Worldwide Clinical Trials has customized phase IIB-IIIB clinical trial services, which can be deployed on a stand-alone basis or as a full-service solution, creating scalable, flexible programs based on experiences with other programs ― across therapeutic areas—that help avoid pitfalls. Phase II-IIIB is often scrutinized for opportunities to shorten timelines or reduce levels of investment by dosing across the fewest number of patients with disease characteristics to optimize signal detection. Proceeding with Phase II programs that neither define a clinically useful dose range nor patient characteristics predictive of response enhances the possibility of Phase III failure.
We counsel in both regards ― leveraging experience with comparable challenges. In a quest to introduce patient populations who are more representative of those intended for marketing, exclusions in Phase III trials should be closely examined and carefully justified. There are powerful reasons to enroll more representative patient samples, to facilitate better estimates of efficacy and safety across treatment settings.
Planning Early for Market Success
The planning process for commercialization now begins in the early stages of most clinical investigations. We can help you supplement or complete trials to better define product characteristics, investigate quality of life or healthcare utilization issues, explore marketing strategies which acknowledge differences in standards of care internationally, or plan for Phase IV evaluations which are either mandated as part of post-marketing commitments, or envisioned as part of a line extension.
Global Experience, Local Expertise
In today’s highly international clinical trial environment, an ability to use regional differences in standard of care and thus improve patient access to clinical trials is an asset for any CRO. Because of our highly differentiated geographical footprint, characterized by “in country” clinical experts who are familiar with language, culture, and standards of care, our ability to operationalize clinical studies for “difficult to find, difficult to treat patients” is exceptional.