1. Clarify the importance of the data management process and its crucial contribution to the clinical trial.
2. Provide the basis for their participation in submission-oriented clinical trials. 
   The seminar will provide a detailed discussion of the elements involved in the implementation and management of clinical data as well as a presentation of the regulatory requirements and the accepted ways of answering and handling these requirements successfully.

• Gain an understanding of the data management process in clinical trials
• Learn basic “do’s and don’ts” during clinical data collection
• Acquire tools for the design of a reliable, accurate and clean database

• Case Report Form (CRF) design and completion guidelines
• Database structures
• Development of the data management plan (DMP) and guidelines
• Data capture techniques
• Traditional (paper)
• Electronic Data Capture: The Emerging Clinical Data Management Standard
• Data Management Validation (DMV)
• Edit checks/queries generation and resolution
• Validation and quality assurance processes
• Audit trail/change control
• Database lock
• Storage and recreation of clinical data
• Introduction to regulatory requirements: ICH and FDA guidance
• Introduction to CDISC Standards Relevant to e-Clinical Trials

• People involved with clinical trial data 
• Professionals responsible for clinical data management and reporting 
• Project managers and statisticians involved in data management and monitoring processes  
• QA people and managers
• Regulatory Affairs people and managers

Tali Azulay, Clinical Data Management, senior consultant of Bioforum. Tali holds an M.A. in Experimental Psychology from Bar Ilan University, and B.A. in Psychology from Ludwig-Maximilians University, Munich, Germany. Tali has extensive experience in the data management of phase I to IV studies and the preparation of SOPs for the data management process

Paul A. Bleicher, MD, PhD, serves as Chairman and Founder of Phase Forward, which he helped grow from a concept to its position as a leading provider of clinical trial data management and drug safety software to the drug and device development organizations as well as academic medical centers. Prior to Phase Forward, Dr. Bleicher served as Vice President of Clinical Affairs for Alpha-Beta Technology, where he was responsible for Phase I through III clinical development of a novel carbohydrate drug. He previously served as a Medical Director for PAREXEL International, where he created and headed the Early Phase Services Department, assisting pharmaceutical and biotechnology companies with the initial development of novel therapies. Dr. Bleicher writes a regular column on technology in Applied Clinical Trials, and serves on the editorial boards of Applied Clinical Trials , Drug Information Journal, and Research Practitioner. He has served on the DIA Board of Directors, chaired the Steering Committee of North America, and served on the DIA Foundation Board. He is a member of the Dean’s Advisory Council, School of Science, Rensselaer Polytechnic Institute. In 2002, he won the Ernst and Young Entrepreneur of the Year Award in New England. He was recognized by PharmaVoice as one of the 100 Most Inspiring People In The Life Science Industry and was recognized by the Boston Business Journal as a “Champion of Healthcare” in 2006. Dr. Bleicher earned his BS from Rensselaer Polytechnic Institute, and his MD and PhD from the University of Rochester School of Medicine and Dentistry. He trained in Internal Medicine at the Beth Israel Hospital and in Dermatology at Harvard Medical School/ Massachusetts General Hospital. He was a post-doctoral fellow at the Dana Farber Cancer Institute and began his career as a physician/investigator at the Massachusetts General Hospital and Harvard Medical School.