Fidēs unites deep medical expertise with a flexible suite of tools to streamline imaging processes, helping sponsors answer hard questions earlier in drug development
Key Takeaways:
Fidēs is a science-first imaging CRO (iCRO) dedicated to emerging & complex disease indications involving conventional and advanced medical imaging
Aperis, Fidēs’s in-house 21CFRp11 compliant multi-modality imaging platform enables seamless integration of clinical data with advanced central reading tools reducing central reading time and enhancing quality, whilst also facilitating integration with in-house and sponsor AI tools
Fidēs’s initial clinical focus areas include digestive disease and motility disorders, GI cancer, and female pelvis where their ability to integrate video and imaging data allows for comprehensive imaging trials
Fidēs today announced its launch as a new imaging contract research organization (iCRO) designed specifically for early-phase clinical development, where imaging decisions have the greatest impact on scientific direction, risk, and outcomes.The timing of Fidēs' formal launch with its presence at the 2026 SCOPE Summit underscores the company’s focus on industry engagement for early-phase clinical innovation.
Fidēs was created to address a growing gap in the imaging CRO landscape: the need for deeply engaged, science-led partners who help sponsors determine what to measure, why it matters, and when imaging data signals a need to change course. Rather than treating imaging as a procedural service, Fidēs embeds imaging strategy directly into clinical decision-making.
Fidēs combines deep scientific rigor with an agile, software-inspired development mindset continuously adapting imaging strategies to keep pace with evolving biology, study designs, and endpoints.
The company is purposefully focused on clinical programs where imaging insight meaningfully informs development decisions, particularly in scientifically rich and evolving therapeutic areas. Fidēs has core strengths across imaging applications and human biology, which underpin its work in digestive disease, GI oncology, and select solid tumors, as well as its groundbreaking work in the female pelvis, most notably in 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.”
Central to Fidēs’s approach is its proprietary, flexible, web-native imaging platform, Aperis. The platform provides sponsors with real-time access to imaging data throughout a study (rather than only at interim transfers) enabling greater transparency, faster feedback loops, and closer collaboration between sponsors, sites, and expert readers.
Key platform capabilities include embedded electronic case report forms (eCRFs) within the imaging environment, reducing transcription errors and supporting data integrity. Aperis also offers advanced in-built visualisation tools, including semi-automated, multi-vector 3D models. The viewer enables multiple imaging modalities to be reviewed side by side within a single window. Supported by an in-house technology team, the platform is continuously adapted to enable novel endpoints, functional measurements in moving organs, and the integration of third-party algorithms as studies evolve.
Scientifically, Fidēs differentiates itself by extending imaging beyond standard endpoints, particularly in early oncology development. Drawing on deep expertise in complex gastrointestinal systems, the team applies quantitative and translational imaging principles across solid tumors and other organ systems to evaluate tumor microenvironment characteristics, organ function, and treatment impact, on surrounding tissue function and texture.
Fidēs also interrogates standard-of-care imaging data to efficiently enable more precise patient stratification, especially in fibrotic conditions shaped by years of underlying inflammatory activity, providing richer insight to inform early go/no-go decisions.
Transparency is both a cultural value and a functional feature of Fidēs’s model. By giving sponsors direct visibility into imaging data, annotations, and study progress, Fidēs positions itself as an extension of the sponsor’s research team rather than a black-box vendor. At the end of your study, the data, measurements and analysis will be directly transferable to your environment to support future investigations.
“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.”
About Fidēs
Fidēs is a science-led imaging contract research organization partnering with biopharma sponsors on scientifically complex clinical programs. Built on deep expertise in gastrointestinal imaging and motility, Fidēs partners with biopharma sponsors to design adaptive imaging strategies, develop novel endpoints, and deliver transparent, data-driven insight where it matters most: early on.