Utilizing a Collaborative Approach to Create Efficiencies with CDISC – CDASH Standards

Clinical Trials, Life Sciences,
  • November 19, 2015

Data accuracy is paramount to the success of a clinical trial, so why risk any inefficiencies? In this fast paced industry, where experts are constantly working to get drugs approved faster to improve the lives of patients, they sometimes forget to take a step back and analyze lessons learned to better improve their data standardization approaches.

This webinar will present to you a bird’s eye view highlighting a Phase I study with mid-level complexities. The webinar will showcase lessons learned from our own experience and highlight how building the database structure utilizing CDASH standards minimizes the gap with SDTM format.

Utilizing their own experience, as well as lessons learned from other colleagues, Jonathan and Yuguang will share their recommended approach based on best practices to create efficiencies between the Data Management and Stats / Programming teams. They will highlight ways to better understand the methodology from both team perspectives to achieve the goal of building a database for efficient data entry as seamlessly and error free as possible.

The key learning objectives for this webinar are to:

  • Understand the benefits of collaborating between Data Management and Stats / Programming teams to improve efficiencies.
  • Identify common pitfalls with data standards and discuss ways to improve them.
  • Learn why implementing a streamlined approach can create more efficiencies overall and how this can be substantiated.

Speakers

Jonathan Zimmerman, Senior Clinical Data Manager, FMD K&L Inc.

Jonathan Zimmerman is a Senior Clinical Data Manager at FMD K&L Inc. In this role, Mr. Zimmerman is the main point of contact for day to day activities for multiple studies with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to other study team members along with the appropriate documentation and execution throughout trial lifecycles.
He has been working in the Pharmaceutical industry since 2005. Prior to joining FMD K&L Inc. this year, he held multiple positions in Data Management at companies such as Covance, Clinical Development Services, Medidata Solutions, Inc., CoreLab Partners, Inc., and ICON Clinical Research, bringing with him a wealth of knowledge. Throughout his various roles, he has obtained experience in all aspects of clinical data management from study start-up to database locks covering clinical Phases I through IV. Additionally, he has experience in a wide range of therapeutic areas, such as oncology, cardiology, obesity, medical devices, and pain management. He earned his Bachelor of Arts and Science degree in Behavioral Biology from Johns Hopkins University.

Yuguang Zhao, MS, Vice President, Statistical Programming, FMD K&L Inc.

Yuguang Zhao is the Vice President of Statistical Programming at FMD K&L Inc. and serves as a member of the executive leadership team. In this role, Mr. Zhao is responsible for providing strategic planning and corporate direction for continued growth of the company, providing scientific leadership and resource planning for statistical support on all projects, and ensuring the teams provide high quality statistical programming support for Phase I, II, III, and IV clinical trials in the Pharmaceutical industry.
He has been working in the Pharmaceutical industry since 1997. Prior to joining FMD K&L Inc., he held a position at Eisai as Director of Global Statistical Analysis and before that served as Programming Therapeutic Area Head for Oncology at Sanofi. In these roles he has led different teams and has worked on many regulatory submissions such as NDAs / sNDAs.

Mr. Zhao has been very active in the industry working groups. He has co-led the CDISC / FDA data integration pilot as well as being a key contributor in the industry standardization efforts through his participation in CDISC SDS and ADaM working groups. He earned his Master of Science degree from the University of Nevada in the US and his Bachelor of Science degree from Inner Mongolia National University in China.

Who Should Attend?

This webinar is intended for biopharmaceutical professionals with roles in:

  • Clinical Data Management
  • Clinical Development
  • Biostatistics
  • Clinical Data Programming
  • Clinical Outsourcing
  • Clinical Trial Operations
  • Quality Assurance
  • Regulatory Affairs
  • Regulatory Operations
  • Clinical Data Standards

Xtalks Partners

FMD K&L Inc.

FMD K&L Inc. (formerly K&L Consulting Services, Inc.) is a Contract Research Organization (CRO) offering Data Management, Biostatistics, Statistical Programming, CDISC compliant eSubmission, Drug Safety, and Medical Writing services to the Pharmaceutical, biotechnology, and medical device industries worldwide. FMD K&L Inc. continuously strives to raise the standard of excellence through accuracy and consistency. This results in high quality output to get our client’s drug or medical product approved faster and to improve the lives of patients.

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