Boston | October 20-21, 2026
Powerful Community, Fresh Ideas
Agenda
Monday, October 19
Tuesday, October 20
A global biopharma is leveraging Vault AI and Development, Quality, and Commercial Clouds to drive innovation from clinical studies through commercialization. Hear how ³Ô¹Ï±¬ÁÏ¡¯s AI strategy and the multi-vault approach is helping the company standardize and simplify operations.
Discover how Lilly leverages agentic AI to reshape its regulatory operations. Gain insight into ³Ô¹Ï±¬ÁÏ’s AI vision and how innovations will work together to augment teams, accelerate processes, and transform regulatory work.
Associate VP, Regulatory Delivery & Excellence
Industry leaders explore quality¡¯s role in generating business value in the AI era. Hear practical lessons on scaling AI across the enterprise and how they’re improving efficiency and governance to address intensifying competition, data security concerns, and evolving HA guidance.
UCB unified global safety operations and safety science on a single platform with a big bang approach, replacing fragmented legacy systems and establishing a single source of truth for safety data. Hear how UCB improved traceability from signals back to source data, simplified end-to-end processes, and built a foundation for automation and more efficient benefit-risk decision making.
Head of Digital Technology Patient Safety
Head Global Pharmacovigilance Reporting Operations
Discover ³Ô¹Ï±¬ÁÏ¡¯s vision for agentic clinical trials. Learn how a connected clinical platform enables upcoming AI agents and why effective change management is essential to realize its full value.
Standard agents help Vault users complete manual and repetitive tasks. See an overview and use cases for Vault Platform Standard Agents, including document agents, object agents, version comparison agents, super agents.
Learn how to publish an eCTD 4.0 submission using ³Ô¹Ï±¬ÁÏ Submissions Publishing and preview eCTD 4.0 forward compatibility – all within the same process used today.
Product Manager, Submissions Publishing
Learn about how ³Ô¹Ï±¬ÁÏ QualityDocs can provide regulation change impact assessments through document to regulation mapping.
Senior Director, QualityDocs Strategy
Senior Solution Consultant, Quality
See how Vault AI gives CRAs real-time visibility into site enrollment, priority issues, and upcoming monitoring visits, helping them work more proactively and focus on trial success.
³Ô¹Ï±¬ÁÏ¡¯s connected platform automates data flow across RTSM, EDC, eCOA, and Safety. See how connected applications eliminate duplicate data entry, reduce reconciliation, and accelerate workflows across the clinical ecosystem.
Solution Consultant, Clinical Data
AI experimentation is everywhere, but the needle has yet to move on sustainable value. Hear ³Ô¹Ï±¬ÁÏ’s thinking on how to turn innovative potential into bottom-line reality for your organization.
Head of R&D Business Consulting
Learn how to build and configure custom Vault AI agents in Vault Platform to automate business processes.
Learn how to locate, review, and bulk-disposition market-specific changes using the interactive Assess Local Activities Viewer. Discover how to utilize the grid’s filters, grouping, and fastfill to manage changes simultaneously.
Product Manager, Registrations
Explore recent quiz updates in ³Ô¹Ï±¬ÁÏ Training and preview the future roadmap. See how features like Pre-Quizzes and Dynamic Sections improve training efficiency and test security with live demonstrations.
Learn how a trusted reference data foundation drives workflow efficiency, connected-system alignment, and a better experience for investigators, sites, and sponsors.
Learn how ³Ô¹Ï±¬ÁÏ DQS drives RBQM, delivering real-time KRI/QTL metrics to CTMS while promoting compliance with ICH E6(R3). Preview upcoming features that automatically map incoming data to protocol endpoints, classify it by criticality, and link to an executable Data Review Plan.
Senior Solution Consultant
Automated TMF is the first step on a journey to extraordinary impact. Hear about ³Ô¹Ï±¬ÁÏ’s vision for Agentic ClinOps, and our plan for organizational transformation
VP, Global Clinical Operations Business Consulting
Explore Vault Platform advancements that simplify implementation, customization, and ongoing management. See how to use process monitor, Word-formatted outputs, action triggers, and reporting, and preview of upcoming ³Ô¹Ï±¬ÁÏ AI capabilities.
