Phase IV studies, or post-marketing studies are completed after the treatment has been brought to market to determine the effect of long-term use in a wide-range of patient populations. Erlanger Professor of Medical Research, Mayo Clinic; President and CEO, Resoundant, Inc. D., Musculoskeletal and Metabolic Imaging, Bio Telemetry Research - This webinar will take an in-depth look at CRO oversight and risk management best practice, delving into the gaps in oversight processes, the causes of these gaps and how to successfully address them Diane Beatty, Ph D, Managing Director, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences Jean Dehdashti, MSc, RAC, Scientist III, Regulatory Affairs & Product Development, Cardinal Health Regulatory Sciences - This series explores proven ways to develop go/no-go insights faster so clinical development teams can get submission-ready faster, reduce the risk of a rejected submission or potential market withdrawal, and optimize data provisioning, aggregation and review - Key elements of this webinar will include the importance of natural history information in rare disease research, the difference between registry and natural history studies, and how to design and conduct a registry or natural history study - The purpose of this webinar is to evaluate and discuss the methodological approaches outlined in the guidance and highlight several key areas that may warrant further consideration when designing and planning for such studies Dr. Henningfield, Ph D, Vice President, Research, Health Policy, Abuse Liability, Pinney Associates Dr. Heal, Ph D, DSc, FRSC, FBPh S, Executive Director, Rena Sci Ltd. Beatrice Setnik, Ph D, Vice President, Scientific Affairs, INC Research, Early Phase - This presentation will explore how exponential growth in the variety of real world data sources and their quick adoption across functional business units is necessitating the need for the standardization of real world data and analytics platforms - While PD-L1 by immunohistochemistry has been successfully employed as a companion diagnostic for several therapies across a handful of indications, PD-L1 is only one potential biomarker for showing a predictive response.There are a wide range of topics covered in our clinical trial webinars - from tips on clinical trial start-up and adaptive trials to risk-based monitoring and best practices for clinical trial enrollment. As more combination therapies are examined, more informative markers will need to guide when and how a treatment or combinations of treatment should be considered.The Microsoft Office Share Point Server, the server program component of the 2007 Microsoft Office system, is used by countless organizations to facilitate collaboration, manage content, and provide access to essential information.
Mc Garry Houghton, MD, Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center Joseph M. This webinar topic includes serialization, as well as additional measures that can be taken through global inspectors, overt and covert packaging modifications, and an emerging ability for authentication using cloud technologies and smart devices.
Beechem, Ph D, Senior Vice President of Research and Development, Nano String Technologies Alan B. - While PD-L1 by immunohistochemistry has been successfully employed as a companion diagnostic for several therapies across a handful of indications, PD-L1 is only one potential biomarker for showing a predictive response.
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Clinical trials are a group of biomedical or behavioral efficacy and safety studies, completed in humans, that are usually broken down in to four phases.