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Why Attend?

A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES

Engaging keynote presentations from industry luminaries, panel discussions featuring perspectives from diverse stakeholders, networking sessions to connect with peers and experts, exhibition area showcasing innovative solutions and technologies, opportunities to interact with FDA representatives and regulatory experts.

The programme will feature a range of speakers from the likes of FDA, Gilead Sciences, Eli Lilly and Company, Takeda, Genentech Roche Group, and many more, who through a variety of interactive session formats will offer insight on promoting successful clinical data management.

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Agenda

  • 9 Sep 2026
  • 10 Sep 2026
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8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

9 AM

PANEL The Future of Clinical Data Management: Trends, Technology, and What’s Next

  • Key trends reshaping clinical data management and how leading teams are responding
  • Looking at the biggest operational and technology challenges and overviewing practical solutions
  • What to expect over the next 3–5 years and how to stay ahead in capability, speed, and quality

Panel seat reserved for event sponsor

Speakers

Amir Momen-Roknabadi
Director of Artificial Intelligence, Therna Biosciences
Kevin Tsai
Senior Director Data Engineering, Data Platform, Genmab US
Brian Merry
Manager, Data Management , Insmed
Rishi Raj
Clinical Data Strategist & Innovation Lead, Sensan Bio

9:45 AM

Reserved for event sponsor

10:15 AM

INDUSTRY CASE STUDY An introduction to Agentic AI in Clinical Data Management: What It Is, Where It Fits, and How to Start Safely

  • Defining agentic AI and its capabilities to understand how it works and how it differs from automation and traditional rule-based workflows
  • Understanding where it fits in regulated clinical environments and how it could be used to enhance clinical processes
  • Evaluating real-world use cases and identifying actionable opportunities to scale and apply Agentic AI in data teams

Speakers

Alex Liu
Associate Director, Clinical Systems, Taiho Oncology

10:45 AM

Morning refreshments and networking break

11:15 AM

Clinical data management innovation in practice: AI, analytics, and strategic partnerships across sponsors & CROs

  • Understanding how analytics can support better visibility into study progress and data quality
  • Enhancing sponsor and CRO collaboration to work together more effectively
  • Integrating data from multiple sources to create usable study datasets faster
  • Adopting innovation while maintaining appropriate governance and compliance

Speakers

Rishi Raj
Clinical Data Strategist & Innovation Lead, Sensan Bio

11:45 AM

Session reserved for event sponsor

12:15 PM

PANEL Strengthening data integrity processes to protect patient safety and reduce risk in clinical studies

  • Preserving data integrity across processes to ensure patient safety and minimize potential risk
  • Implementing strategies that increase data quality and reduce timelines
  • Prioritizing risk minimization to enhance a patient safety

 

Panel seat reserved for patient advocate

Panel seat reserved for event sponsor

Speakers

Astha Bhatia
MPH, DMD, Senior Director, Clinical Scientist, EvolveImmune Therapeutics

1 PM

Lunch and networking

2:15 PM

INTERACTIVE WORKSHOP Building a future ready clinical data strategy in an increasingly complex study landscape

Concept: This interactive workshop is designed to help attendees modernize their clinical data strategy. Through real examples and guided exercises, participants will review their current approach, spot the biggest pain points in clinical data flow, and outline a clear path to a more connected, scalable data ecosystem

Takeaway: Attendees will leave with a simple, actionable framework they can use to strengthen their clinical data strategy and streamline clinical processes

Speakers

Dinesh Pillaipakam
R&D Data Products Enablement, BeOne Medicines

2:45 PM

Adaptive trial designs and RWE: Leveraging the FDA’s streamlined processes for accelerated approvals

  • Understanding how to use Real World Evidence to strengthen submissions and ensure approval in a timely manner
  • Overviewing regulation to ensure compliance and reduce delays in clinical trial submissions
  • Identifying challenges in adaptive trial designs to mitigate risk and ensure successful running of your clinical study

Speakers

Binoy Amin
PharmD, Associate Director, Real World Data Strategy, Informatics, and Science, Novo Nordisk

3:15 PM

CASE STUDY Building an AI-Ready Data Platform for Tomorrow’ Clinical Data Management: Context, Metadata, and Governance for AI

  • Traditional data management focuses on harmonization and data standards; but AI now requires rich metadata, semantic context, and governed relationships to effectively understand data as humans do
  • Embedding and centralizing metadata, governance, and business context directly into the data platform's process (“shift-left”) improves consistency and accuracy of context capture
  • Applying this approach to SDTM and clinical submission data can help accelerate FDA submission activities by enabling AI-assisted generation, validation, traceability, and review of regulatory deliverables using a governed clinical context.

