As clinical trials become increasingly outsourced and complex, regulatory authorities like the EMA and FDA are placing growing emphasis on how Marketing Authorization Holders (MAHs) have oversight on their third-party vendors. Robust vendor oversight is not only a regulatory expectation—it’s a key component of inspection readiness, risk mitigation, and overall trial success.

With experience across CROs, pharma, and numerous small biotechs, Arielle Valette shares practical strategies for selecting and managing vendors to align with scientific goals and ensure trial quality. Drawing on her leadership in vaccines and immune therapies, she offers insights on optimising oversight, driving accountability, and maintaining compliance—empowering small to mid-sized biopharma teams to build effective, scalable partnerships in today’s complex clinical trial landscape.

For emerging and mid-sized biopharma companies, selecting the right clinical trial vendors is critical to trial success. This session will outline practical strategies for identifying, evaluating, and overseeing vendors with an emphasis on compliance, performance, and risk management. Jordi Ferra Canet, MSc, Clinical Program Manager at Laminar Pharma, shares real-world insights and best practices to help clinical operations leaders make informed, scalable vendor decisions in a resource-constrained environment.

The data demands of modern clinical trials are greater and more complex than ever, creating challenges for organisations of every size. Drawing on Big Pharma experience, I’ll share strategic principles for collecting, managing, and leveraging clinical data. Discover how FAIR data, standardisation, and risk-based focus drive value and lay the groundwork for innovation in scalable clinical data systems.

For small to mid-size biotechs, clinical trial success depends on more than selecting the right CRO—it requires a strong, collaborative partnership grounded in trust and transparency. This session presents a real-world case study of a successful CRO–biotech collaboration, showing how both teams aligned on key milestones, navigated complex challenges, and used data and analytics to drive performance. Attendees will walk away with practical strategies for vendor oversight, resource optimization, and ensuring end-to-end data visibility—critical to scaling operations with speed and quality.

Revision 3 of ICH E6 “Good Clinical Practice” places the focus on demonstrating sponsor oversight and decision-making for the outsourced activities in clinical trials. My presentation outlines a trend-setting approach to management and oversight of vendors based on the identified Critical to Quality Factors (CtQFs), Critical Processes and Data. Risk management and centralised monitoring augment evaluation of vendor performance and allow to spot the issues earlier.

Manual study start-up slows progress—especially for resource-constrained biopharmas. The Digital Data Flow initiative introduces automation and the Unified Study Definitions Model, enabling digitized protocols that streamline processes and reduce effort. Discover how these innovations help smaller organizations speed timelines, improve consistency, and deliver new therapies to patients faster.

This session provides a practical guide to launching a privacy program for clinical trials, focused on three priorities: ensuring transparency and respect for data subject rights, implementing strong safeguards internally and with vendors, and documenting decisions to demonstrate accountability. A must for sponsors aiming to embed GDPR compliance from Day 1.

Small biotech companies face the dual challenge of limited resources and global ambitions. This session offers a biotech sponsor’s perspective on leveraging outsourced partnerships to deliver Phase II and III trials successfully. Discussion will focus on practical challenges and lessons learned in CRO-sponsor collaboration, and how small biotech can transform vendor relationships into engines that drive trial execution while maintaining speed, quality, and control across borders.

In the fast-paced world of clinical development, small to mid-sized biopharma teams must evolve quickly to stay competitive. As trials grow in complexity, success depends on building strong, adaptable relationships—internally and with key partners. This session explores how clinical teams can scale effectively by shifting mindsets, fostering collaboration, and developing agile habits that drive performance, resilience, and long-term growth in an ever-changing trial landscape.

Clinical trials have a notoriously high failure rate. Evidence shows that the inclusion of effective biomarkers can double the success rate of clinical trials.This presentation explores precision medicine technologies that can serve as companion diagnostics for both small and larger pharmaceutical companies, helping to improve patient selection, strengthen evidence generation, and increase approval rates for anti-inflammatory drugs.We will also highlight data-driven strategies that enable smarter trial design and combinational biomarkers can enhance success rates in drug development for conditions such as inflammatory bowel disease (IBD) and rheumatoid arthritis (RA)”