A well-defined business strategy for sourcing will define the business’ short- and long-term goals, identify existing gaps, and lead to a focused strategy achieving business objectives. If the need for a sourcing event is identified, the BSS serves as the RFx, capability assessment, and future governance framework. This session will provide an overview of BSS development, elements of consideration, and a case study showing the positive impact of a proactive, strategic plan.

Today's Pharma sponsors use a variety of sourcing approaches to support the execution of their development programs. Many sponsors partner with CROs under a functional service provider (FSP) model to serve as an execution arm or augment their internal teams. When considering models and the use of FSPs, there are some practical considerations and tips that can benefit both sponsors and service providers which we will aim to share and discuss.

Outsourcing strategy and vendor selection is one of the most important decisions for a Sponsor to make while setting up a clinical program. Depending on how many vendors need to be outsourced, that important decision may need to be made over a dozen times. Rare disease studies present the same challenges, but often the key vendors and stakeholders are underutilized and not appropriately resourced to support the study. Enrollment can be challenging and take several months to complete; therefore, reviewing study metrics quarterly for study completed tasks and assumptions is critical as the study progresses.      

Introducing clinical innovation into an organization as a capability and discipline can be approached in a variety of ways. This presentation will describe one approach – where clinical innovation is co-located within the clinical outsourcing function and will focus on the design, strategy and initial stages of implementation with a focus on key pieces of insight gained along the process.

Patients are at the core of our clinical research mission and our work expands beyond patient identification. Patient engagement is important to ensure participants continue to be supported in order to adhere to protocol requirements throughout their treatment. Forging relationships with scientific leaders and working together to enhance the pediatric patient experience brought novel ideas to support patient engagement and retention; allowing us to deliver on our common goal of making sure the patient remains at the center of our efforts.

What is the best way to access the 97% of patients who have never been involved in a clinical trial? A patient-first approach that maintains the trusted physician/patient relationship. Elligo Health Research® has access to known patients as well as their healthcare data and trusted physicians, and our eSolutions team, enabled by award-winning, innovative software, engages and retains patients throughout the clinical trial journey.

Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring. 

Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

Hear about Bayer's preparation for rolling out a new study start-up tool, specifically related to the Contracting & Budgeting module. Development of an ideal "wish list" for the module, sprint workshops, critically assessing processes, and garnering a new working group to champion the new way of working have all been part of the overall strategy. There will be more to share, perhaps even overcoming identified pain points. Stay tuned!

Industry-sponsored clinical trials benefit from favorable research infrastructures and streamlined study start-up processes. Currently, clinical trials worldwide face challenges regarding study start-up due to the time needed to finalize the contracting for a specific trial between the sites involved and the sponsor. This process currently in many countries is difficult and time-consuming. The talk should provide an overview of examples from different trial locations to address this problem.

While cyber risk is not new, cybersecurity language in CTAs and remote monitoring agreements is.  Security incidents can impact multiple parties, creating mutuality of risk. This session will discuss sample cybersecurity language from research institutions and pitfalls for sponsors.   Hear about lessons learned from sponsor audits of their vendor agreements for compliance with CTA cybersecurity obligations.  Common gaps make sponsor CTA obligations heavier.  Learn about contract provisions that mitigate risk.