Speakers

Kevin Tsai
Senior Director Data Engineering, Data Platform, Genmab US

3:45 PM

Afternoon refreshments and networking

4:15 PM

How to outsource in clinical data management effectively: Governance, quality, and control without losing speed

  • Exploring practical strategies for outsourcing CDM functions to support successful clinical study delivery
  • Establishing clear governance and communication models with vendors to enhance efficiency and maintain data quality and oversight
  • Leveraging vendor capabilities effectively while sticking to budget and without compromising operational control

Speakers

Sumita De
Director, Data Enablement - Head of Integrations, Regeneron

4:45 PM

ASK THE EXPERTS PANEL What are the biggest challenges in data management right now and what can I do to prevent roadblocks in study timelines?

Concept: This is an audience-led panel where data experts respond in real time to the most pressing data management challenges attendees are dealing with today. The conversation is driven by live Q&A with questions that have been submitted on Slido during the session

Takeaway: Attendees will leave with a clear view of the most pressing data management challenges impacting organizations right now and leave practical, immediately usable strategies to address them

 

Panel seat reserved for event sponsor

Speakers

Stephen Duprez
Director, Clinical Data Management, CorMedix Therapeutics
Madhu Kumar
Head of Data Management, BlueRock Therapeutics
Satish Dachepally
Director of Clinical Database Programming, Incyte

5:15 PM

END OF DAY ONE

8:15 AM

Registration and refreshments

8:45 AM

Chairperson’s opening remarks

9 AM

🗣️ INTERACTIVE BOARDROOM Using AI tools effectively: How can AI existing tools be used better to support data quality without adding complexity?

These collaborative team-building exercises, provide a focused opportunity to work alongside your peers to tackle common clinical data management challenges and develop practical, actionable solutions. Each session begins with a concise 10-minute problem statement presented by the session lead, setting the context and clarifying the key question to solve.

Participants then move into a 30-minute “whiteboard” working session, where each table co-develops a draft framework or potential solution to the challenge. To close, each table briefly summarizes its proposed approach, allowing the wider group to compare perspectives and walk away with multiple actionable solution pathways.

Speakers

Michael Steinbaugh
Director, Data, AI, and Genome Sciences, Merck
Brian Merry
Manager, Data Management , Insmed

10 AM

Reserved for event sponsor

10:30 AM

Morning refreshments and networking break

11 AM

PANEL How to manage unique datasets effectively to stick to study timelines while minimizing risk

  • Overviewing the challenges faced when managing unique datasets in clinical studies to understand how to mitigate roadblocks effectively
  • Planning ahead to implement effective risk mitigation strategies to ensure your trial stays on track

Panel seat reserved for event sponsor

Speakers

Anil Tarachandani
VP and Head of Translational Medicine, Verge Genomics

11:45 AM

Reserved for event sponsor

12:15 PM

INTERACTIVE WORKSHOP – PART 1 Building a reliable forecasting framework for clinical data management trends

Concept: This first session introduces a structured, repeatable approach to predicting trends and future needs in clinical data management. Through guided discussion, participants will establish a simple method to score impact vs. likelihood vs. time-to-materialize and connect forecast outputs to practical planning choices

Takeaway: Attendees will leave with a clear, step-by-step forecasting framework that they can use to consistently predict and prioritize what’s next in clinical data management

Speakers

Marina Darlow
Incubation Lead, AI Tools for Pharma Research and Reporting, Takeda

12:45 PM

Lunch and networking

2 PM

INTERACTIVE WORKSHOP – PART 2 Putting the framework to the test: Hands-on trend forecasting for clinical data management

Concept: This is the practical second half of the workshop, where attendees use real examples to test and refine the trend forecasting framework. Working through guided scenarios, participants will identify signals and translate outputs into concrete decisions.

