IQVIA

Join a webcast to hear what 110 colleagues of yours say about their challenges and desires around trial oversight, and learn how IQVIA is responding.

https://www.appliedclinicaltrialsonline.com/act/comprehensive-oversight

If you are a small or mid-size pharma company without a simple solution to continuously consolidate multi-source CRO data into standardized views and analytics, you are left in a bind. You need current data from vendors for actionable oversight, but often only get those insights via vendors’ monthly reports. The varying data cadence of multiple vendors means you are typically working with some data that is relatively new and other data that older by a month or more—hardly a comprehensive picture of a trial to reassure executives’ oversight concerns.

IQVIA’s 

 (CDAS) can solve this challenge and give customers easy-to-use dashboards and a real-time view of critical KPIs regardless of who is conducting individual trials. CDAS is self-service and vendor-agnostic, meaning even with multiple vendors and formats, setting up this solution to bring your portfolio data into a current, harmonized, and easy-to-report format is quite simple and cost-effective.



What are the challenges, levels of satisfaction, and desires of sponsors in terms of clinical trial portfolio oversight?

What are optimal ways to improve trial portfolio oversight?

Learn how a platform for clinical data analytics and AI/automation can benefit sponsors in their trial oversight efforts

has 25+ years’ experience in the life sciences industry, with a career spanning academic research, preclinical drug discovery, and clinical trials culminating in a focus and passion for delivering technology solutions that help bring treatments to patients faster. Wendy is currently part of the product strategy leadership team for IQVIA Clinical Data Analytics Suite (CDAS), providing both SaaS solutions for the market as well as IQVIA’s internal CRO needs. As part of the CDAS team, Wendy is responsible for strategy, product management leadership, and go-to market activities.



pursues the use of emerging technology to provide new and more efficient capabilities to enhance clinical trial management. This includes development of new design software that supports recent advancements with AI capabilities. His team has developed several micro-products and micro-services that can be plugged in and used by any SaaS solution.



Webcasts

Webinar Date/Time: Tuesday, December 12th, 2023 at 11am EST | 8am PST | 4pm GMT | 5pm CET

How to Achieve Comprehensive Oversight of Your Entire Portfolio of Clinical Trials

The pharma industry is facing an ever-increasing pressure to reduce clinical trial cycle times and complete study start-up with the utmost speed and efficiency. The IQVIA team of clinical FSP specialists will walk you through how to traverse the volatility in starting up a trial and forecasting what is required to ensure a speedy delivery and set-up.

https://www.appliedclinicaltrialsonline.com/act/team-building

The pharma industry is facing an ever-increasing pressure to reduce clinical trial cycle times and complete studies with the utmost speed and efficiency. In order to support the reduction of white space within start-up it is essential that consideration is given to planning, resourcing, technology and processes.

In this latest webinar from IQVIA FSP our team of clinical FSP specialists will walk you through how to traverse the volatility in starting up a trial and forecasting what is required to ensure a speedy delivery and set-up. We’ll highlight how the need for in-depth resource forecasting including task navigation and building the right team structure with the right skills and knowledge are imperative in study start-up.

We’ll also outline where applying co-design processes, technology, and being able to measure success add value to your outsourcing partnerships.



Providing realistic planning, consistency, and measurements by utilizing the benefits FSP of a partnership

When and where to add “co-design” and technology to enhance study start-up

Learn the importance of how to structure study start-up in an outsourced partnership that leads to great efficiency, speed, and trial development.

VP Clinical Operations – FSP Outsourcing

holds a B.Sc (Hons) in Neuroscience from the University of Sussex and a D.Phil in cell cycle research from the Medical Research Council (UK). She has been part of the clinical FSP team at IQVIA since 2016. Kelly currently manages a global FSP partnership. She led the initial transition to IQVIA from an incumbent CRO in early 2021 and again into a sole provider relationship in 2022. Prior to that, Kelly was the Regional Head of FSP for the Asia Pacific Region. She has 20 years of experience in the industry.

Prior to joining IQVIA, Kelly held roles in Alliance, Project, and Clinical Operations management. She initially started her career as a CRA in the UK and relocated to Singapore in 2009 returning to the UK in 2021.




is a strong clinical research professional with a PhD in Biology from Milan University and a Master of Business Administration from Warwick Business School. He has more than 15 years of experience in the Life Science Industry with roles in Clinical Ops, Business Development, Data and Clin Tech. Lorenzo strategically supports clinical tech solutions for Large Pharma companies and is actively involved in different clinical process and technology improvement and optimization workstreams (i.e. site payment, site interaction, start up, contract negotiation, budgeting, enrollment optimization). Lorenzo is Italian but moved to Basel, Switzerland, 4 years ago with the family.