SVP ³Ô¹Ï±¬ÁÏ, Vault AI and Vault Platform
Review recent enhancements to ³Ô¹Ï±¬ÁÏ Registrations, ³Ô¹Ï±¬ÁÏ Submissions, ³Ô¹Ï±¬ÁÏ Submissions Publishing, and ³Ô¹Ï±¬ÁÏ Submissions Archive, along with this year’s roadmap priorities. Updates include Vault AI for Regulatory, Labeling, eCTD 4.0, Active Dossier, Global Content Plans, and other capabilities that streamline data management and end-to-end regulatory processes.
Vice President, Product Management, Regulatory
Explore the roadmap and vision for ³Ô¹Ï±¬ÁÏ QMS. See how the latest innovations streamline quality management.
Senior Director of Product Management
Discover what¡¯s next for ³Ô¹Ï±¬ÁÏ Training and LearnGxP. Explore the roadmap for transforming learner engagement and see the latest innovations in action.
Senior Product Manager
General Manager, LearnGxP
Director of eLearning Compliance
Discover the vision and roadmap for ³Ô¹Ï±¬ÁÏ Validation Management. See the latest innovations and hear about upcoming enhancements.
Director – Product Management
Hear the roadmap and vision for ³Ô¹Ï±¬ÁÏ LIMS. Dive into recent highlights and discover upcoming features.
Director, Product Management, LIMS
Hear what¡¯s planned for the ³Ô¹Ï±¬ÁÏ Safety application, including automation and AI capabilities to improve process efficiency, increase data quality, and simplify global compliance.
VP, Product Management
Discover recent enhancements to ³Ô¹Ï±¬ÁÏ CTMS, Payments, Disclosures, and OpenData Clinical. Learn about upcoming features that streamline risk-based quality management, fee generation, and reference data workflows. Preview AI agents to automate invoice intake, budget creation, and protocol extraction.
Senior Product Manager
Senior Product Manager, Clinical Operations
Discover the latest enhancements to ³Ô¹Ï±¬ÁÏ eTMF, Study Startup, Site Connect, and Study Training. Learn how new innovations improve inspection readiness, document exchange, feasibility, and training.
Senior Product Manager, Site Connect
Senior Product Manager
Discover what¡¯s next for ³Ô¹Ï±¬ÁÏ DQS, EDC, and eCOA. Learn about innovation delivering this year, including RBQM, patient engagement, and AI agents for study build, data classification, and programming.
Senior Vice President, Clinical Data
Vice President, Product Management eCOA
Real industry progress happens when site experience drives sponsor strategy. In this inaugural year session, Site Advisory Council leaders take the stage to advocate for the critical needs of site staff and trial participants directly to sponsor and CRO leadership. Gain first-hand insights into site friction points, explore collaborative solution frameworks, and help shape the next era of site-centric technology.
Immediately following the Clinical Data roadmap, join ³Ô¹Ï±¬ÁÏ¡¯s product team for an interactive Q&A about ³Ô¹Ï±¬ÁÏ eCOA.
Vice President, Product Management eCOA
Immediately following the Clinical Data roadmap, join ³Ô¹Ï±¬ÁÏ¡¯s product team for an interactive Q&A about ³Ô¹Ï±¬ÁÏ DQS and EDC.
Senior Vice President, Clinical Data
Explore the current research technology landscape as industry leaders from UPenn, AMR Clinical, and UCLA unpack the biggest headwinds and top priorities for Principal Investigators today.
Senior Vice Dean, Clinical and Translational Research
Principal Investigator and Regional Medical Director
Chief Medical Office for Clinical Research
General Manager, Site Solutions
Discover how the Vault MCP Server and Vault Documentation MCP Server allow Vault applications or external AI tools to invoke Vault AI agent actions and search official Vault Documentation.
Developer Support Engineer
Learn how Vault AI in ³Ô¹Ï±¬ÁÏ LIMS speeds laboratory workflows through automation. See AI in action, including SOP-to-test definition generation, COA ingestion, and a stability review chat agent.
