Faster Trials.

Faster drug to market.

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.

• 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
  

• 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
  

• 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
  

• 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
  

• 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
  

• 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
  

Partners

About us

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.

Cost-effective trial execution

Deep study insights

Faster drug to market

vinodh@trial8.com

sridhar@trial8.com

(201) 682-4647

Trial8 Inc

Belle Mead NJ