ClinOne’s Remote Clinical Trial Patient Management Technology Allows Pharmaceutical Companies to Continue Clinical Research Efforts Amidst the COVID-19 Pandemic in Accordance with FDA Guidelines
The COVID-19 pandemic has shown a bright light on the need to manage patients remotely wherever possible. This need is especially acute in clinical trials as identified by the FDA. Trial sponsors, physicians, and regulators are now embracing the use of technology to support patients and sites involved in clinical trials in ways needed to preserve the viability of the global clinical trial system.
“The FDA’s newly published guidance on conducting clinical trials during the COVID-19 pandemic advocates for remote patient management and virtual study visits. Clinical trials operate in a highly regulated environment and require highly specialized software to be compliant,” according to Rob Bohacs, CEO of ClinOne. ClinOne supports complete patient management, including purpose-built, encrypted virtual and video chat visits between the investigator, coordinator, and home healthcare provider for remote access and compliance management.
ClinOne solution also incorporates remote dosing management for patients, with complete communication between patients and providers to keep patients and treating physicians informed. The company recently announced its integration with wearable technology through the partnership with BioIntelliSense to offer the BioStickerTM, allowing for the collection of continuous patient data. The BioStickerTM collects over 14 vital signs, including skin temperature monitoring and cough detection.
The ClinOne solution and its suite of products aim to improve clinical trial enrollment and remote patient compliance. The company’s sole mission is to strengthen connectively profoundly and management of participating researchers, patients, and caregivers on-site and remotely. ClinOne’s systems are HIPAA, FDA CRF 21 Part 11, and GDPR compliant and validated and have been used by more than 30 sponsors, 90,000 investigators since 2016.