Takeaway: Attendees will leave having validated the framework through hands-on practice, with a completed sample forecast and a reusable template they can take back to apply to their own clinical data management processes

Speakers

Marina Darlow
Incubation Lead, AI Tools for Pharma Research and Reporting, Takeda

3 PM

SOLUTION SPRINT

An opportunity for vendors to address real-world biopharma specific challenges.
In this fast-paced, interactive session a current, practical problem is presented, and speakers will respond with targeted solutions.

3:30 PM

Afternoon refreshments and networking

4 PM

SESSION TITLE TBC

Speakers

Anand Ganesan
Product Management -Global Development IT, Regeneron
Sriram Krishnamurthy
Director- Global Development – IT, Regeneron

4:30 PM

Lessons learned when implementing AI effectively to enhance rare disease clinical trials

  • Identifying where AI can enhance clinical trial processes for rare disease programs
  • Overviewing common challenges when introducing AI to clinical processes
  • Successfully implementing AI within teams to avoid delays and implementation challenges

Speakers

Anbu Damodaran
Associate Director of Statistical Programming, AstraZeneca

5 PM

END OF CONFERENCE

Speakers

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Alex Liu
Associate Director, Clinical Systems, Taiho Oncology

I oversee end-to-end EDC build and maintenance across multiple studies, ensuring compliant, high-quality, and on-time delivery. My experience spans study startup through database lock and archival, including eCRF standards and design oversight, validation strategy, UAT execution, release management, migrations, and post-production support. I provide direction and oversight across study build activities, driving consistent execution, accountability, and adherence to data integrity and quality standards throughout the clinical trial lifecycle.

Session Details:

INDUSTRY CASE STUDY An introduction to Agentic AI in Clinical Data Management: What It Is, Where It Fits, and How to Start Safely

2026-09-09, 10:15 AM

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Amir Momen-Roknabadi
Director of Artificial Intelligence, Therna Biosciences

Scientist and AI leader specializing in computational biology and machine learning applications in biotechnology. Proven track record in developing novel statistical methods and AI-driven platforms for RNA therapeutics and cancer diagnostics. Experienced in leading large-scale research initiatives and translating complex biological problems into scalable computational solutions. Recipient of multiple awards including the NIH Ruth L. Kirschstein NRSA Postdoctoral Fellowship.

Session Details:

PANEL The Future of Clinical Data Management: Trends, Technology, and What’s Next

2026-09-09, 9:00 AM

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Anand Ganesan
Product Management -Global Development IT, Regeneron

Experienced Consultant with a demonstrated history of delivering clinical IT projects for pharma, biotech/CROs with a Wharton Management Development Program, Kellogg Product Strategy and a Stanford Advanced Program Management from Stanford University. Anand is a tech savvy leader with interests in AI, big data, blockchain and use them to address the challenges faced by the life sciences industry. He is a big believer in product innovation and leads teams in product development. Anand loves participating in hackathons and social innovation activities in the life sciences/ healthcare space.

Session Details:

SESSION TITLE TBC

2026-09-10, 4:00 PM

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Anbu Damodaran
Associate Director of Statistical Programming, AstraZeneca

Session Details:

Lessons learned when implementing AI effectively to enhance rare disease clinical trials

2026-09-10, 4:30 PM

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Anil Tarachandani
VP and Head of Translational Medicine, Verge Genomics

Biotech executive with 20+ years of experience driving innovation at the intersection of science, medicine, and technology. Currently VP, Head of Translational Medicine at Verge Genomics, where I built the function from the ground up and advanced neurology programs through Phase 2/3 readiness using FDA-validated biomarkers. Previously at Pfizer, I led cross-functional teams delivering novel digital endpoints, secured FDA/EMA alignment, and helped advance Ponsegromab from Phase 1 to Phase 2/3. At Biogen, I drove digital diagnostics initiatives, advanced technologies in Alzheimer’s and stroke, and helped spin out a new venture. I also founded a digital diagnostics startup, Usin’Life, which exited with a few assets. Passionate about advancing therapies for patients with high unmet medical needs, I bring expertise in translational medicine, biomarker strategy (digital & fluid), regulatory engagement, using technology ( including AI/ML !) and partnerships across biotech, pharma, and academia.

