For nearly 30 years, PEGUS has been a true innovator in OTC-switch research. The model we developed for pharmacy-based actual use research is now the industry standard. We continue to push the boundaries of new methods and technical tools to help solve complicated problems for innovative OTC candidates. Take a moment to explore our services and learn how we can help with your individual OTC program needs.:
Supporting Research Services
Pharmacy Site Network
PEGUS pioneered the use of pharmacy sites for OTC switch over 20 years ago. Since that time, we have developed a robust network of more than 150 sites around the US with trained, experienced pharmacist-investigators and study staff. Many of our pharmacist-investigators have participated in 5 or more actual use studies, making them a unique resource. No one has more experience adapting OTC consumer behavior research models and methods to pharmacy sites than we do. We also have experience selecting, training, and supporting pharmacy research sites in Europe.
In-House Call Center
PEGUS maintains a 20-seat in-house call center to manage inbound calls in response to OTC study recruitment campaigns. Our professional interviewers help manage preliminary qualification activities (participant screening), scheduling for study interviews, reminder calls, administration of telephone questionnaires and other subject-support related tasks.
We also maintain a talented team of registered nurses (10-15) for clinical data collection activities, such as periodic mid-study and end-of-study telephone assessments in actual use trials, adverse event collection, assessment and reporting, follow-up on pregnancies, and tasks related to eliciting medical condition and medication information from study participants.
We maintain a group of experienced in-house CRAs for site monitoring in our clinical studies, primarily actual use trials. PEGUS site monitors are carefully attuned to GCP and other requirements for ensuring the proper conduct and documentation of trials.
Our talented data management group programs, tests and maintains all our study databases in-house. We use a highly-flexible, 21 CFR Part 11-compliant electronic data capture (EDC) system as the foundation for all our study databases, and supplement this with e-diary, e-consent and various other subject-facing (ePRO) functionalities based on the unique requirements for each research program.
Statistics and Submission-Ready Data (CDISC)
PEGUS statisticians and SAS programmers manage the analysis and presentation of data for clinical study reports, including statistical analysis plans (SAPs), table shells, programming specifications, and the programming and validation of production tables, listings, and figures. They provide highly-capable, end-to-end services including programming and validation of CDISC, SDTM, and ADaM datasets, as well as reviewer’s guides and define.pdf or define.xml documents for submission to the FDA.