Senior Solution Consultant, ³Ô¹Ï±¬ÁÏ LIMS
Director, Product Management, LIMS
Learn how ³Ô¹Ï±¬ÁÏ¡¯s TMF Maturity Model supports your eTMF success and paves the way for adoption of autonomous TMF.
Director, TMF Strategy
AI will reshape Data Management, drastically reducing effort for builds and cleaning, and accelerating DBL. Hear about ³Ô¹Ï±¬ÁÏ’s vision for the future and what it will take to achieve.
Associate Vice President, Global Clinical Data Business Consulting
Explore the current research technology landscape as industry leaders from UPenn, AMR Clinical, and UCLA unpack the biggest headwinds and top priorities for Principal Investigators today.
Senior Vice Dean, Clinical and Translational Research
Principal Investigator and Regional Medical Director
Chief Medical Office for Clinical Research
General Manager, Site Solutions
Amgen will share how Vault Platform, data, AI, and digital product strategies shaped a scalable foundation for digital transformation. Applying Clean Core principles and cross-functional governance across Vaults, the team is reducing complexity, strengthening standards, and enabling faster innovation.
Executive Director, Technology – ³Ô¹Ï±¬ÁÏ Enterprise Lead
³Ô¹Ï±¬ÁÏ has a vision for automation across Drug Development. But to realize value, organizations will need to rethink ways of working, governance structures, and team capabilities. Hear from an early Falcon adopter how they have re-engineered processes and are on the path to real Return on AI
See the future of agentic regulatory organizations in action. Experience ³Ô¹Ï±¬ÁÏ RIM’s newest capabilities through demonstrations and previews around how Vault AI, Falcon Regulatory, and Falcon Writer are evolving to solve critical regulatory challenges.
Senior Product Manager, Vault AI (RIM)
Senior Product Manager, Falcon
Director, Product Management, Falcon Writer
Executive Director, Falcon Regulatory Strategy
Learn how ³Ô¹Ï±¬ÁÏ is evolving document management and shop-floor access. Explore the vision and roadmap for QualityDocs and Station Manager.
Director of Product Management
Discover the vision and roadmap for ³Ô¹Ï±¬ÁÏ Batch Release. Review recent highlights and preview what’s next.
Senior Director, Product Management, ³Ô¹Ï±¬ÁÏ Batch Release
Hear how Pfizer is leading the industry by modernizing quality control and transitioning from legacy systems. Learn strategies to approach a transformative project while achieving quick wins and managing change.
Director, QC Operations Digitization and Master Data (IMOQ)
Learn about our newest product, ³Ô¹Ï±¬ÁÏ EHS. Hear the vision and strategy for a modern, streamlined approach to managing environmental, health, and safety processes.
After migrating from a vendor-hosted legacy database to a heavily customized in-house solution, Amylyx redesigned safety to align with ³Ô¹Ï±¬ÁÏ standard configurations. By adopting modern best practices, Amylyx is working more effectively with its CRO partner and gaining greater PV insights while scaling operations to prepare for commercialization.
Vice President, Patient Safety & Pharmacovigilance
Director, Pharmacovigilance Operations
Explore the product vision and roadmap for Falcon Clinical, including autonomous eTMF. Learn about the ³Ô¹Ï±¬ÁÏ Business Consulting framework to prepare your organization for agentic clinical operations, with customer examples and practical guidance.
Vice President, Falcon Clinical and Head of TMF
VP, Global Clinical Operations Business Consulting
Explore the vision to revolutionize clinical data, from AI to RBQM and eSource. Hear the world¡¯s largest CRO share its partnership journey over the past year, along with the plan ahead to scale critical innovations.
Vice President, Head of Clinical Data Management and Data Sciences Innovation
Discover how ³Ô¹Ï±¬ÁÏ SiteVault’s unified platform has created a connected core framework for site business operations, sponsor integration, and intelligent automation.
Learn how ³Ô¹Ï±¬ÁÏ Labeling will provide real-time oversight of global-to-local alignment and inspection readiness. See how it will streamline the end-to-end labeling process from CCDS updates to local label submissions.
