Advances in monitoring technology present opportunities to track temperature in real-time. This allows sponsors the best of both worlds – the ability to significantly reduce temperature excursions, while also reducing the work required from site staff. This presentation will cover how these technologies are being applied and provide real-world metrics that illustrate the positive outcomes in clinical settings.

With decentralized clinical trials and patient centricity being accelerated in the light of the COVID-19 pandemic, there are a plethora of suppliers offering wearable, biosensors, devices, and app services. With the shift from traditional suppliers to technology vendors, how do we ensure the solution is fit for purpose, the supplier can meet sponsor expectations, and the clinical trial proceeds as per the plan?

In this session, Leslie Taylor will explore the impact of simulation technologies when optimizing multi-factorial forecasts.  She will discuss ways to reduce cost without creating unnecessary patient risk.  Leslie will also review the importance of integrated systems that facilitate real-time analysis through machine learning, reevaluation and reforecasting.

A deep dive into identifying and working with stakeholders in the lifecycle of IRT system development and beyond. Navigating challenges along the way to ensure a robust and successful study build and documentation.

Creating and maintaining a relationship with the IRT vendor is very important. In order to establish this, the sponsor should set up preferred standards and governance with the IRT vendors. Part of this is working together as a team and creating a standard that is vendor agnostic and simple. Using a governance plan and KPIs to keep track of trends and issues will help maintain quality and performance.

In this session we will discuss strategies for success, including: pre-kickoff and kickoff preparation, common challenges/pitfalls during system design, standards, configuration vs. customization pros and cons, integration implementation(s), UAT, and post go-live change management.

This presentation covers the development of a Global Resource Planning Tool to manage the Clinical Supply Project Manager resources across all clinical trial packaging projects. The tool utilizes study start/end data from Clinical Planning and is used in combination with pre-defined study metrics and project complexity data to define resource requirements and forecast staffing needs.

Clinical supplies have seen an influx of sponsors, big and small leveraging inventory management systems to manage and track inventory rather than on a study by study basis with IRT/RTSMs. Learn the benefits sponsors are realizing with this approach of planning and control of clinical supplies for programs.

Bayer will share how they created the pilot for their clinical trial sites to donate unused clinical trial supplies for humanitarian aid with the help of Kits4Life program coordinators, as well as Bayer's efforts in implementing, scaling and expanding the initiative with other partners. A panel discussion will follow with other sponsors who will share their recent pilot experiences. Come learn about the toolkit and how you can incorporate Kits4Life into your organization.

Colleagues from Sanofi, Eli Lilly and Hoffmann-La Roche will each share their current status and results from their Kits4Life pilots including 1) number & types of trials associated with their pilots 2) number of sites donating or invited to donate and 3) volume and types of donations made or anticipated during the pilot.

This presentation covers how Bayer's External Relationship Governance model adds value to the business ensuring a reliable partnership and complements the Sourcing & Procurement Functions, sharing current trends on procurement roles and the necessity to have an operational perspective in sight, with different approaches from different business necessities and how to best manage CMOs, 3PLs and Clinical Trials partners.