Experienced Team Meets Accelerated Timeline in Global Phase 2B Study
March 10, 2015
BACKGROUND > PRC CLINICAL CHOSEN FOR GLOBAL PHASE 2 TRIAL OVERSIGHT, SITE MANAGEMENT AND MONITORING
PRC Clinical was awarded a global phase II clinical trial by an ALS-focused biotechnology company based in South San Francisco. The neurodegenerative disease study enrolled more than 700 patients in 73 clinical study sites across 8 countries.
PRC Clinical 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.
We were chosen based on our established relationship with the sponsor. They had successfully partnered with PRC Clinical in previous clinical projects, and trusted our experienced team could reach their goals.
CHALLENGE > COMPRESSED STUDY TIMELINE FOR DATABASE LOCK
The Sponsor faced challenges that lengthened enrollment time. Additionally, they shortened the initial timeline to complete patient enrollment and site visits and tasked PRC Clinical to deliver the clinical data weeks earlier than planned. The ALS-focused biotechnology company urgently needed the study results for a strategic presentation at the ANN (American Academy of Neurology) Conference.
PRC Clinical had to accelerate the completion of over 800 monitoring visits, and complete 80 visits in the last 30 days to meet the new timeline. PRC Clinical stepped up to reorganize patient timelines and site visits in this very short schedule.
SOLUTION > PRC RELIED ON EXPERIENCED TEAM TO MEET NEW DEADLINE
The project was a success thanks to the responsiveness, project management, and communication skills of the PRC Clinical team. Our highly experienced CRAs shifted their schedules and cooperated with the clinical sites in the field to meet the new deadline. The clinical data was delivered on time to the sponsor, enabling them to present the results at the conference.
PRC Clinical leveraged its cloud-based Clinical Trial Management System (CTMS) to centralize study conduct and track progress. Our cloud-based communications and reporting system provided real-time study status and metrics to the clinical study team to accelerate communication and increase productivity. PRC Clinical’s project managers submitted electronic monitoring ‘e-visit’ reports, which facilitated seamless communication between the field-based, regional CRAs, and project managers across global sites.
PRC CLINICAL CASE HISTORY > KEY HIGHLIGHTS
- Team of highly experience CRAs.
- Unmatched project management and communication skills.
- Efficient cloud-based Clinical Trial Management System (CTMS).