Director, Product Management, Labeling
³Ô¹Ï±¬ÁÏ Clinical Platform uses AI and automation to speed data flow from ³Ô¹Ï±¬ÁÏ eSource, EDC, eCOA, and RTSM into ³Ô¹Ï±¬ÁÏ DQS. See how DQS uses AI to classify incoming data by criticality, and automatically creates protocol deviations in ³Ô¹Ï±¬ÁÏ CTMS.
Senior Manager, North American Solution Consulting, Clinical Data
Agents will not replace strategic thinking or health authority relationships, but there’s considerable potential for efficiency in the highly complex processes of RegOps. Hear from ³Ô¹Ï±¬ÁÏ about our vision for the transformation potential and the organizational steps to get there.
Associate Vice President, Global Regulatory Business Consulting
GSK streamlines end-to-end quality and regulatory processes with the Quality-RIM Connection. Hear key strategies and realized efficiencies, including how a connected approach speeds up regulatory assessments and ensures compliance.
Learn how Emergent and Regeneron are building a high-quality data foundation to move beyond document-centric processes. Discover how a data-driven approach helps proactively manage regulatory changes, increase confidence in submission data, and improve global regulatory operations.
Senior Director, Regulatory Affairs
Senior Manager – Regulatory Information Management & Innovation
Director, Regulatory Strategy
Join Cytokinetics, Kailera, and Novavax to examine how the RegOps role has expanded to include submission management, data strategy, system ownership, and cross-functional leadership. Learn how evolving regulations and technology are reshaping the role.
Executive Director, Regulatory Operations and Submission Management
Senior Director, Regulatory Operations
Executive Director, Global Regulatory Affairs Operations
Director, Regulatory Strategy
³Ô¹Ï±¬ÁÏ shares its 2030 vision of humans and agents working together and how this will drive efficiency and proactive quality. Learn successful transformation strategies that center on key business problems, focus on value, and align people, processes, applications, and agents to drive results. Understand how ³Ô¹Ï±¬ÁÏ solutions are evolving to support the industry journey.
VP, Global Quality Business Consulting
Biogen modernized global pharmacovigilance operations with a connected safety platform. Explore how the PV team brought global and affiliate case processing into a single safety solution, improving data quality and oversight while simplifying compliance. Hear operational readiness best practices that supported a seamless implementation and go-live.
Director, Global ICSR Processes and Systems
Discover how Kailera uses ³Ô¹Ï±¬ÁÏ eTMF and Study Training for real-time oversight and compliance amid rapid trial growth. Learn how the company drives inspection readiness through a risk-based approach and QC risk rules.
Associate Director, Clinical Systems
Amgen implemented a single rollout of ³Ô¹Ï±¬ÁÏ CTMS, Study Startup, Study Training, and Site Connect to streamline trial execution. Hear best practices for increasing productivity through automation, improving data quality, and strengthening site engagement.
Development Operations Innovation Director
Oruka Therapeutics optimized data quality and achieved faster database lock. Learn how it brought data ownership in-house to allow for greater oversight, visibility, and streamlined collaboration using ³Ô¹Ï±¬ÁÏ EDC and DQS across multiple CROs.
Senior Director Clinical Data Management
Vice President, Biometrics
Senior Director, Strategy, Clinical Data (SMB)
Sanofi and a top biopharma are rethinking clinical processes and adopting an entirely new way of working at speed. Hear Sanofi¡¯s novel model to innovate with the Clinical Platform, with a path to RBQM, site success, and patient engagement. Learn how a top biopharma switched to the ³Ô¹Ï±¬ÁÏ Clinical Platform and see its next phase of innovation, including tackling the complexity of Integrated Data Review Plans (IDRPs).
Senior Director, Clinical Digital Transformation Implementation Lead
Join for an interactive discussion on current policy issues, their impact on clinical trials, and how ³Ô¹Ï±¬ÁÏ is advocating for sites.
Chief Editor
Vice President, Public Policy
Wednesday, October 21
Understand how Vault AI in the Vault Platform enables businesses to scale AI adoption within the same environment that manages data and documents. Explore Vault AI agent use cases across clinical, regulatory, safety, and quality.
SVP ³Ô¹Ï±¬ÁÏ, Vault AI and Vault Platform
Gain practical insights from AstraZeneca and BioMarin as they share approaches to identify and prioritize use cases for AI, early lessons learned, and plans for scaling adoption.
