MUMBAI, INDIA, June 15-With over 3,700 patients enrolled in its large-scale Covid-19 drug trial in less than five weeks, the Serum Institute of India may well have set a speed and agility record in vaccine clinical trials in the battle to prevent or mitigate the impact of Covid-19. Serum Institute of India (SII), the world's largest manufacturer of vaccines by number of doses produced and sold globally, is testing rBCG vaccine, a tuberculosis vaccine typically administered at birth, to determine its ability to reduce the severity and incidence of Covid-19 infections among high-risk patients.

More than 6000 high-risk healthcare professionals currently working with Covid-19 patients and other high risk individuals are being tested at 40 sites across India, all at a time when most clinical trial programs to an abruptly halted in response to the nation's current Corona-19 lockdown. Recruitment, enrolment and monitoring of trial patients has quickly been shifted from typical face-to-face visits to digital interaction, with multiple new software tools developed, tested and launched in three weeks.

New software platform include digital, "hands free" program enrolment and remote electronic "ePRO" or patient self-monitoring and reporting via smartphone, new cutting-edge technology developed by the Wide Angle-insight staff. Software developers also customized each specialist's view of the data, reflecting their unique professional requirements. The cloud-based system operates in real-time, and fully integrated to include eConsent, randomization, monitoring, safety management, data collection, risk management, medical monitoring, and analysis.

"We are proud to be at the forefront of this war against COVID. The clinical study that aims at reducing incidence & severity of COVID19 infections, has already enrolled over 3700 subjects so far in 5 weeks and we will soon complete enrolment of 6000 subjects. Our team has been able to dramatically shorten the timeline from approval to launch that is typically 8-10 weeks, and initiated the study in 40 sites across the India in less than 4 weeks from study concept, thanks to Wide-Angle-Insights." said Mr. Mandar Vaidya, Director Operations at DiagnoSearch, a contract research organization conducting the study.

"The unique study design and rapid execution by our team at Wide Angle Insights will help us speedily bring an effective solution to use if we see efficacy early enough during the trial," says SII Medical Director Hitt Sharma," adding "vaccinating and protecting 'first responders' and frontline workers throughout India and beyond is an urgent, high priority in the battle against Covid-19." He believes the speedy trial will accelerate the application to DCGI for marketing authorization."

"Serum Institute of India's confidence in our company has developed over years, allowing us to deploy our newly-developed cloud software platform at unbelievable speed at this time of crisis," Dr Ginde, Founder of Wide-Angle-Insights said, adding "The agility and flexibility of Wide-Angle-Insights platform, coupled with relentless efforts from our team and support from SII helped us to radically shorten the time by several weeks, hopefully helping us quickly and carefully bring a proven, effective solution to the people of India and beyond."