PRC Clinical Supports Australian Pharma to Run US Study
March 10, 2015
BACKGROUND > PRC CLINICAL AWARDED FULL-SERVICE PROJECT TO SUPPORT AUSTRALIAN PHARMA COMPANY
PRC Clinical provided full-service CRO support to Xenome, Brisbane-based Australian biotech company. Xenome initiated a Phase I clinical trial for 3 clinical sites of its lead drug candidate for neuropathic pain. Xenome is a biotechnology company focused on the discovery and development of peptide-based therapeutics.
CHALLENGE > PRC CLINICAL TO TRAIN SPONSOR AND MANAGE US TRIAL
The sponsor only had a “virtual” US presence and no experience in running US studies. The sponsor trusted PRC Clinical to guide them through the US regulatory process and train them to the specificities of US-led clinical trials.
PRC Clinical had to prepare training materials for the regional CRA team and Site Initiation Visits to support a very aggressive enrollment timeline. PRC Clinical was also tasked to source appropriate vendors for other areas of clinical support, including the central lab, drug packaging and storage needs.
SOLUTION > PRC CLINICAL BECOMES SPONSORS’ US PRESENCE AND PERFORM ONLINE TRAINING
Through its project office in San Bruno (CA), PRC Clinical became the US presence and provided the clinical Project Team to support the Sponsor’s Sr. Director in identifying and screening study sites, negotiating and executing site contracts and budgets, and collecting and storing regulatory documents.
With only two weeks to meet the enrollment goal of first-patient-in (FPI), PRC Clinical was able to prepare materials and carry out an Investigator Meeting by way of a webinar and also conduct physical Site Initiation Visits the very next day, with the FPI occurring on the following day.
PRC CLINICAL CASE HISTORY > KEY HIGHLIGHTS
- Strong regulatory knowledge.
- Strategic alliances to meet clients’ needs.
- Online remote training capabilities.