Session Details:

PANEL How to manage unique datasets effectively to stick to study timelines while minimizing risk

2026-09-10, 11:00 AM

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Astha Bhatia
MPH, DMD, Senior Director, Clinical Scientist, EvolveImmune Therapeutics

Strategic Clinical Development Leader | Oncology & Beyond I am a strategic and science-driven clinical development leader with 16+ years of experience shaping global drug development across oncology (solid tumors & hematologic malignancies), cardiovascular, rare, and specialty medicine. Over my career, I have:

  • Directed global Phase I–III trials that informed pivotal approvals and label expansions
  • Led NDA/BLA submissions resulting in successful global filings and regulatory milestones
  • Built and guided high-performing cross-functional teams spanning Clinical Development, Biostatistics, Safety, Regulatory, and Clinical Operations
  • Partnered with KOLs, CROs, and regulators to navigate complex development pathways I’m known for bringing clarity and structure to complexity, aligning science with strategy, and driving decisions that accelerate development while upholding patient focus and data integrity. As a senior leader, I thrive in fast-paced, matrixed environments where strategy, adaptability, and communication define success. I am also deeply committed to mentorship and talent development, ensuring teams grow alongside programs. Specialties: Oncology Clinical Development | Global Regulatory Submissions | Trial Oversight | Medical Monitoring | Portfolio & Pipeline Strategy | Cross-Functional Leadership | Data-Driven Decision Making

Session Details:

PANEL Strengthening data integrity processes to protect patient safety and reduce risk in clinical studies

2026-09-09, 12:15 PM

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Brian Merry
Manager, Data Management , Insmed

Broadly speaking, I am a research professional dedicated to improving access to healthcare services, the development of novel and effective treatments for disease prevention, symptom relief, and cures, and improving the quality of care through a reduction in the occurrence of medical errors. My particular set of skills, acquired through education and experience, have made me adept at working with the data essential to tackling these issues.

Session Details:

PANEL The Future of Clinical Data Management: Trends, Technology, and What’s Next

2026-09-09, 9:00 AM

Session Details:

🗣️ INTERACTIVE BOARDROOM Using AI tools effectively: How can AI existing tools be used better to support data quality without adding complexity?

2026-09-10, 9:00 AM

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Dinesh Pillaipakam
R&D Data Products Enablement, BeOne Medicines

I lead R&D data enablement and data product strategy, building scalable, governed data foundations that transform data into a strategic asset across the Pharma R&D value chain. I focus on building high-quality, reusable, and interoperable operational data platforms and domain-specific data products that speed scientific outcomes, support advanced analytics and AI/ML, and deliver measurable business value. I work closely with stakeholders across Research, Clinical Development, Safety, Regulatory, and Portfolio & Project Management to ensure R&D data is discoverable, analytics-ready, and fit for decision-making. By applying data product thinking, strong governance, and modern data architecture principles, I help organizations move from siloed data to trusted, scalable, cross-domain insights. Core Competencies: R&D data foundations & data product strategy, Analytics- and AI/ML-ready data enablement, Data governance, Product Management, Clinical Data Management, Data Standards & Analytics, Decentralized Trials (DCT, DHT), Governance & Risk Oversight, AI & Digital Innovation, Stakeholder Management, Data Privacy & Security, Vendor Management, Design Thinking, Leadership Development, Certified Coach Technology, Tools, and Frameworks: Medidata Rave, Oracle Clinical, Veeva Clinical/Vault, Informatica, Reltio, Formedyx, Collibra, Python, VBA, Databricks, AWS Bedrock, UIPath, Redshift, SpotFire, Power BI, GCP, CDISC, 21CFRP11, RBQM, FHIR, CRISP-DM, V3+, LEAN

Session Details:

INTERACTIVE WORKSHOP Building a future ready clinical data strategy in an increasingly complex study landscape

2026-09-09, 2:15 PM

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Kevin Tsai
Senior Director Data Engineering, Data Platform, Genmab US

