CliniOps Awarded Patent for an Innovative Offline/Online eSource, or Direct Data Collection (DDC) System, for Global Clinical Trials

Custom-Built Platform to Support Clinical Trials (CTs) Across Africa and Low & Middle Income Countries (LMIC)

U.S. Patent No. 11,967,402

CliniOps, Inc., an innovative technology and data science company for the life science industry, has once again demonstrated its capability to innovate and respond to unmet needs in CTs, particularly, the challenge of managing data collection in remote and disparate regions across Africa and LMIC countries. The U.S. Patent and Trademark Office (USPTO) awarded CliniOps the U.S. Patent No. 11,967,402 on April 23, 2024, titled “System and Method for Offline Data Collection and Synchronization for Managing a Clinical Trial.” Avik Kumar Pal, CEO, and Yerramalli Subramaniam, CTO, are listed as patent inventors. 

CliniOps' products were designed to help sites make a technology leap from paper sources to electronic sources, utilizing mobile devices with complete offline capability. This ensures that the trial is conducted digitally, and that no eligible participants to any CTs are excluded due to location and/or access issues. Participants are recruited and are engaged in CTs using easy-to-use smart devices for data collection, irrespective of whether electronic connectivity is available or not. As more participants join CTs from diverse location, there is increased assurance that the studies are more diverse and inclusive of underrepresented populations. This novel technology digitizes the clinical data management of large-scale, multi-center, multi-country CTs involving tens of thousands of participants who are based in remote or hard-to-reach sites, with minimal or no electronic connectivity.   

“Our patent is a validation of the uniqueness and significance of applying offline capability in collection and synchronization of clinical and non-clinical data in CTs conducted in remote sites. In parts of Africa, Asia and LATAM, CliniOps’ offline data collection solutions are deployed in CTs that investigate effectiveness of diagnoses and treatments for public health diseases such as tuberculosis, malaria, onchocerciasis, scabies, lymphatic filariasis, HIV/AIDS, including several vaccine, pediatric and maternity and child health studies," said Avik Pal, CEO.

“CliniOps’ offline/online data collection capability is part of our unified platform approach in data management of CTs. In clinical sites, smart tablets can be deployed to directly capture data: enrollment, medication intake, adverse events, among others. Site staff can go to areas with spotty or no connectivity and be able to enter data, which is synchronized later with backend database when connectivity is available,” said Yerramalli Subramaniam, CTO. “To ensure very clean data is collected to begin with, high-level quality-validation checks are performed instantly at the point of care, which significantly minimize downstream data-cleaning activities, allowing for near real-time data access for study monitors.”

About CliniOps:

CliniOps is a leading Technology and Data Science company for the Life Science Industry. The CliniOps innovative platform makes clinical research accessible, inclusive, faster, and efficient.

Source: CliniOps, Inc.

About CliniOps, Inc.

CliniOps, Inc. is a leading Technology and Data Science company for the Life Science Industry. CliniOps’s Unified platform approach enables home-visit, site-visit, tele-visit and lab-visit, leveraging AI, Mobile, Analytics, Cloud, Sensors and Connected Devices. CliniOps is currently supporting trials across 30+ countries. CliniOps is featured in the Gartner Hype Cycle for Life Sciences R&D five years in a row since 2018. and follow CliniOps on LinkedIn and Twitter.

CliniOps, Inc.
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