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June 2 - August 18, 2017

Barnett International

10-Week Clinical Research Associate (CRA) On-Boarding Program

8:30 AM - 11:30 AM Eastern

The online 10-Week Clinical Research Associate (CRA) On-Boarding Program is appropriate for individuals with less than two years of experience as a CRA. The course provides practical, hands-on training as it relates to the CRA job function, and covers core sponsor and research site activities that promote the successful monitoring of studies for drug, biologic, and device trials. The course follows an ICH/ISO global GCP framework, and covers how to identify specific country requirements, making it appropriate for both U.S. and global audiences. Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lecture, case studies, and scenario review, as well as application-based homework assignments.


July 18, 2017

Barnett International

Writing Clinical Study Protocols

12:00 PM - 3:00 PM Eastern

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval.

July 19, 2017

Barnett International

Writing the Clinical Study Report

12:00 PM - 3:00 PM Eastern

The Clinical Study Report (CSR) is a critical document in the drug development and regulatory submission process. This web seminar presents the basic tools required to generate CSRs for the pharmaceutical industry. Participants will learn the elements of the CSR and the appendices, methods for turning the protocol and statistical outputs into one cohesive document, the basics of writing and preparing a document for submission, and the guidances to follow for reference.

July 20, 2017

Barnett International

Introduction to Clinical Research

1:00 PM - 2:30 PM Eastern

Have you ever wondered what clinical trials are and how they are conducted? This web seminar is designed to answer those basic questions. We will look at how drugs progress from discovery to testing in humans, and learn what it takes to obtain approval to treat a disease or condition. We will discuss the similarities and differences between drug and medical device development. Finally, we will review how Good Clinical Practice (GCP) is applied to clinical trials around the world and how it is designed to protect clinical trial participants and ensure that the information obtained during a clinical trial is accurate and reliable.

July 24, 2017

Barnett International

CMS-Medicare Coverage Analysis, Budgeting and Billing Compliance

10:00 AM - 11:30 AM Eastern

This web seminar is focused on processes and approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials. The ability to develop robust budgets, ensure billing compliance and adherence to CMS-Medicare regulations for clinical trials remains a challenge for many clinical sites, sponsors and Contract Research Organizations (CROs). A risk-based approach requires not only a strategy but tools to define key indicators to measure specific risks. In this web seminar, learners will come away with strategies for covering true costs related to clinical research and how to distinguish them from routine care charges. Methodologies to avoid false claims and/or wrongful billing will also be presented.

July 26, 2017

Barnett International

30-Hour Clinical Data Management On-Boarding Program

5:00 PM - 8:00 PM Eastern

The online 30-Hour Clinical Data Management On-Boarding Program is designed to provide a comprehensive and foundational study of the best practices which have been identified in the discipline of Clinical Data Management (CDM). From protocol review and identifying study design to the required data elements and the final steps at the milestone of database lock, we will identify and discuss crucial CDM processes. Information presented will give new Clinical Data Management personnel a robust view of all CDM processes. This on-boarding program will also assist individuals to refresh their knowledge if they are preparing to sit for the certification examination.

July 27, 2017

Barnett International

Monitoring Plan Development

1:00 PM - 3:00 PM Eastern

Although monitoring plans are not defined or specifically required by FDA regulations or the ICH GCP E6 Guideline, both organizations endorse the use of this tool in a Quality Systems management approach to clinical research. The traditional approach to monitoring plan development has relied upon reinforcing SOP-mandated monitoring activities with little focus on project and/or protocol-specific monitoring needs. This web seminar provides participants with concepts and templates to set up a monitoring plan that supports unique project risks and links to valuable data regarding investigative site and Clinical Research Associate (CRA) performance. Suggestions for development of monitoring plans for a risk-based approach to monitoring are also provided in this session.

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