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Clinical Operations Track clear filter
Thursday, September 26
 

1:30pm EDT

OPERATIONS TRACK: Chair Opening
Thursday September 26, 2024 1:30pm - 1:45pm EDT
Speakers
avatar for Brendan Doran, PharmD

Brendan Doran, PharmD

Executive Director, Clinical Operations, CinRx Pharma
 Brendan Doran, PharmD serves as the Executive Director of Clinical Operations for CinRx Pharma and brings more than 15 years of experience in the pharmaceutical industry and clinical pharmacy practice. Dr. Doran oversees clinical operations for CinRx’s 6 therapeutically focused... Read More →
Thursday September 26, 2024 1:30pm - 1:45pm EDT

1:45pm EDT

OPERATIONS TRACK: Participant Payments
Thursday September 26, 2024 1:45pm - 2:15pm EDT
Navigating Global Challenges with Innovative Approaches

Join IQVIA Technologies to explore the intricacies of participant payments in global studies. As trials continue to grow in complexity and scale, understanding these global intricacies – including country-specific regulatory nuances – is crucial. Together, we’ll dig into the details of paying participants in several notoriously challenging countries, discuss best practices to navigate these country- specific challenges and introduce a new approach to managing participant payments.
  • Discuss the complexities of managing participant payments and in global studies.
  • Review country-specific challenges and gain insights into effective methods to manage participant payments around the world.
  • Explore a new approach to providing participant payments that addresses global complexities.
Speakers
avatar for Shaun Williams

Shaun Williams

Senior Director, Participant Payment Solutions, IQVIA Technologies
Shaun Williams leads the Clinical Trial Participant Payment Solutions business as Senior Director at IQVIA Technologies. Prior to joining IQVIA, Shaun held senior leadership positions at several life sciences companies including Syneos Health, Sitero, Premier Research, Grifols, and... Read More →
Thursday September 26, 2024 1:45pm - 2:15pm EDT
  Clinical Operations Track
  • Qtag clinicaloperationsfeaturedsession

2:15pm EDT

OPERATIONS TRACK: Panel - Trial Design Innovation
Thursday September 26, 2024 2:15pm - 3:00pm EDT
Optimize Clinical Trials Post-Pandemic Through Efficient Trial Design 
  • Explore the evolving dynamics between clinical trial sponsors and research sites, focusing on remote operations and site access challenges post-COVID-19
  • Quantify the impact of protocol complexity on patient burden and site operations
  • Leverage data-driven approaches to streamline start-up activities, lower costs, and enhance enrollment efficiencies.
  • Discuss strategies for effective collaboration and relationship building, with an emphasis on integrating site and patient perspectives in protocol design
Speakers
avatar for Brendan Doran, PharmD

Brendan Doran, PharmD

Executive Director, Clinical Operations, CinRx Pharma
 Brendan Doran, PharmD serves as the Executive Director of Clinical Operations for CinRx Pharma and brings more than 15 years of experience in the pharmaceutical industry and clinical pharmacy practice. Dr. Doran oversees clinical operations for CinRx’s 6 therapeutically focused... Read More →
avatar for Leila Cupersmith

Leila Cupersmith

Founder, CEO, and Principal Consultant, Choice ClinOps, LLC
As the owner of ChoiceClinOps, my focus is on providing expert consultation for phase 1-3 global oncology clinical trials, ensuring they are conducted with the utmost precision, from start-up to close-out. Our team excels in managing intricate operations, evaluating suppliers, and... Read More →
avatar for Victor Lucariello

Victor Lucariello

Associate Director, Study Optimization, Bristol Myers Squibb
Pharmaceutical industry professional with 20+ years’ experience in drug research, specializing in CR&D with an expertise in hematology & oncology trials for Phase I (patients) through Phase IIIb. In the past 10 years skillsets for Project Management and Process Development have... Read More →
avatar for Suzanne Parker

Suzanne Parker

Executive Director, Clinical Operations, MacroGenics
Suzanne Parker is a pharmaceutical industry professional with over 25 years of experience leading teams through the various stages of the clinical development process from study concept, enrollment, reporting and health authority submissions in major global and emerging markets. Suzanne... Read More →
Thursday September 26, 2024 2:15pm - 3:00pm EDT
  Clinical Operations Track
  • Qtag clinicaloperationsfeaturedsession

3:30pm EDT

OPERATIONS TRACK: The Quality and Compliance Compass
Thursday September 26, 2024 3:30pm - 4:00pm EDT
Leverage the Trial Master File (TMF) to Gain Valuable Insight into the Clinical Quality Compliance of Your Study 
  • Understand how missing protocol training documentation can indicate greater quality compliance issues in the study
  • Examine critical documents like site monitoring reports and oversight documentation to evaluate possible risks and compliance concerns
  • Discuss how TMF content gaps may signify data integrity issues within the study
  • Use the TMF as a strategic study asset to ensure the study’s success by proactively identifying risks

Speakers
avatar for Donna Dorozinsky

Donna Dorozinsky

Founder & CEO, Just in Time GCP
As the Founder and CEO of Just in Time GCP, my mission is to elevate clinical compliance and inspection readiness through strategic leadership and the adept use of clinical technologies. With a robust background in the field, our team excels in executing eClinical technology and GCP... Read More →
Thursday September 26, 2024 3:30pm - 4:00pm EDT
  Clinical Operations Track
  • Qtag clinicalqualityfeaturedsession

4:00pm EDT

OPERATIONS TRACK: Panel - Site Engagement
Thursday September 26, 2024 4:00pm - 4:45pm EDT
Build Deep-Rooted Relationships with Investigators and Site Teams to Increase the Innovation and Optimization of Clinical Operations 

  • Evaluate the efficiency and quality benefits from investing in effective site engagement
  • Discuss strategies for prioritizing the need for site engagement internally
  • Leverage different functional models to share resources across studies for most cost effective development
  • Identify easy action items to operationalize better site engagement

Speakers
avatar for Brendan Doran, PharmD

Brendan Doran, PharmD

Executive Director, Clinical Operations, CinRx Pharma
 Brendan Doran, PharmD serves as the Executive Director of Clinical Operations for CinRx Pharma and brings more than 15 years of experience in the pharmaceutical industry and clinical pharmacy practice. Dr. Doran oversees clinical operations for CinRx’s 6 therapeutically focused... Read More →
avatar for Shafaat Ali Khan, M.B., B.S.

Shafaat Ali Khan, M.B., B.S.

Associate Director – Investigator Engagement Clinical Research Lead (CRL), Eli Lilly
Ali is a seasoned clinical research professional with a passion for revolutionizing the way clinical trials are conducted. As the leader of Lilly's Site and Investigator Engagement organization, Ali spearheads efforts to operationalize and execute highly decentralized clinical trials... Read More →
avatar for Solomon Yakubov

Solomon Yakubov

Associate Director, Site Engagement – Global Clinical Operations, GSK
Results-driven clinical operations leader with a 10+ year career in successfully delivering clinical trials across immuno-oncology, oncology, vaccines, infectious disease, cardiovascular, respiratory, and renal + metabolic therapeutic areas. Currently serving as Associate Director... Read More →
Thursday September 26, 2024 4:00pm - 4:45pm EDT
  Clinical Operations Track
  • Qtag clinicaloperationsfeaturedsession
 
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