Outsourcing in Clinical Trials China 2025

The launch of Outsourcing and Clinical Trials China is your opportunity to engage with the forefront of clinical trial innovation in one of the fastest-growing markets for clinical research.

3 - 4

September

2025

suzhou, China
Ticketed

Why attend?

Why attend?

The launch of Outsourcing and Clinical Trials China is your opportunity to engage with the forefront of clinical trial innovation in one of the fastest-growing markets for clinical research. Here’s why you should attend:

Access Local Expertise: Gain insights into the unique challenges and opportunities within China’s clinical trials landscape, directly from local and international experts.
Regulatory Updates: Stay ahead with the latest regulatory developments and compliance strategies essential for navigating China’s evolving healthcare environment.
Industry Networking: Build meaningful connections with leading CROs, biopharmaceutical companies, and other stakeholders driving clinical trial success in China.
Strategic Collaboration: Explore strategies to optimize outsourcing partnerships and discover tailored solutions for managing clinical trial operations in a complex, dynamic market.
Emerging Trends: Delve into cutting-edge technologies and methodologies shaping the future of clinical trials in China, from digital tools to innovative supply chain solutions.

Agenda

3 Sep 2025
4 Sep 2025

Expand All

8 AM

Registration and refreshments

8:40 AM

Chairperson’s opening remarks

8:45 AM

The Biotech’s Gambit: Key considerations to identify right CRO/vendor partners

• What is vital for a biotech in CRO/vendor selection?
• As a biotech, who is a good partner? A small/medium-sized CRO or large global CRO?
• How can a biotech engage a CRO to prioritize its study?

9:15 AM

Beyond Excel: Innovative Solutions for Clinical Supply Forecasting & Planning

• Identify critical areas often overlooked in clinical supply chains that lead to inefficiencies
• Explore the benefits and limitations of each type of tool: from excel-based to specialized forecasting tools dedicated to the clinical supply chain
• Gain practical insights from case studies that explore complex trial designs, waste management, monitoring processes, and adaptability to changes

9:45 AM

ICH E6R3 – What we need to know and do to optimize trial management

• Familiarize with the major revisions and updates in ICH E6R3 guidelines compared to previous versions
• Adopt standardized documentation practices to ensure consistency and compliance with ICH E6R3
• Training and Capacity Building

10:15 AM

Post-pandemic: Strategies to advance your journey in vaccine development

Trend of vaccine trials landscape
Leveraging Southeast Asia in vaccine development
Case study on expediting clinical development in a multi-regional vaccine study

10:45 AM

Morning refreshments and networking – Please visit 3 booths in this break

STREAM A: Outsourcing & Clinical Operations

11:30 AM

Why Patient Access Matters – From Korea Perspective

• Where Korea stands from Global view
• Country Allocation, and Site Selections
• New ways of recruitments

12 PM

Australia, your springboard for early phase clinical development

• Clinical Trial Ecosystem in Australia
• Regulatory Requirements in Australia vs USA
• Case studies : FIH Studies Robotic Pill and Vaccine Programs

12:30 PM

Using AI (Artificial Intelligence) in Drug Discovery and Development

Using AI model to discovery Hit (Virtual Screening, Docking, MD simulation)
Implement machine learning models to predict biological activity and optimize lead compounds

1 PM

Lunch and networking – Please visit 3 booths in this break

2:15 PM

Four essential factors for success in your Oncology trials

• Why biomarker-driven study is needed
• Development strategy using single-arm trial for rare disease
• What is important for a successful phase 1 clinical trial?
• How to improve the data quality of complex structures

2:45 PM

Guiding Principles for Effective Global RTSM Solution Deployment

• Strategic Planning for New Technology Adoption: Key factors to consider for effective integration in evolving business regions
• Enabling Efficient and Reliable Clinical Trials: Best practices to ensure trials are fast, compliant, and well-supported
• Leveraging Global Experience for Success: Real-world insights to navigate complexities and enhance outcomes locally and internationally.
• Preparing for Future Market Demands: Forward-thinking strategies for seamless integration and adaptability

3:15 PM

FIRESITE CHAT: Overcoming challenges in CRO and site management to enhance success in your trials

