Daily Operations and COVID-19 Trials
Ensuring the health and safety of our study volunteers and site staff is essential to continuing conduction of clinical trials. While COVID-19 vaccinations have recently started in Japan, we have been actively conducting PCR/TMA tests to detect SARS-Cov-2 infection for our study participants and staff. Taking basic infection-control measures (ex. Mandatory masks, social distancing, frequent hand washing, increased ventilation, etc.), ALL SOUSEIKAI sites are now able to operate at full capacity.
Encouraged by PMDA’s favorable regulatory treatment of the shorter (< 30 days) CTN timeline to start clinical trials of candidate products for COVID-19 (https://www.pmda.go.jp/english/int-activities/0001.pdf), and free scientific advice for COVID-19 vaccine development (https://www.pmda.go.jp/english/int-activities/0007.pdf), we have been involved in clinical studies of novel/repurposed treatments and vaccines since the current pandemic started. What’s more, the flexibility of our IRB meetings allow them to be held in exceptional ways, such as via online meeting, in accordance with recent MHLW requests (https://www.pmda.go.jp/english/int-activities/0002.pdf).
As safe and effective vaccine development has been the focus of public attention, we have received much positive attention from the media by way of TV interviews (https://souseikaiglobal.com/interview2020.php). Although expectations and accompanying pressures on us are high, we are proud to be contributing to the positive resolution of this global pandemic.