I’m a senior data and AI leader who builds production-grade data platforms and analytics foundations that make data trustworthy, accessible, and decision-ready at scale. My focus is on enabling self-service analytics, well-modeled datasets, and AI-powered data experiences across federated organizations. I currently lead enterprise data platform and analytics capabilities at Genmab, where I own a global lakehouse supporting thousands of users, PB-scale data, and mission-critical workloads across R&D and commercial teams. I’ve scaled global teams, owned multi-million-dollar platform budgets, and partnered closely with executives to align data strategy with business outcomes. Across biotech, consumer data, and consulting environments, I’ve built and operated data systems spanning ingestion, modeling, governance, analytics engineering, and AI enablement — balancing speed, trust, and operational rigor. Lastly, I'm passionate about building customer-centric data solutions embedded in federated domains, transformative enterprise capabilities and strategies, partner-centric collaboration, and creating great teams.

Session Details:

PANEL The Future of Clinical Data Management: Trends, Technology, and What’s Next

2026-09-09, 9:00 AM

Session Details:

CASE STUDY Building an AI-Ready Data Platform for Tomorrow’ Clinical Data Management: Context, Metadata, and Governance for AI

2026-09-09, 3:15 PM

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Madhu Kumar
Head of Data Management, BlueRock Therapeutics
Worked in the Pharmaceutical/Biotech/CRO industry since last 25 years with more than 23 years of experience in the Clinical Data Management area on both Sponsor & CRO Side. Successfully led multi-faceted data management project teams to globalize clinical data management processes, systems & organizations and currently working at Bluerock Therapeutics as the Head of Data Management / Director, Data Management. Handled and supported several Clinical Studies (Phase 1 to Phase 4) across various therapeutic areas like Immunology, Oncology, CV, CNS, & Rare diseases. Completely familiar with technology and its role in the Clinical Data Management space and performed/supported several technology related initiatives.

Session Details:

ASK THE EXPERTS PANEL What are the biggest challenges in data management right now and what can I do to prevent roadblocks in study timelines?

2026-09-09, 4:45 PM

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Marina Darlow
Incubation Lead, AI Tools for Pharma Research and Reporting, Takeda

I’m a strategic innovation leader passionate about shaping the future through collaboration, foresight, and action, with 10+ years of cross-industry experience leading AI-driven transformation, and idea-incubation programs. At Takeda, I lead cross-functional teams that turn bold ideas into real-world impact. Whether designing AI-augmented solutions, facilitating innovation sprints, or running strategic foresight labs, my mission is to empower people and systems to work smarter, faster, and more meaningfully. In my experience, the key piece of a successful concept-to-launch process is creating focus for the team. This requires continuous prioritizing and fluency in both tech and laypeople speak. I’m genuinely and deeply curious about the subject matter in my care, and it helps me translate ambiguous challenges into bold, scalable solutions, launch enterprise-wide innovation initiatives, and lead high-performing teams to deliver lasting impact. With a background in business analysis, agile coaching, and startup consulting, I thrive at the intersection of creativity, technology, and human-centered design. I’ve launched noteworthy MVPs, guided 60+ innovation champions, and delivered measurable results in complex environments. If you're looking to future-proof your organization, foster a culture of experimentation, and lead with empathy—let’s connect.

Session Details:

INTERACTIVE WORKSHOP – PART 2 Putting the framework to the test: Hands-on trend forecasting for clinical data management

2026-09-10, 2:00 PM

Session Details:

INTERACTIVE WORKSHOP – PART 1 Building a reliable forecasting framework for clinical data management trends

2026-09-10, 12:15 PM

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Michael Steinbaugh
Director, Data, AI, and Genome Sciences, Merck

Research scientist and team builder specializing in drug discovery, AI/ML, functional genomics, and RNA biology, with experience in clinical development from target identification through patient selection.

Session Details:

🗣️ INTERACTIVE BOARDROOM Using AI tools effectively: How can AI existing tools be used better to support data quality without adding complexity?

