Fidēs imaging targets early-phase drug development with new iCRO model
Fidēs, a newly launched imaging contract research organisation (iCRO), has announced its formal entry into the clinical research market with a focus on early-phase drug development. The company debuted at the 2026 SCOPE Summit in January, positioning itself as a science-first partner for biopharma sponsors working in scientifically demanding therapeutic areas.
Unlike conventional imaging CROs that treat image acquisition as a procedural service, Fidēs embeds imaging strategy directly into clinical decision-making, with the stated aim of helping sponsors determine what to measure, why it matters, and when imaging data signals a need to change course.
Core therapeutic focus areas
Fidēs has defined its initial clinical focus around digestive disease and motility disorders, gastrointestinal oncology, female pelvic conditions – most notably uterine cancer and diseases of the endometrium – and select solid tumours. The company’s scientific approach extends imaging beyond standard endpoints, applying quantitative and translational imaging principles to evaluate tumour microenvironment characteristics, organ function, and treatment impact on surrounding tissue function and texture.
The organisation also applies interrogation of standard-of-care imaging data to support more precise patient stratification, articularly in fibrotic conditions shaped by chronic underlying inflammatory activity, with the intention of informing early go/no-go decisions in drug development programmes.
The Aperis platform
Central to Fidēs’s technical offering is Aperis, its proprietary web-native imaging platform, which is 21 CFR Part 11 compliant and designed for multi-modality use. The platform provides sponsors with real-time access to imaging data throughout a study, rather than only at scheduled interim transfers, enabling closer collaboration between sponsors, investigative sites, and expert readers.
Key capabilities include embedded electronic case report forms (eCRFs) within the imaging environment – intended to reduce transcription errors and support data integrity – alongside advanced visualisation tools including semi-automated, multi-vector 3D modelling. The viewer supports simultaneous side-by-side review of multiple imaging modalities within a single interface.
Aperis is maintained by an in-house technology team and is designed to be continuously adapted to accommodate novel endpoints, functional measurements in moving organs, and the integration of third-party and sponsor AI algorithms as study requirements evolve.
Transparency as a design principle
Fidēs frames data transparency as both a cultural value and a practical feature of its model. Sponsors are given direct visibility into imaging data, annotations, and study progress throughout a programme. At study completion, all data, measurements, and analyses are designed to be transferable directly to the sponsor’s own environment.
Roughan Sheedy, CEO of Fidēs, described the company’s founding rationale: “Too often, early-stage imaging is conducted using restrictive, routine workflows. 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.”
On the company’s broader scientific role, Sheedy added: “Our role isn’t just to deliver images. It’s to help sponsors acquire and interpret the optimal data and extract enhanced insights, even when the answer is uncomfortable. That kind of honesty is how better science happens.”
Fidēs is headquartered in London, UK.
For more information, visit: https://fidesimaging.com
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