Rx-to-OTC Switch Services

1. At Concentrics, we have been working on switch studies for over 20 years. We have worked on 65% of the successful switch programs since 1995.

Clinical Services:

• Dose Ranging Studies
• Safety and Efficacy Trials

Behavioral Testing Services:

• Self-Selection Trials (Self-Recognition, Self-Diagnosis, Self-Selection, De-Selection)
• Actual Use Studies (Studies on Allcomers & Special Populations)

Healthcare Market Research Services:

• Label Design Consultation
• Label Comprehension Studies
• Patient Package Insert, Supplemental Materials Comprehension
• Consumer Insights Testing

As a value-added service to our clients, our internal Quality Assurance Department routinely audits our work to ensure quality excellence in the trial.

At Concentrics we offer the following services in our switch studies:

Design Team   •Research Design Consultation   •Protocol Development   •Switch Development Plan Project Management   •CRF Development   •Key Study Document and Tools Development   •IRB Submission   •Site Selection and Contracting   •Site Management   •Patient Recruitment   •Safety Surveillance   •Monitoring   •Questionnaire Development Data Management   •Double Data Entry and Reconciliation   •Edit and Logic Checks, Query Resolution, Adverse     Event and Concomitant Medications Coding   •Data Analysis and Biostatistics   •Medical Writing   •Report Writing