CliniOps is a young health IT business that sees plenty of room for more efficient clinical trials by automating electronic document submission and reminders to participants to whittle down the huge price tag of drug development.
Although making data collection and submission faster by relying less on paper is one goal, CEO and founder Avik Pal sees WiFi dependence as a pitfall too. That’s not only because WiFi coverage may vary from one clinical trial site to another. WiFi can go down anywhere at any time and products designed to capture data online may lose that data if they lose their Internet connection.
Its CliniTrial Lite tool is designed to capture data offline using a tablet and synchs online. It does instant edit checks, and photo and video upload. It provides a way to access site data without the need for Internet connection. It also helps integrate data from medical devices and is HIPAA compliant.
“The biggest traction we are getting are people who like that it works completely offline,” Pal said in a phone interview with MedCity News. Its main customers are clinical trial sponsors and CROs.
Another component uses rich reporting capabilities to help principal investigator prepare reports with near real-time data to analyze trends, find discrepancies, monitor site compliance, and identify underperforming sites, according to its website.
Other tools focused on trial participants include using biometric verification through thumbprints to avoid duplication and false data entry. It also has electronic consent forms. An alert system triggers reminders for participants to take medication and notify them of upcoming appointments. Participants can view their own data by logging onto an interface set up for them and approve their records.
One part of CliniOps platform that is likely to generate a bit of controversy is the ability of participants to self-report data remotely instead of going to a site location for a scheduled visit. This is a potential Achilles’ heel because it can be challenging to verify whether each participant has followed protocol for self-reporting.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Patal has worked for a couple of startups that were acquired, including India-based Hexaware acquired quality management consultancy FocusFrame in a $34.3 million deal in 2006. CTO and co-founder Yerramalli Subramaniam worked at Applied Biosystems, which was acquired by Life Technologies/Thermo Fisher in 2008.
Among its advisors are Hugh Lavaux, who has worked for United BioSource Corp, Medidata Solutions and Quintiles. Dr. Patricia Salber is the founder and CEO of Health Tech Hatch, a group that supports healthcare innovation and entrepreneurs.