• Successful cases of collaboration with CROs that led to a positive impact on clinical trials
• The key element when beginning a partnership with a CRO
• The approach to handling and resolving issues when they arise

3:45 PM

Afternoon refreshments and networking – Please visit 3 booths in this break

4:30 PM

The advantages and hurdles of Risk-Based Monitoring frameworks in clinical trials

Exploring how risk-based monitoring improves resource allocation by minimizing on-site monitoring visits
How can clinical teams step back and self-analyse what risk could occur rather than rush straight in?
Choosing the correct RBM strategy to apply to your trial to reduce the time to approval for INDs

5 PM

PANEL DISCUSSION: Deep dive into the industry landscape with a focus on current challenges

• The impact of the medical strike on your trials
• Regulatory and compliance; Whats new?
• Data integrity and management challenges
• Financial and operational efficiency; How to reduce costs and timelines

5:30 PM

Chairperson’s closing remarks

8:30 AM

Registration and refreshments

9:10 AM

Chairperson’s opening remarks

STREAM A: Outsourcing & Clinical Operations

9:15 AM

THINK TANK: Clinical Vendor Quality Management – A Sponsor’s Perspective

• Establish quality benchmarks and standards to ensure vendors meet the specific needs of clinical trial protocols
• Conduct regular audits, reviews, and KPI assessments to track vendor performance
• Validate vendor adherence to regulations to minimize risks and preserve the integrity of data

10:15 AM

FIRESITE CHAT: Vendor Selection Strategies: Building knowledge for optimal decision-making

Clearly define requirements to outline specific needs and expectations
Evaluate Cost vs. Value: Look beyond price

10:45 AM

Morning refreshments and networking – Please visit 3 booths in this break

11:45 AM

Achieving successful trial outsourcing from the perspective of small biotech companies

• As a small biotech, is it beneficial to work with a smaller CRO or a large global CRO?
• Addressing clinical development planning and strategic decision making with limited resources
• Overcoming hurdles and sharing best practice to successfully outsource trial

12:15 PM

PANEL DISCUSSION: Setting up global clinical Trials, with a focus on Asia Pacific

• Opportunities and challenges of conducting clinical trials in Asia: Benefits and factors to consider when selecting Asian nations as trial locations
• How different notified bodies and their regulations present challenges to our clinical execution strategies
• Grasping the distinct regulatory frameworks and prerequisites for clinical trials

1 PM

Lunch and networking – Please visit 3 booths in this break

2:15 PM

Prize Draw

Join us for a chance to win one of our prizes, including Technology products

2:30 PM

WHO’s 2024 clinical trial guidance: what do I need to know?

Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

3 PM

Speaker Hosted Roundtables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Roundtable session lasts for 30 minutes and rotate

ROUNDTABLE 1: What key aspects of inspection readiness should we be considering right now?

Sukyoung Kwon, Head of Clinical Operation, Taejoon Pharm

ROUNDTABLE 2: Getting the best out of your sponsor – CRO partnership

Dayeon Ko, Director of Clinical development, Enzychem Lifesciences

3:30 PM

Chairperson’s closing remarks

END OF CONFERENCE

OCT Advisory Board

Select a member to learn more

Back

Rosalie Filling

Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

Back

Kathleen Cohen

Vice President, Clinical Development, Marinus Pharmaceuticals

Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals. Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

Back

THOMAS M TREMBLAY

Vice President Of Clinical Development, Trefoil Therapeutics, Inc

Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

Back

Behtash Bahador

Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Back

Bao

Vendor Engagement and Business Operations Leader | Strategic Advisor | Clinical Data Management Expert

With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

Plan Your Visit

Venue

Arena International Events Group “(Arena”) is aware of numerous third party agencies which are contacting Arena’s customers and purporting to have access to hotel room bookings and events attendee lists. For the avoidance of doubt, Arena will only share attendee lists with carefully selected third party partners for event registration purposes. Whilst Arena International Events Group pursues third party agencies for their potentially illicit activity, Arena encourages you to be cautious in engaging with such third party agencies and Arena shall not accept any responsibility for any losses incurred by you should you choose to engage with third parties that have no affiliation to Arena International Events Group.

Why partner?

Contact us to become a partner

Partnership Opportunities

We work with you to design a bespoke package to meet your business needs, where you could:

Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking