PPT-The IND and Clinical Trial Management

Frances Richmond Director International Center for Clinical Trials And you are The principal investigator of a companysponsored trial The principal investigator of an investigatorsponsored trial. QuesGen Systems was started with the mission of providing web-based data management for clinical research at a reasonable cost. . Clinical . Trial . Office:. S. upport . service for clinical trials . performed . using BMC clinical infrastructure. A . new . clinical research support service is being launched to . provide a central . Peter Sandercock. University of Edinburgh. ICTMC . Glasgow. 17. th. November 2015. My impression of ICTMC 2015. Lots of energetic and youthful folks. We . can. make trials more efficient. Need SWATS to improve trial methods. Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. David N. Assis, MD. Assistant Professor of Medicine. Yale University. I have no disclosures relevant to this presentation.. Clinical Trials in PSC. PSC is a rare disease . 32,000 patients in the US. PSC has no proven and approved treatment. Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. The Balance from . A Medical Communicator’s Perspective. 6th Asia-Pacific . Pharma. Congress. July 11-13, 2016 Kuala Lumpur, Malaysia. Dr.Namrata. Singh. Director - Medical Services. Turcaoz. Health Care Solutions. Trial . Office:. S. upport . service for clinical trials . performed . using BMC clinical infrastructure. A . new . clinical research support service is being launched to . provide a central . and comprehensive framework . T. he . trial sponsor . compiles . a detailed clinical study report (CSR. ) after each clinical trial. . This report follows . a format laid down by the regulatory . authorities.. The CSR can be hundreds of pages long.. “Putting it All Together. ”. 1. Why the changes to NIH-funded studies involving human subjects?. No policies existed to make sure that the public had access to results from unpublished NIH-funded research . Karen-Sue Carlson, MD, PhD. Associate Professor of Medicine. Division of Hematology and Oncology. Section Head and Medical Director of Acute Care. Medical College of Wisconsin. Milwaukee, WI. What are clinical trials?. PERFUSE Medical Research &. Clinical Trial Course. Clara Fitzgerald, MPH. The Importance of Clinical Trial Protocols. The Clinical Trial Protocol is the complete written description of, and scientific rational for clinical research studies. SESSION 8. Handout/Reference sheets:. Study Start-up. NIH guideline-study-start-up document. Study start-up Tips. SOP reference sheet from Session 9. Webinars:. Research 101, session 4. Research 102, session 4. Selvin Ohene. Director, Clinical Trial Office. . Financial . and Administrative Management of Research. Education and Training Program. October 21. , 2014. Goals of the presentation. 2. RESEARCH. vs. SOC.