Virtual Clinical Trials: A Changing Landscape for the Supply Chain and Your Patient

Study protocols are increasingly complex, needing extensive data collection, and utilising complicated drug regimes. Patients can be deterred from taking part in a trial by the need for frequent travel to a clinical site for routine drug administration and simple tests. Around 30% of patients drop out before study completion, leading to data loss, and potential approval delays. Increasingly engaged patient populations need clinical teams to work with their subject groups to improve patient recruitment and retention.

The new model for home health care allowing many visits to be conducted in a patient’s home improves patient engagement, and bringing the wider medical community to them improves compliance. Patients reap the benefits of streamlining the compliant delivery of clinical trial materials direct to their homes. Using nurses to administer investigational medicinal products (IMP), take samples and record information whilst listening to patients improves both recruitment and retention in clinical trials. Samples can be processed for direct shipment to the central laboratory, allowing adjustments to be made in patients’ care plans and drug regime.

Direct to/from Patient (DTP/DFP) Services Include:

• Delivery of clinical trial materials from an investigator site, pharmacy, or depot directly to the patient’s home
• Home pickup and delivery of collected biological specimens
• Home pickup and return of unused/partially used/expired clinical trial materials for return to investigator site
• Global Home Health Care services
• The support of different DTP supply chain models through our Marken network

Great care and experience are needed to ensure understanding and application of the international regulations and local market regulations. Sites must be well-educated in the homecare options to ensure adherence to regulations from any country in which trials will take place.

In this webinar, featured speakers will explore the value of home visits in clinical trials, the benefits gained by both the patient and the sponsor, and how homecare can make a difference to patients’ ongoing participation, quality of life and comfort throughout the trial. Their experience gleaned through years of DTP delivery shows how building the two services side by side can bring practical solutions.

Key Learning Objectives

• Acquire insights into the way DTP/DFP and home health care options as part of a protocol are changing the industry and how patients experience treatment
• Explore the challenges of traditional trials and discover the value that virtual trials bring and how we can work with patients through these types of trials
• Understand which studies and conditions are best suited to this methodology and why
• Gain insights into the set-up process for a successful trial and how to avoid risk, including critical touchpoints in the supply chain and the last mile
• Learn how the pharma and clinical trial industry is embracing this shift

Speakers

Sue Lee, Director, Hexagon Supply Chain

Sue Lee, Director of Hexagon Supply Chain is a health care supply chain professional with extensive experience shipping clinical and specialty commercial drug, and clinical samples. With over 25 years of GxP process development and application, utilising risk management and logistics planning, Sue has the business experience to produce practical solutions.

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Kimberly Finn, VP Global Homecare & DTP US Services, Marken

Kimberly Finn is Vice President, Global Home Care and Direct to Patient US Services. She has extensive experience in the clinical trial industry having started her career as a CRA. Over the past 24 years, she assumed roles of increasing responsibility within clinical operations and global project management in both pharma and CRO organizations.  Kimberly’s expertise in protocol design and clinical strategy has contributed to successful on-time delivery of complex portfolios valued at greater than $300M USD and she has directly contributed to the development of six NDA approved and marketed compounds.

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Sandra Voss, Director, Direct to Patient Services, Marken

Sandra Voss joined Marken in June 2012 as Project Manager, Clinical Trial Logistics. During her time at Marken Sandra has been managing multiple global projects in Clinical Trial Distribution and supported several additional functions within Marken such as Business Development, Pricing and Quality Assurance. Sandra has taken a critical role in launching Marken’s Direct to Patient Services by developing related Standard Operating Procedures, training and certifying the Marken network as well as managing innovative projects in that area. Sandra holds a Bachelor of Arts in International Management and obtained her Master degree in Sales and Marketing at University of Applied Sciences, RheinMain. She has gained working experience in managing key accounts in the freight forwarding business (DB Schenker) as well as advertising industry (Ogilvy Brains).

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