Virtual research organisations (VRO) ObvioHealth and Sterling IRB have announced a collaboration to help accelerate the access to, and adoption of, decentralised clinical trials (DCT).
Under the partnership, Sterling IRB will become the preferred Institutional Review Board for ObvioHealth and provide its regulatory expertise.
This paves the way for obtaining regulatory approvals for ObvioHealth’s clinical trial designs.
ObvioHealth CEO Ivan Jarry said: “The flexibility of our DCT platform, combined with our full-service virtual site team, gives us the freedom to build studies that will best deliver on a sponsor’s endpoints.
“This often means we’re navigating uncharted regulatory terrain. We needed a partner willing to collaborate through regulatory challenges and support our next-generation trial designs.”
ObvioHealth minimises burden for patients and delivers stronger therapeutic evidence for sponsors by designing and running tech-enabled clinical trials.
The company’s protocols often include advanced data capture methods such as audio and image capture, telehealth, and wearables.
ObvioHealth and Sterling IRB’s collaboration is rooted in an understanding of the DCT model that will enable a seamless regulatory review process.
Sterling IRB vice-president of Client Services, Institutional Official Kathye Richards said: “Sterling IRB and ObvioHealth are like-minded, both sharing a common goal of building stronger DCTs.
“Flexibility and out-of-the-box thinking are becoming increasingly important for continued decentralised trial success. This partnership will enable earlier involvement to help interpret regulations, work through challenges, and collaborate for solutions, all essential for making DCTs less burdensome for all.”
ObvioHealth and Sterling IRB have already commenced partnership on a fully virtual CNS device study and a paediatric nutritional study.
Decentralised Clinical Trial coverage in Clinical Trials Arena is supported by Huma.
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