Executive Director, Falcon Regulatory Strategy
Senior Director, Regulatory Systems
Senior Director, Regulatory Information Management and Technology
Associate Vice President, Global Regulatory Business Consulting
Discover how Merck and Takeda are using ³Ô¹Ï±¬ÁÏ Registrations to build a robust data foundation, giving the business greater ownership and visibility into its data.
Senior Director Health Registration Management
Director, RIM
Senior Director, Regulatory Strategy
Brook Darnell shares how Tolmar¡¯s learning ecosystem evolved to empower both GxP qualification and professional development. Hear how they went from paper based read and understand training to an engaging cross domain learning experience.
Senior Quality Systems Specialist – Training
Gilead shares insights on driving global process unity through its QMS enhancement program. Hear key considerations for navigating a changing product portfolio, aligning optimized business processes with system configuration, and fostering organizational alignment.
Executive Director, Quality
Principal, Quality Business Consulting
Discover ideas for successfully executing multiple ³Ô¹Ï±¬ÁÏ implementations. Learn how anchoring a massive software rollout to company values supports alignment.
Get a first look at new features for safety process and content management, advanced reporting, and signal detection. See how these enhancements enable more efficient global processes, deeper patient insights, and better informed decision-making.
VP, Product Management
Learn how Sarepta established a foundation for an optimized ³Ô¹Ï±¬ÁÏ CTMS through process standardization. Discover the impact on data quality, user adoption, and trial oversight¡ªand why aligning processes before configuring the system was key to its success.
Associate Director, Clinical Systems
Parexel shares how it standardized studies on a connected clinical platform to improve oversight, accelerate site activation, and improve data quality. Hear how simplifying technology for sites reduced risk and improved study execution.
Senior Director, Solution Enablement, Operational Excellence
Learn how Pacira, Indero, and Bayer modernized eCOA delivery. This session addresses traditional eCOA pain points to build faster, standardize processes, improve compliance, and simplify experiences for sites and patients.
Director, Clinical Data Management
Senior Director, Biometrics
VP, Clinical Digital Transformation
Preview ³Ô¹Ï±¬ÁÏ eSource’s next-generation capabilities, including CRF generation, EHR integration, and direct streaming to EDC which will simplify data flow from sites to sponsors.
Agent observability in Vault transforms AI from an opaque “black box” into a fully auditable system. See how Vault AI captures the complete lifecycle of every agent interaction, including step-by-step reasoning, context, tool invocations, and generated outputs.
Learn how to facilitate accurate batch release and product lifecycle management with Active Dossier by maintaining a list of current documents for a product in multiple markets.
Product Manager, Regulatory
Learn how ³Ô¹Ï±¬ÁÏ¡¯s milestone planning capabilities simplify complex trial timelines and how Vault AI streamlines feasibility and site activation.
Senior Solution Consultant
Discover how ³Ô¹Ï±¬ÁÏ eCOA Studio redefines industry standards by enabling sponsors to directly configure and manage their own study builds. See how this self-build approach eliminates vendor bottlenecks and outdated workflows, driving faster and more efficient execution.
Senior Solution Consultant, eCOA
Drop in and meet sponsors aligned with your therapeutic areas, patient populations, or studies of interest. Take advantage of dedicated networking time to build connections that can lead to future collaborations.
AI will streamline business processes. But on a granular level, there will be new complexities and decisions that go into each re-engineered process. Human in/on the loop, human-agent teaming, and more. Hear from ³Ô¹Ï±¬ÁÏ how we can support your Agentic process redesign.
AVP, Clinical Operations Business Consulting
Process Monitor is a Vault Platform capability that enables Vault users to measure and analyze critical business processes with zero configuration. See how to visualize processes, detect bottlenecks, and use key metrics to optimize performance.
Principal Product Expert, Vault Platform
Learn how to create a Global Content Plan as a baseline from a reference application using documents from Active Dossier, accelerating time to submission and approval.
Product Manager, Regulatory
Discover how Vault AI can automate the ingestion of supplier batch records directly into ³Ô¹Ï±¬ÁÏ. See how bridging the CDMO-Sponsor divide with intelligent automation eliminates manual file searching, retrieval, and analysis to drive faster, more confident release decisions.
