09.00 Open Remarks from the Chairperson

Charlie Xu
Vice President
FRONTAGE CLINICAL SERVICES

09.10 Overcoming the Data Challenges in Multi-Center Clinical Trial Operations - Data Transmission and Integration to Meet International Regulatory Standards

• Understanding the benchmarks in patient recruitment and data entry
• Building a single data management platform
• Proposed solutions for improving security in data transmission

Xu LieDong
Director, Data Management, R&D Beijing Hub
MERCK SERONO CHINA

09:50 The Best-Practice Case In The Offshoring Of Statistical Programming: Important Points to Consider When Offshoring Statistical Programming

• Assessing the position that offshoring is essential to gain access to a wider talent pool
• Appreciating the pros and c ons of offshoring: potential cost savings vs. oversight, training etc.
• Exploring the best offshoring model for your business
• Understanding that an offshored workload has to be truly transactional to obviate large hidden costs
• Keeping an eye on the economic variables: inflation, turnover and productivity
• Considering the case for automation of transactional activities rather than offshoring

Deng YaZhong
Head of CDARO China
COVANCE

11:00 Using Informatics to Overcome Data Analysis Bottlenecks, Streamline Processes and Improve Innovation through Reduced Analysis Time

• Processes and workflows to maximise efficiency and reduce the time taken to generate meaningful results from high throughput data
• Automating processes and work flows, integrating them to into one single step combining data preprocessing, quality control and feature selection
• Development of a ‘one-stop’ exploratory analysis workflow that reduces analysis time from days to minutes
• Implementation of a classification pipeline that incorporates all classification steps into a single pipeline covering initial data filtering, feature selection, classification, and evaluation of the results

Mrunalini Jagtap
CCDM, PMP, Assistant Manager (CDM)
WOCKHARDT

11:40 PANEL DISCUSSION : Maximising Trial Efficiency by Effectively Integrating Data into One Platform

• Discussing challenges of data integration across the clinical data lifecycle
• Sharing, managing, analysing and integrating varied and increasing sources of data
• Debating interoperability between different systems

Moderator:

Charlie Xu
Vice President
FRONTAGE CLINICAL SERVICES

Panellists:

13:20 PANEL DISCUSSION : Overcoming the Most Common Challenges Facing Clinical Data and Information Integration

• Understanding that replacing paper with electronic systems is the catalyst for demanding seamless data interchange between laboratory and other business systems
• Understanding how business and scientific demands are driving requirements for integration
• Outlining the technical barriers and constraints that challenge a way forward
• Raising questions about the available resources, knowledge and skills required to progress

Moderator:

Charlie Xu
Vice President
FRONTAGE CLINICAL SERVICES

Panellists:

14:00 Optimising The Sponsor-CRO Relationship

• Assessing the factors that influence pharmaceutical research sponsors in their selection and retention of contract research vendors and partners
• Exploring the full project to the full function/task outsourcing continuum
• Understanding the type of sponsor project manager would serve each outsourcing “style” best?
• Data flow vs. data quality reports: examining score-cards, performance evaluators and due diligence
• Specialised procedures, central readers/adjudication committees, central laboratory and whether it is project or functional outsourcing?
• Appreciating the crucial need for standardising template contract agreements and benchmarking partners vs. in-sourced activities

Charlie Chen
Vice President
GCP CLINPLUS

14:40 Minimising Mistakes and Fraud Prevention in Data Collection and Management

• Understand the Good Clinical Practice (GCP) of audit process
• Ensure that your data and supporting documentation are accurate and presentable for inspection
• Gain knowledge concerning common outcomes and ��indings in clinical trials
• Understand how to respond to an audit to avoid further regulatory consequences
• Learn how to detect and prevent fraud and mistakes in clinical trials data
• Fully understand the consequences which result when proper procedures are not followed

Charlie Xu
Vice President
FRONTAGE CLINICAL SERVICES

15:30 Offshoring in Data Management to Reduce Cost and Improve Productivity – Case Study in Supporting an Operation in Japan

• Establishing an offshore location in China to support Data Management activities from Japan
• Requirements for different project team model
• Challenges and benefits of managing such an offshoring operation including cultural differences, communication, quality, and staff training & retention.
• How offshoring from Japan can be successful and continue to grow to mirror the success of countries such as India

Sun HuaLong
Manager GRO, Data Processing
PAREXEL

16:30 Data Transmission and Safety Considerations

• Regional and global regulatory requirements for secure data transmission
• Strategies in reducing data transmission time through global multicenter cooperation
• Data safety solutions

Charles Yan
Senior Director, Clinical Data Management
SHANGHAI CLINICAL RESEARCH CENTRE

17:10 Closing Remark from the Chairperson

17:20 End of Conference