With COVID-19 unleashing catastrophe across the world, everyone is looking up to pharmaceutical companies to come up with a solution. Pharmaceutical companies are currently racing to create vaccines to slow down and potentially eradicate the ongoing pandemic. It is hard to remember when a progress of vaccine development made it to the news and to the speeches of political leaders.
With so much pressure on them, pharma companies need the best of the solutions to achieve this. There are many EDC platforms in the world today. However, when it comes to quick scale in clinical trials, many factors come into play and not many solutions are up for the challenge. Pharma and Contract Research Organizations (or CROs) need solutions that they can depend on.
How Clinion is Enabling CROs and Pharmaceutical Companies
Over the past six months, we have been actively reaching out to CROs and Pharmaceutical companies to offer our integrated solution. As we started enabling various COVID-19 vaccine and medicine studies, we started extending our learnings to other studies that started later.
We are currently:
- Helping 6 different companies conduct clinical trials for vaccines and medicines
- Helping these companies conduct more than 13 studies across the world
- Helping Bharath Biotech conduct their clinical trials for COVAXIN
- Setting up one study that comprises of more than 15,000 subjects
Key Reasons for Using Clinion for COVID-19 Studies
Here are some reasons why Bharat Biotech chose Clinion’s Integrated platform to manage their clinical trial studies.
Tried and Tested Solution
This is not the time for CROs to test new systems. With so much riding on their studies, CROs are looking for systems that are used by some major CROs in the market. Many leading CROs like JSS, CBCC, Clinnex etc., are using our solution. They have run numerous studies on our platform without a hitch.
These companies have found our solution scalable and robust enough to handle large study groups. Clinion product users find our platform intuitive and easy to learn and use.
This is probably the most important aspect of a COVID-19 study. Studies have gone live on our platform in just 10 days. Most platforms in the market today take at least 3 weeks or more to go live. We’ve helped our clients conduct more than 250+ studies on our platform. This experience has helped us create a platform that is easy to use, intuitive and can setup a study in a very short period.
CROs are looking for cost effective solutions. Our solution provides all the key components required for a COVID-19 study upfront as part of single license. We also provide multiple additional components that are tightly integrated with our platform. A CRO or a pharma company can pay and use only what they need.
Benefits of an Integrated Platform
CROs across India and outside have been using EDCs for clinical trials for a long time and are well of the various benefits of using one for their clinical trials. However, the benefits of an integrated platform are yet to be fully understood. Below are some of the benefits of having an integrated eClinical platform.
Integrated EDC & IWRS
Study randomization is a vital aspect of a clinical study. Clinion’s integrated IWRS solution can help set up complex randomization studies very quickly and with minimum effort. By integrating seamlessly with the EDC, data from EDC can be transferred to IWRS and vice versa in a safe and secure manner.
Integrated EDC & CTMS
CTMS brings out the true value of the study conducted, while giving the sponsors the ability to understand how the studies are being conducted. Our system is built to bring various data points like:
· Subject Recruitment Status
· Project Planning and Management
· Site Monitoring
· Document Management System
· Study Safety Reporting
By integrating CTMS with EDC, this information can be readily available. This can enable sponsors and CROs to view real-time study status, manage IP efficiently and manage project budgets and expenses efficiently among other things.
Integrated eConsent & eCOA
Subject Consent is a key regulatory requirement. By having a mobile app based eConsent form, CROs can onboard subjects virtually. This has come handy in many COVID-19 studies that have been conducted recently. Additionally, our eCOA allows remote collection of patient data using their own devices. The patient data is synched to the EDC for the site personnel to monitor and review.
While Indian Pharma companies and CROs do not have a dearth of talent to create a vaccine for COVID-19, they deserver all the help they can get from their IT partners.
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