Director, Batch Release Strategy
Solution Consultant, ³Ô¹Ï±¬ÁÏ Batch Release
Discover new Clinical Transfer and Oversight Planning capabilities that improve sponsor-CRO collaboration and streamline study oversight.
Principal Consultant, North America R&D Business Consulting
Product Manager
The appropriate governance of Agents in the workforce goes far beyond traditional software governance. New skills and capabilities are required, new structures need to be stood up. Hear ³Ô¹Ï±¬ÁÏ’s perspective on what should be in place to make Agentic R&D work inside your company.
Associate Vice President, R&D Business Consulting
See the latest ³Ô¹Ï±¬ÁÏ Connections capabilities and upcoming enhancements. Discover how to streamline cross-functional business processes, improve data quality, and automate workflows.
Discover how National Marrow Donor Program uses ³Ô¹Ï±¬ÁÏ Process Monitor to analyze and optimize business processes. This session will demonstrate how to visualize process flows, identify bottlenecks, and easily track process KPIs like cycle time.
Senior Application Business Owner
See how Lilly used Global Content Plans to deliver 40 submissions across 40 countries in just 40 days.
Product Owner, RIM Publishing
Manager, Global Regulatory RD&E
Learn how Aquestive built a business case for continuous publishing. Hear how working with a skilled publishing partner mitigates risk while keeping teams in control of timelines and quality.
Regulatory Technical Writer
Managing Partner
Director, Regulatory Strategy
Managing Partner
Discover how Veloxis demonstrates training value beyond ¡°checkbox compliance¡± using a focused, organizational Training Matrix and applying ROI principles.
Senior Director, QMS and Compliance
A biopharma shares the drivers and decisions behind its quality transformation to establish a unified QMS across seven subsidiaries. Learn how streamlining supplier quality and document management improved efficiency across the organization.
Learn lessons learned on LIMS selection and implementation from a panel of virtual biopharmas. Hear ways to enhance partner oversight, ensure compliance, and scale operations.
Discover how a virtual biopharma built a commercial-grade release process across a multi-CMO supply chain while racing toward its first NDA.
Top biopharma modernized management of its pharmacovigilance agreements (PVAs) by centralizing content and related PVA processes, including contract and obligation creation, management, and tracking. Explore how a digital solution automates global partner oversight and improves audit readiness and scalability.
A top biopharma shares best practices to centralize disclosures on the ³Ô¹Ï±¬ÁÏ Clinical Platform. Learn how standardizing workflows across ³Ô¹Ï±¬ÁÏ eTMF and CTMS improves compliance and efficiency.
Johnson & Johnson shares how it replaced legacy technology with a unified site training approach. Learn how integrating training with eTMF reduced site burden, improved compliance, and lowered overhead.
Manager, Clinical Trial Learning & Training
Sponsors can get quick access to ³Ô¹Ï±¬ÁÏ innovations through accredited CRO partners. Hear how Celerion delivered studies on their ³Ô¹Ï±¬ÁÏ platform for sponsor speed, flexibility, and oversight.
Vice President Global Scientific Clinical Operations
Executive Director, Global Project Management & Strategic Solutions
Director, Clinical Data Management – EDC
³Ô¹Ï±¬ÁÏ Vault Administrator
Hear how Lilly and Bayer maximize clinical data value with ³Ô¹Ï±¬ÁÏ DQS, EDC, and Clinical Platform connections. Learn how they automate data ingestion and up to 50% of queries to speed cycle times, reduce manual effort, and improve data quality.
Director, Clinical Trial Foundations, Clinical Result Systems
Head Of Data Provisioning
Get a look into open-source tools that increase administrator and developer productivity. Built with Vault API and an intuitive user interface, easily modify configurations, execute queries, clean up sandboxes, and more.
Developer Support Engineer
Discover how optimized complaint intake, via intelligent automation, can help reduce errors, drive consistency, improve data quality, and shorten cycle times.
Senior Director, ³Ô¹Ï±¬ÁÏ QMS Strategy
Principal Product Manager
Explore the new Site Connect – Study Plan capability and learn how to implement it successfully with change management strategies that accelerate adoption.
