IQVIA

Learn how a risk-based quality management approach can ensure sponsors meet the regulatory requirements for trial oversight

https://www.appliedclinicaltrialsonline.com/act_w/sponsor-level-oversight

Oversight of a clinical trial is the regulatory responsibility of the Sponsor, but even with technological advances, data transparency can be limited with outsourced trials. So how can Sponsors meet the regulatory criteria for oversight with such limited data access?

By providing a holistic view of trial data, RBQM technology is one way that Sponsors can observe and confirm the highest quality of data while minimizing the risk of unexpected issues or delays. The resulting benefits include improving the efficiency, reliability, and effectiveness of clinical research programs.



The varied definition of oversight between Sponsors and CROs

How a risk-based quality management approach facilitates consistent and near real-time trial oversight

How RBQM technology can enable trial oversight

 brings expertise in technology training, adoption and implementation across various clinical trial platforms. She is passionate about people, process and technology and has extensive operational experience supporting study teams in the use of RBQM technology. Rachael is currently an Associate Director supporting IQVIA’s Risk Based Quality Management SaaS Solution.



is an experienced risk-based management project advisor and project lead with a strong background in clinical operations and project management. She has supported study trial teams and IT development in RBQM implementation across all phases and therapeutic areas, driving the development of processes, tools, and systems. Gayle is also experienced in assuring high-quality business performance of clinical operations within global projects.

Webcasts

Leveraging RBQM Technology to Enable Sponsor-Level Clinical Trial Oversight

Join this webinar to understand the best practices and considerations around the use of Digital Health Technologies in clinical trials.

https://www.appliedclinicaltrialsonline.com/act_w/digital-health

The event intends to discuss important aspects to be considered when planning a clinical trial with Digital Health Technologies capable of data collection from a patient’s home. Topics will revolve around the ease-of-use of devices that leads to adequate and accurate data collection practices.

Implementation of these practices has the potential to make trials less burdensome to the patient, thereby increasing retention rates. Emphasis will be on practical methods to transition from a site centric data collection model to a patient centric model and ensure the balance between the use of the latest technology while staying compliant with Good Clinical Practice.



The importance of the ease of use of devices for patients and how that enhances retention

How to plan a direct to patient’s home medical device data collection, while considering privacy implications

How to select appropriate partners and technologies for your clinical trials

Director level and above Clinical Operations and Procurement professionals at pharmaceutical and biotech companies

Director, Medical Devices Science & Technology, Strategic Solutions, Connected Devices, DSSM


IQVIA

With the background of medicine and clinical research education, 

 has more than 18 years of experience working in CRO industry managing centralized cardiac safety operations, data management, as well as creating end-to-end solutions for using data generated using medical devices as part of the safety and efficacy end points for the clinical trials.

His current focus is on selection of medical device technologies fit for purpose for the trial as well as technology integration to capture, harmonize and produce the required result. In his current role, he works in enabling decentralized clinical trials, through remote data capture i.e., capturing patients’ physiological data directly from home using medical grade device technology.




Associate Director of Project Management, Connected Devices


IQVIA

With over 12 years dedicated to preclinical and clinical trial research, Tracy has supported hundreds of trials in various capacities, including as a Quality Manager in a preclinical research facility, a cardiac safety PM running centralized studies with multiple devices, a Scientific Affairs PM, managing and reporting statistics for Cardiac Safety reports, Integrated Summaries of Safety, Reader Variability across multiple device services lines included imaging. Tracy has been with IQVIA Connected Devices for 4 years and is currently managing a small team in project management as well as supporting her key clients as a Strategic/Operations Lead.

In her current role, Tracy supports both strategic conversations around device selection as well as streamlining and developing operational processes as they bring on new devices and capabilities into the CD portfolio.

Webinar Date/Time:
Tue, May 9, 2023 11:00 AM EDT

Clinical Trials Moving From Site to Home—Lessons Learned from Digital Health Technologies

Self-Driving Clinical Trials are obviously a way off as they are often complicated and unique, much like a trip taken in a ‘self-driving’ car.

However, on the journey to this level of capability there are infrastructure, platform and process improvements that technology can bring today that allow you to build on that philosophy and ensure you are providing the fastest trials and filings that you can.

