NEW YORK, February 2, 2023: ObvioHealth and Sterling IRB today announce a partnership to help speed access and adoption of decentralized clinical trials. This partnership makes Sterling IRB the preferred Institutional Review Board for ObvioHealth. Sterling IRB will provide its regulatory expertise, paving the way for ObvioHealth’s innovative clinical trial designs to gain regulatory approvals.  

ObvioHealth is a virtual research organization (VRO) that designs and runs tech-enabled clinical trials to reduce patient burden and deliver stronger therapeutic evidence for sponsors. ObvioHealth’s protocols often include cutting-edge data capture methods such as image and audio capture, wearables, and telehealth.

The emergence of decentralized trial tools has required reviewers, auditors, and other governing bodies to expand their knowledge of this innovative model. It has also compelled regulatory agencies to revise the project review process. ObvioHealth, a pioneer in the DCT space, is acutely aware of potential areas of concern around data security and privacy, the shipment of clinical supplies, and patient monitoring, to name a few.

“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,” said Ivan Jarry, CEO of ObvioHealth. “We needed a partner willing to collaborate through regulatory challenges and support our next-generation trial designs.”

The collaboration between ObvioHealth and Sterling IRB is rooted in a deep understanding of the DCT model that will facilitate a seamless regulatory review process. With more than a century of combined experience, Sterling IRB’s experts began helping clients pivot to DCTs during the pandemic, navigating the imprecise regulatory guidance while maintaining patient welfare.

“Sterling IRB and ObvioHealth are like-minded, both sharing a common goal of building stronger DCTs,” said Sterling IRB Vice President of Client Services, Institutional Official Kathye Richards. “Flexibility and out-of-the-box thinking are becoming increasingly important for continued decentralized 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.”

The companies have already begun collaborating on two studies: a fully virtual CNS device study and a pediatric nutritional study.