VP, Global Clinical Operations Business Consulting
See how ³Ô¹Ï±¬ÁÏ DQS automates the detection and transfer of PDs into ³Ô¹Ï±¬ÁÏ CTMS via the new Clinical Operations ¨C DQS Connection, cutting protocol deviation processing time from weeks to hours.
Senior Solutions Consultant
In ten years, the Safety function will look very different and be focused on high-value, judgement-based tasks. Hear from ³Ô¹Ï±¬ÁÏ how we see this developing and what it will take to get there.
Machine translation for documents within Vault eliminates manual Vault user workflows and custom code . See how to initiate automatic translations to accelerate localization workflows and streamline global delivery.
Explore how ³Ô¹Ï±¬ÁÏ RIM connects key data and business processes with Clinical, Quality, Safety, Medical, and PromoMats. Learn about key enhancements from the last 12 months and future roadmap features.
Senior Product Manager, RIM Connections
Discover how the new Contract Ingestion Agent works alongside ³Ô¹Ï±¬ÁÏ EDC and Site Connect to accelerate site payments.
Preview ³Ô¹Ï±¬ÁÏ eSource, a new application for sites. See how ³Ô¹Ï±¬ÁÏ eSource connects with ³Ô¹Ï±¬ÁÏ EDC to eliminate paper, reduce the need for SDV, and simplify data collection for sites, data managers, and CRAs.
Solution Consultant, Site Solutions
An Agentic Quality transformation involves identifying high-value business problems, developing agents to address them, embedding their usage in workflows, changing operating models, and upskilling talent to orchestrate. Hear from ³Ô¹Ï±¬ÁÏ how we can help structure the journey.
VP, Global Quality Business Consulting
Explore recent enhancements to Vault Reporting and Dashboards, including Aggregate Formulas, which simplify advanced data summarization. Plus, get an early look at the high-impact features coming on the near-term roadmap.
Senior Director of Product, Vault Platform
Learn how BeOne is reducing duplication, increasing visibility, and simplifying health authority interactions using ³Ô¹Ï±¬ÁÏ RIM and the Accumulus Connector.
Senior Director, Government Strategy
Associate Director, Global Regulatory Solutions Enablement
Discover how Roche and Teva are relieving the downstream burden on publishers and accelerating high-volume regulatory submissions with ³Ô¹Ï±¬ÁÏ Submissions Publishing.
Senior Regulatory Submission Manager
Senior Director, Head of Global Regulatory Operations
Explore release management best practices that derive maximum value from your Quality Cloud investment. Learn proven strategies for small and midsize businesses to stay current with ³Ô¹Ï±¬ÁÏ releases.
Executive Director, IT – Drug Development, Supply Chian and Quality
Top biopharmas share how they broke down IT and quality silos to reimagine validation. Learn practical takeaways on shifting from fragmented legacy tools to a modern, unified platform for validation and quality.
See how a CDMO improved quality control by switching paper for digital-first method execution. Understand how a true-cloud LIMS directly impacts workflows and client relationships.
Hear Ionis discuss implementing Audit Room within QMS to transform regulatory audit management. Learn how this tool helps GxP business functions maintain continuous inspection readiness.
Assistant Director, GxP Quality Systems | GMP Vendor Management
Assistant Director, Development IT Portfolio
Incyte shares its strategy and business case for a global, connected safety system. Discover how eliminating redundant technology and standardizing data and workflows is improving data quality while establishing a scalable foundation for AI and automation.
Vice President, Global Pharmacovigilance
Principal Business Consultant
Keenova shares how it is moving TMF quality reviews from spreadsheets to ³Ô¹Ï±¬ÁÏ eTMF. Managing review scope, findings, and corrective actions in a single system improves efficiency and enables a proactive approach to inspection readiness.
Director eTMF & Inspection Readiness
Learn how to use risk-based approaches to improve data quality and accelerate study execution. ³Ô¹Ï±¬ÁÏ experts share strategies for implementing RBQM with ³Ô¹Ï±¬ÁÏ CDB and ³Ô¹Ï±¬ÁÏ CTMS while aligning with evolving ICH E6 standards.
