Problem Statement
In 2020, the global landscape changed dramatically with the advent of COVID-19. The fatal virus strain soon infected millions of people worldwide, forcing everyone to live a masked life that became limited to their homes.
Bharat Biotech is one of India’s leading Biotech companies and when India got hit by the COVID-19 pandemic, the company started looking for a proven and easy-to-use system that could accelerate COVID vaccine trials.
Bharat Biotech’s Covaxin, one of the first COVID-19 vaccines developed by an Indian company, was approved to enter Phase 1 and 2 of clinical trials by the Drugs Controller General of India in 2020. The company had very aggressive timelines to meet, and the Indian government, along with an entire nation, were eager to see how soon the vaccine could be tested and made available to the public. The studies were scheduled to go live in less than two weeks. The challenges were:
- Study set up Time frame
- Less time for training and onboarding
Bharat Biotech approached Clinion as they wanted a robust and easy to use platform which has a reputation for quick and seamless study setup without compromising on the quality and safety.
Solution
Clinion is a leading clinical trial technology provider offering the benefits of EDC, RTSM, CTSM, eCOA, medical coding and document automation in a single platform. Because of Clinion’s proven record of rapid deployment for even complex studies and very intuitive and easy to use interface, Clinion became the first choice for Bharat Biotech for its super critical Covid-19 phase I/II vaccine trials.
The Clinion EDC and RTSM were successfully deployed in the two-week time frame as requested by Bharat Biotech. Training the external CRO and Bharat Biotech’s internal operations and data management teams was also completed within the agreed timelines. FPI was achieved in less than three weeks from initiation, with minimal post production issues. Clinion ensured seamless integration between Clinion EDC & RTSM (Randomization & Trial Supply Management) to ensure reduced randomization and supply issues during this highly critical trial.
Achievements
Clinion enabled the very first COVID-19 Phase I/II study to go online and have the FPI in less than 3 weeks.
- The Clinion EDC and RTSM were successfully deployed in the two-week time frame as requested by Bharat Biotech.
- Clinion supported the trial which was spread across 3 phases
- Clinion also provided round-the-clock support to ensure smooth execution of the trials.
- The client was able to submit the data for interim analysis and approval and obtain approvals for phase III in less than 6 months from trial initiation.
The success of this study and the speed at which Clinion was able to set up and deploy the study encouraged Bharat Biotech to entrust six more vaccine studies to Clinion
Conclusion
Bharat Biotech was able to launch Covaxin during the pandemic within a year of starting the trials. The launch of Covaxin helped curb the impact of COVID-19 to a great extent.
Clinion stepped up to the need of the hour…. Clinion’s end-to-end integrated platform minimized manual labour and sped up the process. What takes 4-5 years of time, was accomplished in 1 year! Bharat Biotech partnered with Clinion and conducted more than 14 vaccine trials during the pandemic and after.
