Medical Writing


All biopharmaceutical companies must produce scientific reports and summary documents for regulatory agencies. Good documentation should be not only scientifically sound, but also clear, effective and concise. This course provides the practical skills needed to write effective documents for the healthcare industry. You'll gain practice through hands-on exercises and group projects based on documentation used in pharmaceutical development.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X413.(2) 6/15/2018 06:00 PM SANTA CLARA 750 David A West View Enroll

Clinical Project Management


This course addresses critical elements in the effective planning and management of clinical trials. Exercises and case studies illustrate how to develop and manage activities, timelines and budgets; examine staffing and resource requirements; and lead and motivate effective teams. Strategic development plans, team and site performance problems, and post-marketing studies are also discussed.

Prerequisites:


Offering code Offering title
REGL.X400 Good Manufacturing Practices
BTEC.X401 Drug Development Process
CTDM.X411 Good Clinical Practices

Clinical Data Management


High-quality clinical data are at the heart of a successful clinical trial. If the data are not complete or do not reflect the actual reported results, the analysis and the conclusions drawn from that analysis may not be reliable. This course provides clinical trial personnel a solid understanding of the steps involved in clinical data management from study site data collection through data extraction for analysis.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X400.(1) 4/26/2018 06:00 PM SANTA CLARA 825 View Enroll

Clinical Research: The Study Site Perspective


The conduct of clinical research requires effective working relationships between the study sites that execute clinical trials and the sponsors that design the trials and provide product for testing. This course offers practical insight into the clinical research process from the viewpoint of the study site. Lectures and class exercises explore the roles, responsibilities, interactions, and concerns of study site personnel and highlight important differences in perspective between clinical study sites and industry sponsors.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices

Clinical Trials Site Monitoring II


This course explores a range of approaches to monitoring clinical sites, the development of monitoring plans, and some of the more challenging aspects of monitoring clinical trials. Remote data entry, compliance audits, regulatory issues that arise in compliance audits, fraud and misconduct are also addressed. This course is designed for clinical research associates (CRAs) or those planning to become a CRA, clinical trial managers and clinical operations managers.


Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.




(2687)

Prerequisites:


Offering code Offering title
CTDM.X404 Clinical Trials Site Monitoring I

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X405.(1) 5/11/2018 05:00 PM SANTA CLARA 580 View Enroll

Contracting with Contract Research Organizations (CROs)


Pharmaceutical and biotechnology companies are more and more frequently using the services of contract research organizations (CROs) to access expertise or technology not available in-house for key clinical services in an effort to most effectively use limited resources. This course covers the identification, selection, and management of CROs in the performance of clinical projects.

Prerequisites:


No prerequisites


Document Preparation: Protocols, Reports, Summaries


Clinical trial documentation must be clear, scientifically sound, conform to regulations and established standard operating procedures, and follow regulatory guidelines. Despite pressure to start the trial "yesterday," a clinical trial cannot begin without a study protocol in place. Many other documents are needed before and during the trial, and the trial does not end until a final report has been submitted. Documentation of the trial often continues with articles in the biomedical literature.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X408.(1) 4/7/2018 08:30 AM SANTA CLARA 580 Romi Behbehanian View Enroll

Electronic Data Capture for Clinical Trials


A major trend among life science organizations has been the recent shift from manual, paper-based clinical data collection processes to the predominant use of electronic systems that expedite the availability of accurate clinical trial data. This course examines some of the key issues surrounding the industry's adoption of Electronic Data Capture (EDC) and gives students the opportunity to use EDC software on classroom computers during simulated clinical trials.

Prerequisites:


No prerequisites


Biology of Cancer


Understanding the molecular and cellular basis of cancer is essential for the development of new therapeutic strategies and diagnostic tools. This course explores the basic biology of cancer, including the key cellular processes and players, whose alteration leads to uncontrolled cell proliferation. Topics include the pathology and genetic basis of cancer, the immune system, and the role of infectious agents and environmental carcinogens in the disease process. You'll also discuss emerging therapies and strategies for cancer prevention.

Prerequisites:


Offering code Offering title
BTEC.X403 Cellular Biology

Viruses, Vaccines and Gene Therapy


The recent outbreaks of Zika and Ebola viruses and an increase in the rates of certain viral infections reflect the profound impact viruses have on human health worldwide. Students in the course study past viral pandemics—influenza, smallpox, and polio—and how they have altered human history. They survey how viruses replicate in human hosts and spread in human populations. Students also learn how recent developments in molecular biology and genetics have been instrumental to the biopharmaceutical industry in developing antiviral drugs and viral vaccines.

Prerequisites:


No prerequisites


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