Quality Considerations for Mobile Blood Draws and Specimen Collections: Supporting Decentralized Studies and Trials

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Laboratory Technology,
  • Wednesday, July 17, 2024

In this webinar, learn from experts with experience in leading mobile blood draws and specimen collections for a wide range of trials and studies.

Pharmaceutical, life sciences, research and healthcare organizations that need laboratory testing to support studies and trials are likely to instinctively consider the importance of quality programs for blood, urine and other specimen collections once they arrive at the lab for testing.

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What may be less common to consider — but plays a critical role in overall quality — is the protocol to ensure quality during each step of the process throughout specimen collection, processing, handling and transport that takes place prior to the specimen arriving at the lab.

The considerations grow for decentralized trials and studies where the collection of samples likely will not occur at clinics or hospitals. In fact, blood draws and specimen collection in a decentralized model often occur in the most convenient location possible for participants: their home.

The convenience offered by decentralized trials can boost accessibility and support adherence and retention. However, collecting specimens in a participant’s home and transporting specimens to a laboratory present complexities that should be integrated into an overall quality program.

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In this webinarthe speakers will focus on topics such as considerations around the sample type, to centrifuging and aliquoting protocols, to maintaining specimens at the appropriate temperature (refrigerated, frozen or ambient). In fact, a range of quality considerations at each step in the collection process play an important role in the overall quality management. If additional assessments, such as a personal interview or biometric measurements, will be conducted along with the blood draw or other specimen collection, the quality considerations expand.

Register for this webinar today to learn practical strategies to ensure quality management for sample collection, which is central to the laboratory testing requirements for decentralized clinical trials.

Speakers

Dr. Hope Karnes, Quest Diagnostics

Dr. Hope Karnes, MD, PhD, Medical Director, Quest Diagnostics

Dr. Hope Karnes, MD, PhD is a Medical Director at Quest Diagnostics. Her role is dedicated to leading, expanding and transforming the application of laboratory and mobile collection capabilities for health and life sciences clients.

Dr. Karnes received a Bachelor of Science degree cum laude in Biomedical Engineering from Washington University in St. Louis prior to earning her MD and PhD from the University of Kansas School of Medicine. She completed a residency in Anatomic and Clinical Pathology as well as a fellowship in Blood Banking and Transfusion Medicine at Washington University School of Medicine in St. Louis.

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Gene Stegeman, ExamOne

Gene Stegeman, Director, Mobile Services for Health & Life Sciences, ExamOne

Gene Stegeman serves as Director, Mobile Services for Health & Life Sciences at ExamOne, a Quest Diagnostics company. In his role, Gene collaborates with pharmaceutical, life sciences, research and healthcare organizations to develop mobile collection programs that will advance the partner organization’s research objectives.

Gene holds a Bachelor of Business Administration degree in accounting from Pittsburgh State University and a Master of Business Administration degree from Rockhurst University.

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Julia Larsen, Quest Diagnostics

Julia Larsen, RN, Director, Clinical Development Programs, Quest Diagnostics

Julia Larsen, RN, is a seasoned leader in laboratory program development. In her current role as Director, Clinical Development Programs at Quest Diagnostics, she leads partnerships with external researchers and laboratories throughout the Quest network to advance innovative research programs.

She collaborates extensively with all functions, including study design, collaboration agreements, national specimen collections, sample QC, tracking and biobanking, to drive quality throughout the research program process. Julia holds a Bachelor of Science degree in nursing from the University of Cincinnati.

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Who Should Attend?

This webinar will appeal to professionals in the following fields or having the following job titles:

  • Research & Development
  • Trial and study management/Trial and study design/Trial and study quality assurance
  • Clinical Operations/Operations Management
  • Project Management/Procurement for Clinical Trials
  • VP of Commercial Operations/Commercial Operations Manager/Commercialization Manager
  • Business Operations Lead/Strategic Partnerships/Business Development
  • Senior Executives in clinical development or strategy
  • Principal Investigators (PIs)

What You Will Learn

Attendees will learn about:

  • Significant applications of mobile collection to support decentralized trials and studies
  • Identifying important quality considerations — from collection and processing protocols to temperature requirements for transport — for the development of a mobile collections program for blood draws or other specimen collections
  • Additional assessments and measurements, such as interviews and biometrics, which may be integrated with mobile collection and their quality considerations

Xtalks Partner

Quest Diagnostics

When you choose Quest Diagnostics as your partner in BioPharma Services, you get more than lab testing. Access the reach, expertise, and renowned quality of Quest Diagnostics for every milestone of your program—from R&D consulting through clinical trials, companion diagnostic development, commercialization, and post-launch surveillance. Together we have the power to deliver better outcomes.

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