Korea's LSK Global PS, a clinical research organisation (CRO) will be monitoring the coronavirus vaccine trial data in Bangladesh.
The Sinovac Phase III Covid-19 vaccine trial will be primarily conducted by the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), an icddr,b official told The Business Standard on Friday night.
LSK Global PS would manage the trials remotely with non-contact interventions instead of taking the traditional site-centered approach, on the background of Covid-19 infection concerns, reports life science magazine the BioSpectrum Asia.
Clinical data will be sent directly to LSK Global PS's database and monitored remotely without investigators having to visit the site through the use of an e-source data management tool.
As per the company reports, the study will involve procedures, including pre-tests, informed consent, and administration of the vaccine, are carried out face-to-face while online tools and an electronic patient-reported outcomes (ePRO) solution will be used for additional informed consent and reporting of the participants' health conditions. The non-contact clinical trials are expected to generate a high-quality patient-centered clinical trial can be conducted with reduced cost and time.
The clinical trial will involve about 4,200 frontline healthcare workers at seven hospitals in Dhaka, Bangladesh.