While Our Heritage is in OTC Switch, PEGUS Does Much More – We’re Skilled in Clinical Trials

PEGUS Research is a highly innovative Contract Research Organization (CRO) based in Salt Lake City, Utah. We’ve served clients’ research needs for more than 34 years and have extensive experience working directly with clinical sites (including physicians from various specialties), pharmacy sites, patients, consumers, and the FDA. While most of our work is in the US, we’ve also conducted successful studies in Europe leading to regulatory approvals. We welcome an opportunity to talk with you about your traditional randomized clinical trial needs.

We’re Experts in Innovative Decentralized Research

In March 2020, FDA Released Guidance on Clinical Trials During the COVID-19 Pandemic describing alternative methods for assessments (phone, virtual, and alternative locations), the use of e-consent, and distributing investigational products via alternative secure delivery methods. Then, in May 2023, FDA issued Draft Guidance on Decentralized Clinical Trials describing elements such as:

• Using digital health technologies (DHT)
• Making trials diverse and inclusive
• Bringing activities to participants’ homes and reducing the need for travel
• Delegation of responsibilities to local HCPs
• Utilizing remote visits and direct distribution of investigational product (IP)
• Hybrid designs
• Remote monitoring

In many cases, remote or decentralized trials can offer significant advantages over traditional site-based trials because they remove geographic constraints, allow broader representation (with more diverse samples drawn from across the entire US, for example, rather than only areas connected to physical sites), make study visits and other assessments less burdensome for participants, and ultimately save cost and time for sponsors.

At PEGUS we are highly skilled in designing and conducting studies that allow patients or consumers to participate from their homes or wherever they happen to be. We have conducted dozens of “decentralized” studies using these tools:

• PEGUS in-House Principal Investigator (physician) and Coordinators (registered nurses)
• Digital/social media and traditional media recruiting Campaigns
• Study-specific landing pages, online prescreening forms, and appointment scheduling systems
• Robust eConsent
• Self-administered enrollment, e-diary and ePRO assessments
• Telemedicine data collection and adverse event evaluation interviews
• In-house investigational product storage and direct-to-patient/consumer distribution

In-House Functions Including:

• Study design consulting and protocol creation
• CRF and database design
• Investigator selection and management
• IRB submissions
• 21 CFR Part 11-compliant EDC, e-consent and ePRO platforms
• Real-time recruitment, enrollment and study milestone metrics
• Study monitoring and site auditing
• Data management
• Medical monitor/adverse event evaluation
• Statistical programming (tables, figures, listings)
• CDISC submission ready data
• Medical writing/clinical study report

We Are:

• Highly attuned to FDA requirements
• Robust in SOPs and GCP compliance
• Transparent, responsive, and client focused
• Adaptable
• Timeline driven
• Rigorous in privacy/security (including external audits)
• Successful in FDA audits