Associate Vice President, Global Clinical Data Business Consulting
Hear directly from sponsors as they share their perspectives on site training, feasibility, and payments, along with the initiatives they’ve implemented to strengthen site partnerships.
See how to automate and streamline submission document collection across clinical (TMF), regulatory, quality, and commercial (promotional material), improving efficiency and accelerating submissions.
Senior Director, Development Cloud Strategy
Director, North American Solution Consulting, ³Ô¹Ï±¬ÁÏ Connections & Process Excellence
Explore key considerations for building a modern validation strategy. Learn how a data-centric approach to digital validation can overcome the limitations of early paperless solutions.
Senior Director, Validation Management Strategy
Senior Solution Consultant, Validation Management
Learn how ³Ô¹Ï±¬ÁÏ Disclosures streamlines EU CTR compliance and global submissions with the new Protocol Extraction Agent.
Senior Product Manager
Connect ³Ô¹Ï±¬ÁÏ EDC with ³Ô¹Ï±¬ÁÏ Safety to reduce transcription by up to 75% and speed case processing by 50%. Automatically transfer adverse event data to eliminate duplicate entry, reduce intake errors, and simplify reconciliation.
Senior Solution Consultant
Organizational Designs will need to evolve with Agentic ways of working. It’s not as simple as “finding efficiencies”. Hear ³Ô¹Ï±¬ÁÏ’s perspective on how to think about this source of value, and how ³Ô¹Ï±¬ÁÏ can help.
Head of R&D Business Consulting
Connect with ³Ô¹Ï±¬ÁÏ product managers and peers for an in-depth discussion on ³Ô¹Ï±¬ÁÏ Submissions Publishing. Discuss how to streamline submission workflows, reduce redundant local market tasks, and strike the right balance between strict Health Authority (HA) requirements and traditional internal practices.
Product Manager, Submissions Publishing
Connect with your peers and the ³Ô¹Ï±¬ÁÏ product team for a discussion and feedback session about Active Dossier, Global Content Plans, and Submission Content Plans.
Product Manager, Submissions
Product Manager, Regulatory
The Create and Manage Event Details (CMED) wizard is the starting point for managing changes in ³Ô¹Ï±¬ÁÏ RIM, eliminating repetitive, manual entry. Join your peers to preview the product roadmap and share feedback.
Senior Product Manager, Registrations
Product Manager, Registrations
Explore best-practice Labeling workflows, data model, and implementation accelerators to prepare for ³Ô¹Ï±¬ÁÏ Labeling in 2027.
Senior Director, ³Ô¹Ï±¬ÁÏ Labeling
Director, Product Management, Labeling
Regeneron discusses how bringing together Quality and IT stakeholders during its QMS implementation helped advance its paperless plant and digital transformation goals. By establishing early alignment and leaning into out-of-the-box configuration, Regeneron streamlined validation, reduced timelines, and built a scalable foundation for quality management.
Explore how to prepare teams and pharmacovigilance operating models to maximize Return on AI (RoAI) and establish a clear path to agentic safety.
Explore the major 2026 enhancements that bring Risk-Based Quality Management (RBQM) to ³Ô¹Ï±¬ÁÏ CTMS. Learn how to establish Critical to Quality (CtQ) factors and define study-specific risks, mitigations, and critical processes within the system. See how automated Key Risk Indicator (KRI) data ingestion triggers real-time risk remediation workflows when thresholds are breached.
Senior Product Manager, Clinical Operations
Learn how to set up and configure the TMF Quality Understand feature in ³Ô¹Ï±¬ÁÏ eTMF. Review how to use risk-based or flat sampling to target finalized documents by country, site, or trial event. Discover how these workflows confirm documentation cohesiveness directly in Vault to drive continuous inspection readiness.
Senior Product Manager, ³Ô¹Ï±¬ÁÏ eTMF
Discover ³Ô¹Ï±¬ÁÏ¡¯s vision to elevate and scale Clinical Data teams on strategic activities through agentic AI automation. Explore how to build organizational readiness, accelerate AI adoption, and establish a clear path to maximize your Return on AI (ROAI).
Associate Vice President, Global Clinical Data Business Consulting
Chief Technology Officer, Clinical Data