This webinar will take you on that journey. We will highlight current solutions, what it takes to continue to improve using both structured and unstructured content, and how over time you can build the plug and play tools that cover the time, efficiency and quality metrics you need to work smarter, mitigate risk, and demonstrate Good Clinical Practice (GCP)—all while saving the enterprise valuable time and money.

https://www.appliedclinicaltrialsonline.com/act_w/hidden-data

The Inflation Reduction Act has increased pressure on the pharmaceutical industry to speed more products to market—a tall order in an environment where even a single filing critical error can cause months of delays. Pharma has to work smarter, faster and more efficiently and this is where artificial intelligence (AI) can help.

During this session, attendees will learn how to avoid these delays by using AI to tap into the “hidden” information generated in a clinical trial that manual review can’t capture.

As a result, pharma can get to clinical trial close-out faster and regulatory filing with greater speed and precision than ever before, bringing more products to market at a time when they are needed most.

Why manual review is no longer sufficient or sustainable in today’s environment

How to stay ahead of the curve by positioning today’s enterprise for tomorrow’s AI solutions

How to use AI to animate hidden content in various clinical workflows, generating faster filings with higher quality

 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 through to more recent advancements with AI/ML capabilities where his team has developed several micro-products and micro-services that can be plugged in and used by any SaaS solution.

 leads marketing for the Clinical Data Analytics Suite (CDAS) for IQVIA Technologies. He is passionate about solving customer data analytics needs via easy to understand and implement SaaS solutions. Prior to joining IQVIA Technologies in November ‘22, Dimitrios led several marketing teams with other Healthcare IT companies such as GE Healthcare IT and 3M Health Information Systems.

Webinar Date/Time:
Session 1: Tuesday, April 18th, 2023 at 8am EDT | 1pm BST | 2pm CEST
Session 2: Tuesday, April 18th, 2023 at 2pm EDT | 11am PDT | 7pm BST

How to Use Hidden Data Flow to Accelerate Your Trials in an Inflation Reduction Act Environment

Join IQVIA Technologies’ expert, Darshan Patel, to learn about crowdsourcing UAT and how this process can reduce eTMF validation workloads.

https://www.appliedclinicaltrialsonline.com/act_w/etmf


Validation of eTMF features and functionalities is a requirement for electronic Trial Master Files (eTMF) per FDA CFR 21 Part 11, ICH GCP E6 (R2) and the EMA, initially for implementation and subsequently with each upgrade thereafter. As new features are introduced, the scope of work for validation for each upgrade can increase for an eTMF owner.
CrowdSource User Acceptance Testing offers an opportunity to minimize eTMF validation workloads. This presentation will demonstrate how eTMF vendors can utilize CrowdSource as a UAT model to support their clients, by driving joint cross-client UAT exercises during upgrade cycles.



Associate Director of Customer Success for eTMF

leads a team responsible for client relationships, training needs, system upgrades, and migrations. He has significant clinical experience in both CRO and sponsor settings and in several GXP environments. With more than a 5-year focus in the TMF/eTMF space, Darshan has worked across multiple therapeutic areas, including oncology, asthma, schizophrenia, and dementia. He is a frequent speaker at industry conferences focused on clinical quality and compliance.

Darshan earned a Bachelor of Science degree in Biomedical Sciences from St. George’s, University of London, and a Master of Science degree in Clinical Drug Development at Queen Mary University of London.


Webinar Date/Time: Option 1: Thursday, April 13th, 2023 at 9am EDT | 2pm BST | 3pm CEST
Option 2: Thursday, April 13th, 2023 at 2pm EDT | 11am PDT | 7pm BST

Crowdsource UAT: An Opportunity for Future Validation

Do you wish you had a better understanding of how applied data can impact decision making for trial design and planning? Learn how data and analytics combined with deep therapeutic and operational expertise can bring therapies to patients faster in this upcoming webinar.

https://www.appliedclinicaltrialsonline.com/act_w/domain-expertise

The clinical trial landscape has evolved in such a way that it’s more challenging to find sites and patients than ever before. Data and analytics combined with deep therapeutic and operational expertise can bring therapies to patients faster.

