This presentation will discuss the good, bad, and, at times, ugly characteristics of Sponsor-CRO relationships from a small company perspective. It will highlight ideas and items to consider when beginning a relationship with a Sponsor or CRO. It will include suggestions as well as methods to implement while striving toward perfecting a Sponsor-CRO relationship.

The emergence of Decentralized Trials has focused on patient options for decentralized participation.  However, DCTs also ‘CENTRALIZE’ so many functional study activities requiring sites/CROs/sponsors greater access to study metrics, clinical data, and platform capabilities to enable decentralization and data insights.  This talk explores some of the most common pitfalls in DCT approaches and how the CENTRALIZATION of DCTs requires common sense adjustments to realize the potential/vision of these approaches.

What’s the difference between a vendor and a trusted partner? How do the latest regulatory landscape trends affect these relationships? Let’s discuss how people, companies, and technologies talk to each other in the eClinical industry.

Your organization outsources centralized, remote and onsite monitoring to your CRO … how do you oversee the new monitoring process?  Who selects the KRIs? Are they the right KRIs? Are identified risks becoming actual issues? Are monitors focusing on the most important risks and issues? Are site issues being addressed?  A multi-stakeholder group has been exploring these questions. Come hear about new monitoring metrics developed by the consortium.

We’ve all heard about the importance of patient-centricity in study design and implementation, but what does that mean in practice? Starting with the patient in mind magnifies the need for partnerships. Join YPrime to discuss working together to mitigate the risks of patient drop-off and data delays, as well as Best practices - overseeing the patient experience in an outsourced world.

Outsourcing clinical trial conduct limits our ability to track study progress and inspection readiness. Data generating technology has accelerated the clinical trial conduct with new opportunities transforming resource heavy, manual processes. Focusing on consolidating dispersed data and content sources across a multi-collaborative environment, this presentation provides an overview of technologies such as AI and BI enabling a single source of truth – improving study team performance with complete study performance overview.

Communication and strong partnerships are critical to ensuring a reliable supply chain. The pandemic has tested and stretched all partnerships across the supply chain and Bayer, through its External Manufacturing LatAm lead, will shed light on how teams became more agile to ensure a reliable supply. Adequate communication pacing, the sharing of the customer´s focus and the building of trust are keys to anticipate potential problems and to keep a reliable compliant cost effective and steady supply from CMOs and third-party suppliers.

The COVID-19 pandemic has created a variety of challenges across the clinical trial conduct space, and CTM supply is one of the areas impacted. To mitigate risk of infection associated with patients receiving CTM at clinical sites and hospitals, Daiichi Sankyo developed several approaches to maintain CTM supply in close collaboration with both internal and external stakeholders.