2026-09-10, 9:00 AM

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Parth Patel
PhD, MS, Executive Director, AI and Data Science, Madrigal Pharmaceuticals

With over 10 years of experience in data sciences, clinical informatics, bioinformatics, and AI-driven analytics, I am a passionate leader and innovator in the clinical and genomics field. As the Director of Data Sciences at Illumina, I leverage advanced technologies to create data-driven solutions that improve patient outcomes and accelerate innovation in the genomics industry. My core competencies include working with real-world data (EHR systems), clinical trial analytics, population genetics workflows, drug target discovery, and multi-modal next-generation sequencing data. I have extensive knowledge and experience in Python, R, SQL, Java, C/C++, Cloud computing (AWS, Azure), and deep learning frameworks. I also have a strong background in software development, database design, and high-performance computing. I enjoy collaborating with cross-functional teams, mentoring aspiring data scientists, and sharing my insights and expertise with the scientific community. My mission is to harness the power of clinical and genomics data and AI/ML to advance precision medicine and healthcare.

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Rishi Raj
Clinical Data Strategist & Innovation Lead, Sensan Bio

Session Details:

Clinical data management innovation in practice: AI, analytics, and strategic partnerships across sponsors & CROs

2026-09-09, 11:15 AM

Session Details:

PANEL The Future of Clinical Data Management: Trends, Technology, and What’s Next

2026-09-09, 9:00 AM

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Satish Dachepally
Director of Clinical Database Programming, Incyte

Satish Dachepally is an Executive Director at Incyte Corporation focusing on Clinical Data Management areas. Satish has over 20 years of success in overseeing the collection, analysis, and reporting of clinical trial data.  He is adept at implementing industry standards and best practices, including CDISC SDTM and CDASH to ensure data integrity, compliance, and streamlined processes.  He is dedicated leader passionate about advancing clinical research through robust data management practices.  He made significant contributions to successful approval of multiple marketed drugs across diverse indications.  Satish earned a Master of Science degree from United Kingdom.

Session Details:

ASK THE EXPERTS PANEL What are the biggest challenges in data management right now and what can I do to prevent roadblocks in study timelines?

2026-09-09, 4:45 PM

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Sriram Krishnamurthy
Director- Global Development – IT, Regeneron

As a technology leader and life sciences domain expert, Sriram brings in a unique blend of management capability, end-to-end delivery expertise, consulting, architectural, and analytical skills. His areas of expertise include data science, machine learning, deep learning, big data, cloud services, behavioral sciences, business analytics, predictive analytics, data warehousing, business intelligence, and data management. He specializes in clinical systems, commercial operations, and digital marketing.

Session Details:

SESSION TITLE TBC

2026-09-10, 4:00 PM

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Stephen Duprez
Director, Clinical Data Management, CorMedix Therapeutics

Lead project management, monitoring and data management initiatives for 500 projects, using expertise in leadership, analysis, evaluation, resource requirements, and technical tools to increase productivity, and to proactively create contingency plans that resolve significant issues. Extensive global leadership for 80 Biometric professions in the processing of large multi-central trials that achieved NDA/MAA submissions/approvals and post approval requirements, while managing Biometrics department P&L. Key strength areas include: DATA MANAGEMENT | PLANNING | METHODOLOGY EVALUATION | TECHNICAL | GLOBAL TEAM LEADERSHIP | DASHBOARD DEVELOPMENT | CROSS-FUNCTIONAL TEAMS | SOP DEVELOPMENT

Session Details:

ASK THE EXPERTS PANEL What are the biggest challenges in data management right now and what can I do to prevent roadblocks in study timelines?

2026-09-09, 4:45 PM

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Sumita De
Director, Data Enablement - Head of Integrations, Regeneron

Strategic leader with 20+ years in global drug development, driving data governance, AI innovation, and clinical transformation. I specialize in delivering scalable clinical applications and integrated data solutions that strengthen quality, compliance, and operational efficiency across GxP and non‑GxP domains. I’m known for building connected clinical ecosystems, mentoring cross‑functional teams, and aligning digital strategies with real patient impact. My leadership style blends clarity, calm authority, and emotionally intelligent decision‑making — especially in complex, high‑visibility environments. I’ve managed and mentored global teams to deliver multiple large‑scale digital initiatives, modernize clinical data flows, and enable automation that reduces operational burden. I’m focused on roles where I can shape strategy, own domains, and advance healthcare through analytics, automation, and thoughtful, human‑centered leadership.

Session Details:

How to outsource in clinical data management effectively: Governance, quality, and control without losing speed

2026-09-09, 4:15 PM

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