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™
  • IQVIA AI Assistant
  • 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
Meet the IQVIA AI Assistant

Your new expert analyst is here. Be at the forefront of data-driven decision-making with a new generative AI tool that enables you to interact with our products and solutions like never before. Get results you can trust, faster.

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/
Blog
Enabling clinical trial continuity in today’s environment
In this blog post, Rajneesh Patil, senior director, Clinical Operations, shares how critical remote monitoring is to keep clinical trials on track during the COVID-19 crisis.
Rajneesh Patil, Head of Process Design, Technology & Advanced Analytics for Risk Based Monitoring IQVIA
Jun 12, 2020
  • Blogs
  • Enabling clinical trial continuity in today’s environment

The COVID-19 pandemic has affected us in many ways – collectively and individually. As communities across the globe are ordered to shelter-in-place, clinical trials contend with the reality that site visits by patients, CRAs and site personnel have been severely restricted. We’re being challenged to adapt quickly as COVID-19 changes the scenario for developing medicines and executing trials, today and into the near future

COVID-19 has created several critical challenges for clinical trials as sites/investigators, patients and monitors become compromised in their ability to conduct trial processes:

  • Lack of clarity in which components of a trial are at risk
  • Risk for protocols, as patients cannot get to trial visit for endpoint collection
  • Limited capacity for site and CRO monitoring
  • Lack of access, as site staff are restricted in their ability to be at sites

At IQVIA, we are addressing this challenge with a responsive solution to monitor sites & patient data and to keep studies on track. Core to this solution is enabling innovative technology with advanced analytics to broaden the implementation of risk-based monitoring and central monitoring principles to the broader clinical portfolio.

The critical questions we need to ask:

  • With limited or greatly restricted access to clinical sites, what changes need to be made?
  • How can we help ensure the safety of patients, monitors (CRAs) and site personnel?
  • How can we keep current trials on track and deliver study milestones?
  • What operational modifications need to occur to conduct monitoring effectively?
    • During the pandemic
    • Post-pandemic environment

With expertise from cross-functional groups, we’ve built out approaches that, depending on protocols and desired endpoints, rapidly implement remote and risk-based monitoring principles.

Study Risk Impact Assessment

It is critical to quickly understand, prioritize, and triage which trials components are impacted by COVID-19 outbreak and determine what strategies and tactics need to be taken.

A trial-level impact assessment is performed to determine how COVID-19 disrupts country/site operations, and reviews the Regulatory Authority and Ethics Committee guidance, along with local government and health authority guidance. The review includes clinical operations plans along with study management risks to understand the overall continuity needs. It includes a multitude of patient considerations, such as safety, enrollment, dosing, assessments with retention and adherence in the study protocol. Additional items covered in the tailored trial-level COVID-19 risk plan cover data integrity, investigational product handling, site activation considerations, lab testing, change control documentation and vendor management.

Our monitoring continuity plan includes 4 key components:

  1. Patient visit enablement services, to ensure patients can complete trial requirements – remote, or via support to get the site. This may include televisits or home health support.
  2. Logistics and supply management where lab, supply chain and logistics are in place to ensure lab tests and patient drug are seamlessly managed both on-site and remotely.
  3. Site support services to provide sites with training and support services enabling the site’s ability to deliver upon trials in the current environment.
  4. Remote site monitoring and data Review where we enable key analytics solutions for risk identification and mitigation. This includes secure document exchange, CRA televisits and remote site support to progress trial activities.

This monitoring aspect is where we will focus the remainder of this piece, but with the understanding the this supports the overall alternative trial execution models with protocol modifications and regulatory considerations.

Focus on Patient Safety, Data Quality and Risk Mitigation

With extensive experience in Risk-based Monitoring (RBM) and Centralized Monitoring, we can enable remote visits and review the potential of remote source data verification (SDV) with a focus on patient safety and develop the best approach to mitigate the risk to data integrity. This is an analytics-driven approach to risk management, identifying site outliers swiftly. We enable data integrity checks and have a continuous review of safety data reporting with protocol non-compliance to mitigate risks by using our remote monitoring and engagement tools.

Adjusting Processes to Optimize Remote Monitoring

Using data, analytics, technology and by leveraging site monitoring expertise the study teams adjust monitoring levels quickly and seamlessly to ensure appropriate level of trial management support.

In working closely with our customers, we are making steady progress to navigate the challenging period of this pandemic to ensure the safety of those engaged in clinical development process. Our efforts are focused on keeping patients safe and clinical trials on track, and on continuing to provide the research environment for development of therapies needed today and in the future.

About the author

Rajneesh Patil is Senior Director, Clinical Operations at IQVIA and Head of Process Design, Technology & Advanced Analytics for Risk Based Monitoring. He is a gold medalist in Dental Surgery from India with Foundations in Public health from Australia alongside certified six sigma greenbelt with an MBA in organizational behavior.

YOU MAY ALSO BE INTERESTED IN

Blog
R&D Trends in Clinical Trials During COVID-19: Part three of a three-part series
By: Teresa Lamantia

Trial Continuity Monitoring
Blog
R&D Trends in Clinical Trials During COVID-19: a 3-Part Series
By: Teresa Lamantia

The Regulatory Considerations
Blog
Clinical Risk Management and COVID-19
By: Owen Corbin

How sponsors can adapt to evolving regulatory guidelines and continue vital research during the pandemic

You may also be interested in

White Paper
Emerging Market Expansion Strategies
Institute Report
Digital Health Trends 2024
Article
Reducing Waste with Intelligent Automation Accelerates Clinical Trial Success
Video
IQVIA Institute Year-in-Review 2024
Prev
Next
Contact Us