused organizational constructs including optimized leadership-engagement, sponsor and CRO governance, team working structures, and quality and process management mechanisms to best support operational changes.
  • Model drivers include fundamental behavioral, structural, and strategic business foundations such as partnerships, decision-making processes, process innovation, and resource optimization that were shifted in the context of the pandemic and allowed for all the cross-trial organizational and operational changes.
  • Analysis of these change drivers in the context of pipeline composition can help guide ongoing change implementation to situations likely to yield positive ROI, with most being applicable to large scale, acute-care trials, and some of the higher efficiency changes likely to drive value in specialty care trials.

Institute Reports

Trends in Global Adult Vaccination

This research brief from the IQVIA Institute – Trends in Global Adult Vaccination: Impact of COVID-19 – aims to provide a baseline of adult vaccination trends and missed vaccination doses during the COVID-19 pandemic while assessing variations by countries and regions.

learn more

Blog

IQVIA Institute Research Highlights 2022

The Quest for Evidence-Based Research in Healthcare Decision-making.

learn more

Related solutions

Clinical Trials

Change the model of clinical research by integrating data, expertise, analytics and technology from study design through execution to power better decisions.

Clinical Research & Development Solutions

Explore our end-to-end, full service clinical development capabilities including Therapeutics expertise, Development Planning, Phase I early clinical development, Phase IIb/III and Phase IV Trials, Regulatory Submission and Post-Launch Studies.

Contact Us