PHASTAR West Coast – Six Month Update

PHASTAR's San Diego office, our third in the US, just passed its six-month 'anniversary'. This office was set up to serve as a strategic operations hub for PHASTAR, further supporting our west coast sponsors and is a key component of our five-year plan. It has been an exciting, busy, and challenging year thus far – COVID-19 has modified our working world, and we continue to focus on thriving during these uncertain times. 

I joined the PHASTAR team to open the San Diego office, focusing on all aspects of PHASTAR’s strategies including business development, developing proposal and processes for delivery of clinical trial projects, staff development and recruitment. I also manage senior technical staff and am involved in oversight of multiple projects to ensure clinical trial reporting is delivered to agreed timelines with optimal quality.

Despite starting the San Diego office during the COVID-19 pandemic, the past six months have been incredibly productive and rewarding. I had the unique opportunity to serve as a statistical consultant on several technical projects, provide time-sensitive input on trial design and statistical considerations on COVID-19 trials, assist in candidate selection for the PHASTAR graduate program in the US, develop business proposals supporting clinical trials in multiple therapeutic areas, and lead ongoing clinical trial projects. Additionally, I had the opportunity to deliver an external seminar on 'Ideas and Trends in Real-World Evidence from a Regulatory Perspective', as well as presenting on 'Ordinal Endpoints in Clinical Trials' at PHASTAR’s inaugural Life Science Summit, which saw over 400 people from >40 countries join us for two days of exciting and engaging discussions on statistics in clinical trials and data science.

Of course, one of the biggest challenges of 2020 has been the COVID-19 pandemic, which affected nearly all ongoing and planned clinical trials globally. To account for necessary changes in patient visits, we worked with clients to rapidly adapt and amend existing clinical protocols and data collection forms to accommodate alternative patient assessments and data collection. Several trials were temporarily halted or delayed as to primarily reduce the risk of SARS-CoV-2 infection to patients and research staff. Modifications to statistical analysis plans were also necessary to properly account for COVID-19 associated events and missing data patterns. The past six months have certainly illustrated the importance of teamwork and flexibility while highlighting the feasibility of more-flexible (e.g. virtual patient visits, remote data collection, etc.), parsimonious, and rapid (e.g. master-protocol designs) clinical trials. The future of clinical trial designs will likely look different in part due to this pandemic. At PHASTAR, we continue to prioritise COVID-19 trials and continue to support sponsors with modifications to their trials and help with rapid database development, efficient trial design and ongoing communications with regulatory agencies.

The west coast can be a challenging, competitive environment for CROs, and access to local, 'on the ground' experienced providers is becoming increasingly important to pharmaceutical/biotechnology sponsors. PHASTAR’s award-winning services in statistical consulting, clinical trial reporting, data management and data science, underpinned by 3,700 years combined technical experience is perfectly placed to support the US west coast's eclectic mix of pharmaceutical, biotechnology and medical device companies.