Webinar Date/Time: Thursday, November 30th, 2023 at 3pm EST | 12pm PST | 8pm GMT | 9pm CET

Reducing Trial Cycle Times: Highlighting the Importance of Efficient Forecasting and Team Building

Join IQVIA Technologies expert, Lou Pasquale, to learn about Computer Systems Validation for AI-enabled SaaS solutions.

https://www.appliedclinicaltrialsonline.com/act/validation-considerations

Artificial Intelligence is on everyone’s mind. It impacts our daily lives in things from auto-complete/auto-correct in text messages to more nefarious uses like writing an essay or article for publication. It is also entering the world of the SaaS solutions we use in Life Sciences.

While the intelligence might be “artificial”, the validation concerns are real. AI-enabled SaaS, when working well, supercharges our Life Sciences applications. When not, things can go off the rails quickly – and not by just a little bit.

Join us as we discuss things to consider when adopting AI features in applications and how those features impact your Computer Systems Validation efforts.




How AI-enabled SaaS solutions change the conversation about Computer Systems Validation

Current approaches to SaaS validation and where they may fall short when addressing AI Validation

Data Testing Volume vs. Single-pass Validation Approaches

heads up the Client Services organization supporting IQVIA’s eTMF SaaS application and related technologies. Lou’s team performs new client implementations, provides migration and integration services, and delivers a variety of Professional and Managed Services for IQVIA’s eTMF customers. Lou has 30+ years of experience delivering software solutions and professional services to clients in Life Sciences and is a frequent speaker at industry conferences for eTMF, clinical quality, compliance, and related technologies.

Over the years, Lou’s work history includes IT consulting, systems integration, large-scale data migrations, application development, and SaaS software development and delivery. These combine to give a breadth of experiences representing the perspectives of a software vendor and a client/consumer of software services.



Webinar Date/Time: Thursday, November 9th, 2023 
Option 1: 9am EST | 6am PST | 2pm GMT | 3pm CET

Validation Considerations for AI-Enabled SaaS

Drug development processes can be enhanced utilizing modeling and simulation approaches provided by an expert modeling team. This webinar demonstrates how to properly apply modeling and simulation approaches to achieve efficiencies in your next drug development project.

https://www.appliedclinicaltrialsonline.com/act/statistical-modeling


Drug development processes become more efficient, in terms of time and cost, with the assistance of modeling and simulation approaches widely utilized and accepted in the pharmaceutical industry. In addition, they are highly supported by regulators.

This presentation provides decision makers with an overview as to “why” modeling and simulation is important in the drug development industry. Several real-world examples that address the “what” approaches and explain “how” these approaches should be conducted to enhance the drug development process will be highlighted during the webinar.



Utilizing modeling and simulation approaches to enhance drug development efficiency (eg, increase success rates and save time and money).

Wide applicability and regulator support of modeling and simulation approaches in the drug development industry.

Director, Quantitative Clinical Pharmacology

leads the PK/PD modeling team at IQVIA. He was trained as a mathematic modeling specialist, for which he holds a PhD, and has more than 10 years’ experience in PK/PD modeling field. Before he joined IQVIA in 2020, Dr Liu worked in Certara as a modeling consultant. In addition, he worked as a modeling expert for several institutes, including Melbourne Royal Children’s Hospital, University of Newcastle in Australia, Otago University in the New Zealand, and the International Atomic Energy Agency.


Webinar Date/Time: Wednesday, November 15th, 2023 at 11am EST | 8am PST | 4pm GMT | 5pm CET

How Statistical Modeling and Simulation is Supporting Drug Development

Join IQVIA experts as they explore the strategic solutions that help to dissolve the traditional barriers for the site and add accessibility to trial designs that revolutionize workflows and amplify collaborations among sponsors, sites, and patients.

https://www.appliedclinicaltrialsonline.com/act/cornerstone

We know that study enrollment, protocol complexity, and staffing pose significant challenges within the industry, especially for clinical research sites. If we continue using conventional approaches of the past, we can’t pave the way for operational success in today's modern trials.

