Mastering the Logistics of Remote Visits in Global Decentralized Clinical Trials

Join us for this educational webcast geared toward clinical trial sponsors and CROs seeking practical and actionable information on how to meet the complex logistics of decentralized clinical trials. Learn from mobile research and supply chain experts with a combined 80+ years’ experience in logistics and the execution of remote trials.

Register Free: https://www.appliedclinicaltrialsonline.com/act/logistics

Event overview

Join us for this educational webcast geared toward clinical trial sponsors and CROs seeking practical and actionable information on how to meet the complex logistics of implementing successful remote nurse visits in decentralized trials.
Hear directly from innovative leaders who will share how to overcome hurdles in distributing supplies, managing samples, and coordinating compliant remote visits.

• Mobile research nursing provider PCM Trials will discuss its network of specialized mobile research nurses who expertly handle virtual visits, drug administration, and remote data capture. Learn how they adhere to regulatory requirements in decentralized settings.
• International courier QuickSTAT will outline its temperature-controlled supply chain solutions that securely deliver investigational medicinal products directly to participant homes and transport biological samples to labs while guaranteeing tracking and chain of custody across borders.
• Global clinical trial equipment supplier Woodley Trial Solutions will provide insight into the provision, delivery, and maintenance of equipment needed to carry out DCTs across multiple countries, from centrifuges and infusion systems to ECG monitoring and POCT, all of which are fully traceable and compliant with ISO, FDA, GCP and the Sunshine Act.

With more than 80 years of combined experience in logistics and the execution of complex decentralized trials, these experts will provide sponsors with actionable steps they can take to meet the logistical challenges associated with DCTs.

Key Learning Objectives

• How to achieve the logistical feats required for successful home nursing visits as part of a DCT, which include: getting the right stuff (such as IMP, supplies, medical equipment, and biological samples) to the right place (such as to a trial participant’s home or a lab) at the right time (adhering to strict time and temperature parameters) administered by the right hands (of a skilled mobile research nurse).
• How to ensure adherence to regulatory compliance, including across international borders.
• How to guarantee tracking and chain of custody.

Who Should Attend

• Sponsors
• CROs
• Clinical Operations
• Clinical Trial Logistics
• Innovation

Speakers:

Ellen Weiss
Vice President, In-Home Solutions, Decentralized Clinical Trials
PCM Trials

Ellen Weiss is an expert in connecting CROs and sponsors with right-sized hybrid and remote solutions to collect complete data. She has spoken on understanding the logistical support necessary for IMP delivery and dosing, sample collection, logistic options and best use cases. She has deep knowledge of clinical trial research nurses and the services they provide, which enables sponsors, CROs and site investigators to have confidence that alternate-site visits can be carried out with the same data quality and subject safety as on-site visits. Ellen is a member of the Healthcare Businesswomen’s Association and a volunteer for the American Society of Clinical Oncology.

Kevin Meek
Director of Supply Chain Operations
PCM Trials

Kevin Meek is Director of Supply Chain Operations at PCM Trials. Through expert facilitation, he brings together individual subject matter experts to create cross-functional teams to focus on end-to-end results. He developed these skills in the largest health payer system in the country managing dozens of partner solutions by establishing operational management processes that achieved business goals while returning a 11:1 ROI across a $80M supplier.

He leverages these experiences to enhance the value of Supply Chain Management within PCM Trials. Whether it’s clarifying company strategy, building a robust supplier network, or optimizing the final mile delivery in support of remote visits in decentralized trials, he is creating a holistic approach to solve the global challenge of Supply Chain Operations.

Mike Sweeney
Global Head of Strategy, CGT & DTP
QuickSTATF

For over three decades Mike has successfully developed and delivered customer-focused solutions in a variety of leadership and cross functional roles within global life sciences logistics. As a trusted leader, collaborator and personalized supply chain expert, he has driven innovative and effective results that benefit customers and patients alike.

Mike’s journey began at World Courier in 1992 and includes serving as Senior Director of Patient Centric Logistics. He was responsible for the development, launch, product management and ownership of direct-to-patient services across 50+ countries and assisted in creating global processes for cell and gene therapy services. Mike’s deep experience spans international operations, customer service, training, compliance, marketing, sales, project management, IT, service development and consulting in the clinical trials through commercialization arenas.

As Global Head of Strategy (CGT & DTP) at QuickSTAT since March 2023, Mike is passionate about and committed to improving patient diversity, treatment options, experiences and outcomes. Based in Philadelphia, Mike has volunteered for the Global Clinical Supplies Group (GCSG) since 2018 with focus on direct-to-patient logistics, cell and gene therapy supply chain and efforts to improve diversity, equity and inclusion.

Chris Thompson
Senior Operations Manager
Woodley Trial Solutions

Chris’ expertise and dedication in adding value to clinical trial equipment supply and additional supportive services for clinical trials is recognized and appreciated by colleagues and clients alike.

In his role as Senior Operations Manager at Woodley Trial Solutions, Chris oversees all aspects of solutions and service delivery for clients. This includes rental of laboratory equipment; point-of-care testing devices; Dexcom Continuous Glucose Monitoring (CGM) devices; high-tech connectivity products; plus ancillaries & kitting, all of which is backed up by supporting services including project management, technical support, and product training.

A Doctor of Cellular and Molecular Biology, Chris’ passion for the development of life-changing therapies and medicines with clinical research shines through. And, his determined approach to client satisfaction ensures customers’ demanding expectations are always exceeded, and that clinical trials worldwide remain on time and on budget.

Register Free: https://www.appliedclinicaltrialsonline.com/act/logistics