The Covid-19 pandemic has shined 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 worldwide 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 (biointellisense.com) to offer the BioSticker, allowing for the collection of continuous patient data. The BioSticker collects over 14 vital signs including skin temperature monitoring and cough detection.
The ClinOne solution and its suite of products were created to improve clinical trial enrollment and remote patient compliance. The company’s sole mission is to profoundly improve connectively 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.