Planning and Key Considerations for Global Studies

In recent years, the proportion of clinical trials conducted in more than one country has risen rapidly;  as many as  65% of all clinical trials could be conducted globally in the next 2-3 years. Rising costs of drug development in the United States, increased complexity in clinical trial requirements, and competition for eligible patients are all factors influencing the industry-wide increase in global clinical trials.

After completing the course, you will be able to:

1. Describe ClearTrial features that support global study planning
2. Model a complex global study in ClearTrial using the following features:

•   Currency exchange rates
•   Modeling and reporting in different currencies
•   Location-specific Site Approval Schedules
•   Location-specific FSI dates and Subject Enrollment Schedules
•   Adjusting decentralized labor hours and costs globally and by region
•   Global and location-specific Pass-Through Cost modification

The course is intended for clinical and financial professionals with at least three months’ experience (on a regular basis) with the ClearTrial software.

Prerequisite: 100-PLN1