In this webinar, therapeutic and data science experts will discuss how real-world and clinical trial data inform the end-to-end clinical development strategy, such as:

Understand the types of clinical and real-world data utilized

Learn about the application of the data to the clinical trial

Discuss the analytics drive the decisions

Gain insights into how therapeutic expertise enhances the planning process

Vice President, Clinical Trial Analytics & Strategic Insights

, Vice President of Clinical Trial Analytics and Strategic Insights, has over 18 years of experience in the pharmaceutical industry. With a strong background in data analytics, Tina has been instrumental in driving data-driven decision-making and insights across various clinical trial programs.

In her current role, Tina leads a global team of five therapeutically aligned groups, supported by a Global Analytics team. Her focus is on delivering robust data-driven analytics and insights leveraging real world and clinical trial data to support clinical trial strategies – continuously driving data and analytics innovation and optimization.

Vice President, Americas Head of Therapeutic Strategy

, Vice President and Americas Head of Therapeutic Strategy at IQVIA, is a senior clinical research professional with over 17 years of experience in various leadership and operational roles in the pharmaceutical, CRO and data science industry.

Sheetal has extensive international experience from working and living in different geographies (United States, Asia Pacific and Europe) and managing clinical trials in 28+ countries across multiples functions of project management, clinical operations, data management, biostatistics, safety, medical writing and therapeutic strategy.

is the Global Lead for IQVIA’s AI for R&D Solutions. He has more than 20 years of pharmaceutical industry experience, both in consulting and industry. In addition to his experience with artificial intelligence and machine learning in R&D, Nathan’s areas of expertise also include Real World Evidence study design, statistical analysis and execution, and electronic medical record analysis.

Nathan has spent more than 10 years consulting in commercial and RWE areas centered around commercial excellence and R&D focused applications of AI/ML. In his current role, Nathan leads the consulting pillar for IQVIA’s Applied Data Science Center.

Webinar Date/Time: Thu, May 4, 2023 10:00 AM EDT


Connecting real-world data and domain expertise to enhance trial design and planning

Today, clinical trial sites and sponsors need informed consent solutions that are flexible enough to be delivered in hybrid and decentralized trials. In this webinar, we will discuss how to navigate this complex environment with a flexible, feature-rich eConsent platform can facilitate remote consent from multiple signers in different locations and help sites monitor and track the consent process in real-time throughout the study.

http://www.appliedclinicaltrialsonline.com/act_w/modern

Today, clinical trial sponsors and sites need informed consent solutions that are flexible enough to meet the demands of hybrid and decentralized models while ensuring patient-centricity and regulatory compliance. That’s why a feature-rich, compliant electronic consent (eConsent) platform that can facilitate a simplified traceable remote consent in diverse locations is critical to delivering modern clinical trials worldwide.

In this webinar, IQVIA Complete Consent leaders will share how eConsent can deliver an engaging informed consent experience while supporting diverse study protocols. We will discuss how to collect remote consent from multiple signers in different locations, while effortlessly monitoring and tracking the process throughout the trial lifecycle.

Support simple and complex study designs in hybrid consent models

Collect remote consent from multiple signers in different physical locations

Monitor and track remote consent progress in real-time


Director of Operational Effectiveness, Patient Consent

is an operations leader focused on the deployment, training, and implementation of eConsent. With over 16 years of technology, software-as-service (SaaS), and operations experience, David has spent the last six years developing and delivering electronic informed consent platforms – supporting everything from content creation, product development, project management, and process improvement. He is extremely passionate about the benefits of electronic consent, especially the transparency and patient centricity it provides. He is a subject matter expert for IQVIA Complete Consent and enjoys helping customers get the most value out of eConsent for their trials and the patients they serve.



Associate Director of Product, Patient Consent


IQVIA Technologies

With over 25 years of technology expertise, 

is passionate about designing and developing products that truly meets users’ needs while delivering innovation and strategic value. In her current role, Dana leads the IQVIA Complete Consent product team in scoping and documenting new product features, collaborating with engineers, delivery integration, and project management teams to deliver a feature-rich consent solution to customers.

Webinar Date/Time: Tuesday, March 21st, 2023 at 9am EDT | 6am PDT | 1pm GMT | 2pm CET
