Drug trials, especially for biotechs can be challenging. You might not have enough know-how or assets to run efficient trials. And bigger CROs might not give the priority that you deserve. To top it all you want to execute the trial in a cost-effective manner.
A CRO designed for biotechs
Cost-effective trial execution leveraging onshore-offshore model, and Bangalore (India) location - potential for 40%-60% savings
Accelerated execution and seamless Scaling
Capabilities include Project Management, Study Setup, proprietary CRF Designer tool, Data Management & Statistical Analysis, Trial Management & Monitoring
Project management to keep your trial on track
Map out the trial timelines from the first patient in to database lock
Up to date on trial progress with a dedicated project manager
Real-time trial tracking and addressing trial issues as they happen with constant communication between stakeholders
Cost management to keep the trial on budget
Study setup. Protocol design, CRF design, and Study Build
We can help in proof-reading the protocol and making sure that it is programmable
We have templates that can get you started with CRF design in an efficient manner. We can also make sure that it is CDISC-compliant
Once CRFs are finalized, we can build up your study in a 2-3 week time frame (depending on the complexity of the study)
Use our proprietary CRF Designer tool to collaboratively design and finalize the CRF’s in accelerated fashion
Effortlessly design your study with our propreitary CRF Designer
With drag-and-drop functionality, it's easy enough for a project physician to design the CRFs!
Start off the trial right with CDISC-compliant CRFs
Share, collaborate, and finalize the CRFs
Share read-only versions of CRFs with the database programmer and trial sites.
Use the portal as a training tool for the CRAs and trial sites
Data management and Statistical analysis
This is the core of what we do, our goal is to get you submission-ready data from day one
We are EDC agnostic, we support all popular EDC systems (Medidata and Oracle Inform, etc)
We will set timelines for your project and stick to them - protocol finalization to first patient in, data cleaning metrics for sites, and finally last patient into database lock - we will map all these out at the trial start
Real-time dashboard, periodic data cuts/analysis, and final database lock. All follow quality metrics set forth at the trial start
Clinical Trial Management and Monitoring
Remotely monitor trial data, and resolve data issues in a timely manner
Train the sites on the study, and keep their training up to date
Troubleshoot site issues and collect data seamlessly
Keep an open line of communication with the sites and resolve problems before they happen
The founders are Sridhar Byrapppa and Vinodh Balaraman, both tech-savvy repeat entrepreneurs. Between us, we have 40+ years of pharma industry experience and expertise in business growth and execution. We have experienced the problems with drug development firsthand. Sridhar has operational experience at large pharma companies (Merck, Wyeth, Schering Plough, BMS and Stryker). He has a Ph.D. in Microbiology and has firsthand experience with the travails of drug development and executing large global clinical trials. Vinodh has worked on large life sciences consulting assignments and led multifold growth as a Senior Partner at ZS and SVP at Atos. He is an IIT Chennai graduate and has an MBA from Chicago Booth. It is our collective effort to bring cutting-edge technologies to drug development - speed up drug trials, reduce development failure rates, and get a greater number of drugs to the market.