Januayr 10, 2022
There’s more than one way to architect a decentralized clinical trial (DCT). While this flexible model has many benefits, it can be overwhelming to bring together all the right elements to operationalize a trial that’s predominantly digital. Every trial is unique, so it is not realistic to templatize (impose a standard implementation template on) a DCT. But four common, fundamental components combine to facilitate a seamless, patient-centric DCT.
“It’s like a trial in a box, but each box is a little bit different,” said Steve Rosenberg, CEO of a cloud-based platform company that powers decentralized clinical trials. Even with a DCT’s inherent optionality, foundational components can ease implementation and improve execution.
BOSTON – January 5, 2022— Curavit Clinical Research announced today that it has taken all necessary steps to prove its good faith effort to achieve compliance with the Health Insurance Portability and Accountability Act (HIPAA). Through the use of Compliancy Group’s proprietary HIPAA solution, The Guard™, Curavit can track its compliance program and has earned its Seal of Compliance™.
The Seal of Compliance is issued to organizations that have implemented an effective HIPAA compliance program using The Guard. HIPAA is made up of a set of regulatory standards governing the security, privacy, and integrity of sensitive healthcare data called protected health information (PHI). PHI is any individually identifiable healthcare-related information. If vendors who service healthcare clients come into contact with PHI in any way, those vendors must be HIPAA compliant.
Curavit has completed Compliancy Group’s Implementation Program, adhering to the necessary regulatory standards outlined in the HIPAA Privacy Rule, Security Rule, Breach Notification Rule, Omnibus Rule, and HITECH. Compliancy Group has verified Curavit’s good faith effort to achieve HIPAA compliance through The Guard.
“HIPAA compliance is imperative for clinical research, increasingly so as the clinical trial model becomes more decentralized,” said Joel Morse, co-founder and CEO of Curavit. “As a virtual contract research organization that designs clinical trials from digital first principles, we take patient privacy very seriously, and have built our always–audit-ready platform on validated technologies that support our HIPPA compliant processes.”
According to a statement by Compliancy Group, “Clients and patients are becoming more aware of HIPAA compliance requirements and how the regulation protects their personal information. Forward-thinking providers like Curavit choose the Seal of Compliance to differentiate their services.”
Curavit Clinical Research is a virtual contract research organization (VCRO) that designs and executes Decentralized Clinical Trials (DCTs) from digital first principles. Founded by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, minimizing the need for physical infrastructure and travel while increasing data quality and reducing patient burden. Curavit brings together the world’s leading researchers, enrolls previously underrepresented and underserved patient populations, and applies machine learning to health and social engagement information to recruit participants. For more information, visit www.curavitclinicalresearch.com.
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