Join IQVIA experts in a thought-provoking webinar that approaches these challenges from the clinical research site perspective. We'll delve into strategic solutions that break down the traditional barriers and add accessibility to trial designs. By doing so, you’ll reduce the burden on sites while increasing the opportunities for the right patients to participate.

Learn how strategic site support and specialty services can revolutionize your workflows and amplify collaborations among sponsors, sites, and patients. Discover the technologies and processes that will transform your partnerships and drive operational success in patient-centric trials.



 Gain insights on how to evolve trials through the digitalization of clinical research while effectively tackling site-specific barriers and concerns related to patient enrollment.

Enhancing trial accessibility and site operations:

 Uncover methods to implement digital components and models that simplify site operations, improve data quality, and streamline data collection.

Navigating regulatory and legal frameworks: 

Learn how to establish extended site collaborations that abide by data privacy laws and Good Clinical Practice (GCP) standards to achieve regulatory compliance while maintaining successful partnerships..


brings 30+ years of clinical research experience to IQVIA in roles varying from data management to post-trial access. His focus has been on compliance in clinical trials, through training and auditing. Eric has trained clinical research staff literally around the world and has audited, supported audits and inspections on an international stage as well. Currently, Eric focuses on the continued compliance of the IQVIA DCT strategy and platform.




is a Director, Patient Centric Solutions at IQVIA. She holds over 12 years of experience within the clinical research industry, specifically in site engagement &amp; enablement. Her experience supporting sites and investigators across multiple therapeutic areas, including oncology/hematology, immunology, neurology, infectious disease helps her team develop and deliver mitigations to site resourcing gaps that affect clinical trial site performance.


Webinar Date/Time: Thursday, October 12th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST     

Site Support: The Cornerstone of the Digitalization of Clinical Trials

Diversity is a critical topic in today’s clinical research landscape. In this webinar, learn how to utilize digital health technologies to improve diversity in clinical trials.

https://www.appliedclinicaltrialsonline.com/act/diversity

Diversity is a critical topic in today’s clinical research landscape. Advances in digital health technologies can help diversify clinical trial populations by enabling remote and hybrid trial conduct, simplifying data collection, and enabling data collection in new settings. However, implementing technologies in diverse populations also poses complex design and user experience challenges.

A person’s characteristics, health status, past experiences, and environment all influence the way in which they interact with digital health technologies. Study sponsors, CROs, and medical technology vendors are challenged to design solutions and services which are fit-for-purpose, intuitive, easy to use, and scalable for diverse populations. Despite this challenge, careful, flexible, and inclusive designs have the potential to drive diversity and inclusion in clinical research.



When designing trial materials, services, and technologies, the breadth and experiences of the entire target population must be considered

Good user experience design can increase the accessibility of clinical trials to new sub-populations, though this in turn increases both trial complexity and need for careful UX design.

Understand how sponsors, service providers, and technology manufacturers can design materials, technologies, and workflows for diverse populations through case studies.


Director, Strategic Solutions, Connected Devices


With the background of medicine and clinical research education, 

has more than 19 years of experience working in the CRO industry managing centralized cardiac safety operations, data management, as well as creating end-to-end solutions for using data-generated medical devices as part of the safety and efficacy endpoints for clinical trials. In the current role, Tapan works on the protocol, program digital endpoint objectives and facilitates selection of the best fit medical grade digital technology for said protocol or program. Tapan has been a speaker on multiple forums and has authored some white papers and publications related to scenarios using medical devices within clinical trials directly from a participant’s home and through participating sites.



Associate Director, User Experience, Connected Devices

As User Experience Lead in IQVIA’s Connected Devices Organization, 

is responsible for designing and delivering best-in-class experiences for those who use connected devices in clinical trials–namely study participants and sites. Ashley has held multiple academic and industry roles related to the design, delivery, and validation of digital health products. Before joining IQVIA, Ashley was the product manager for Clinical Trial Connected Devices at MSD (Merck Sharp & Dohme). She has also published over 30 peer-reviewed publications in the realm of digital health, patient engagement, and experience design. Ashley is based in Zurich, Switzerland and has received a Master’s degree in Biomedical Engineering, as well as a Ph.D. in Epidemiology.



Webinar Date/Time: Thursday, November 2nd, 2023 at 10am EDT | 7am PDT | 2pm GMT | 3pm CET    