Fidēs has launched as a new imaging contract research organization (iCRO) purpose-built for early-phase clinical development, where imaging choices can decisively shape scientific direction, risk, and outcomes.

The company’s formal debut coincides with its presence at the 2026 SCOPE Summit, highlighting a clear focus on hands-on engagement with early-stage clinical innovators.

Fidēs enters the market to fill a widening gap in the imaging CRO landscape: the need for deeply embedded, science-led partners who help sponsors decide what to measure, why it matters, and when imaging data signals a need to change course. Rather than treating imaging as a transactional service, the company integrates imaging strategy directly into clinical decision-making.

Built at the intersection of scientific rigor and agile, software-inspired development, Fidēs continuously adapts imaging strategies to keep pace with evolving biology, trial designs, and endpoints. The company is deliberately focused on programs where imaging insight can meaningfully influence development decisions, particularly in complex and rapidly evolving therapeutic areas.

Fidēs brings core strengths across imaging applications and human biology, supporting work in digestive disease, GI oncology, and select solid tumors. The company is also advancing imaging innovation in the female pelvis, with particular emphasis on uterine cancer and diseases of the endometrium.

"Too often, early-stage imaging is conducted using restrictive, routine workflows," said Fidēs CEO Roughan Sheedy. "Fidēs was built to do the opposite: to embed imaging expertise directly into scientific decision-making, to challenge protocols that won’t deliver insight, and to help teams understand early whether their program is working, or not."

At the center of Fidēs’s model is Aperis, its proprietary, flexible, web-native imaging platform. Aperis provides sponsors with real-time access to imaging data throughout a study—rather than limiting visibility to interim transfers—enabling faster feedback, greater transparency, and closer collaboration among sponsors, sites, and expert readers.

The platform integrates electronic case report forms directly into the imaging environment to reduce transcription errors and strengthen data integrity. Advanced visualization tools, including semi-automated, multi-vector 3D models, allow multiple imaging modalities to be reviewed side by side within a single interface.

Supported by an in-house technology team, Aperis is continuously adapted to support novel endpoints, functional measurements in moving organs, and the integration of third-party algorithms as studies evolve.

Scientifically, Fidēs extends imaging beyond conventional endpoints, particularly in early oncology development. Leveraging deep expertise in complex gastrointestinal systems, the team applies quantitative and translational imaging approaches across solid tumors and other organ systems to assess tumor microenvironment characteristics, organ function, and treatment impact on surrounding tissue structure and texture.

The company also re-examines standard-of-care imaging data to enable more precise patient stratification, especially in fibrotic diseases shaped by years of chronic inflammation, generating richer insight to support early go/no-go decisions.

Transparency is both a cultural principle and an operational feature of Fidēs’s approach. Sponsors have direct visibility into imaging data, annotations, and study progress, positioning Fidēs as an extension of the sponsor’s research team rather than a black-box vendor. At study completion, all data, measurements, and analyses are directly transferable to the sponsor’s environment to support future research.

"Our role isn’t just to deliver images," Sheedy asserted. "It’s to help sponsors acquire and interpret the optimal data and extract enhanced insights, even when the answer is uncomfortable."

Sheedy added: "That kind of honesty is how better science happens."