Observational research and labeling comprehension study experience
Disease Area | Sample | Product | Type of Research Study | Methodology |
Allergy | Patients and Parent Caregivers | Injectable Drug/ Device combination |
Observational study pre-market assessment of usability and attitudes towards a new drug delivery device |
One-on-one interviews |
Asthma | Patients and Parent Caregivers | Inhaled Drug/ Device combination |
Observational study and pre-market assessment on probable use patterns and attitudes towards new inhaler technology |
Web-based Survey |
Dermatology | Patients | Injectable Aesthetic | Observational study and pre-testing of a patient package insert for readability and comprehension |
One-on-one interviews |
Diabetes | Patients | Injectable Drug/ Device combination |
Observational periapproval study on product usability and comprehension of patient package insert |
One-on-one interviews |
Epilepsy | Patients and Parent Caregivers | Rectally administered Drug/Device combination | Observational periapproval study on product usability and comprehension of patient package insert | One-on-one interviews |
Epilepsy | Pharmacists | Rectally administered Drug/Device combination | Observational periapproval study on dose preparation and understanding of instructional materials | One-on-one interviews |
Epilepsy | Patients and Parent Caregivers | Rectally administered Drug/Device combination | Phase IV Patient Registry to measure pharmacy dispensing performance and patient understanding | Survey |
Gastro-esophageal Reflux (GERD) | Patients | Orally administered Drug capsule | Pre-Market Product Evaluation for new oral GERD medication including swallow test | One-on-one interviews |
Oncology | Patients | Injectable Drug/Device combination | Observational study and pre-testing of instrucrtions for use for readability and comprehension | One-on-one interviews |
Oncology | Patients | Injectable Drug/Device combination | Observational study and pre-testing of a Medication Guide for readability and comprehension | One-on-one interviews |
Pain | Patients | Inhaled medication | Observational periapproval study on product usability and comprehension of instructions for use | One-on-one interviews |