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