Rx-to-OTC Switch Services
At Concentrics, we have been industry leaders in Rx-to-OTC Switch for nearly 30 years. We have worked on 85% of the drugs and devices that have been successfully switched!
Clinical Services:
- Phase I trials (outpatient and exploratory, proof-of-concept)
- Phase II trials (dose ranging, safety, efficacy)
- Phase III trials (safety, efficacy)
- Phase IV trials (long term safety, claims, phase IV commitments, REMS, special populations, quality of life, patient reported outcomes)
Behavioral Testing Services:
- Self-Selection Trials (Self-Recognition, Self-Diagnosis, Self-Selection,)
- Actual Use Studies (Studies on All comers & Special Populations)
Regulated Healthcare Market Research Services:
- Label Design Consultation
- Label Comprehension Studies for OTC products (Drug Facts Labels)
- Patient Package Insert, Supplemental Materials Comprehension
- Consumer Insights Testing
At Concentrics, we offer the following services in our Rx-to-OTC Switch studies:
Consultation with Senior Consultants from the Concentrics Strategy Center
- Regulatory Strategy
- Switch Development Plan
- Study Design
- Protocol Development
Project Management
- Study Success Plan©
- Protocol refinement
- Questionnaire Development
- CRF Development
- Source Document Development
- IRB Submission
- Site Training
- Investigator Meetings
- Site Selection and Contracting
- Site Management
- Patient Recruitment
- Safety Surveillance
- Monitoring
Data Management, Statistics, Medical Writing
- Data Management Plan
- Programming/Edit Logic Checks
- CDISC data sets
- Double Data Entry and Reconciliation
- Query Resolution
- Adverse Event and Concomitant Medications Coding
- Data Analysis
- Statistical Analysis Plan
- Biostatistics
- Medical Writing/Report Writing