Source: SAN FRANCISCO – BUSINESS WIRE
PRC Clinical™, a full-service Contract Research Organization (CRO) headquartered in the San Francisco Bay Area, today announced the completion of over 800 monitoring visits in a global Phase 2b neurodegenerative disease study. The study enrolled more than 700 patients in 73 clinical study sites across 8 countries.
The company provided dedicated trial oversight, site management and monitoring for 56 research centers in the US and Canada including global central laboratory services as well as physical and electronic platform trial master file support.
PRC Clinical has a strong record of study management execution proven to accelerate the timeline to database lock. The company’s cloud-based Clinical Trial Management System (CTMS) centralizes study conduct and tracking by providing real-time study status and metrics to the entire study team.
“This has been our largest monitoring effort to date and the successful study conduct was due to our extensive capabilities and significant experience in neurology. Our dedicated project managers and specialized teams submitted electronic monitoring ‘e-visit’ reports, which facilitated seamless communication between the field-based, regional CRAs and project managers across global sites. We are proud of our team’s accomplishment and remain dedicated to providing quality services and high sponsor satisfaction,” said Chief Executive Officer of PRC Clinical, Curtis Head.
PRC Clinical aggressively develops the most advanced tools for our team and sponsors realize the value of a secure, cloud-based CTMS that centralizes communication for the entire study. Accordingly, PRC has implemented customizable online monitoring reports that allow our staff to access study information, provide feedback and complete required reports within the integrity and quality built into the CTMS. The CTMS includes electronic site monitoring visit reports where regional teams, project managers, clinical staff and sponsors can draft, edit, review and finalize e-visit reports via secure electronic signatures which are CFR Part 11 compliant.
About PRC Clinical™
PRC Clinical™ is a full-service CRO headquartered in the San Francisco Bay Area with significant experience managing and supporting clinical programs for CNS and neurodegenerative disorders among others. PRC delivers the highest quality results in the industry, and offers the capabilities and expertise to handle the most complex clinical trials. PRC has served Sponsors in Phase I-IV clinical studies from niche and orphan drug trials to large clinical registries globally. We are therapeutically diverse and experienced with innovative treatment modalities from regenerative stem-cell technologies to cutting-edge medical devices. Services include clinical operations, project and site management, regional monitoring, data management & EDC, biostatistics, medical & safety monitoring, clinical payment services, CTMS, protocol design and development, IND preparation and filing, clinical laboratory services, medical writing, and consulting.
PRC Clinical —
Curtis Head, 877-519-6001