What we do
Services for trials where imaging matters.
Three integrated service areas for clinical trials in which imaging or radiopharmaceuticals play a defining role — whatever the therapeutic area, whatever the phase.
Three integrated service areas for clinical trials in which imaging or radiopharmaceuticals play a defining role — whatever the therapeutic area, whatever the phase.
Full-service clinical trial management by a team that understands imaging and radiopharmaceuticals as deeply as clinical operations.
We have managed clinical trials across oncology, neurology, cardiology, and other therapeutic areas — from first-in-human exploratory studies through Phase 3 registration trials and Phase 4 post-marketing commitments. In each, imaging expertise was built in from the protocol stage, not retrofitted.
Our experience includes studies that have supported marketing authorisation applications to FDA and EMA. We know what these submissions require and design our processes accordingly from the outset.
ERICA is not an adapted general system — it was built specifically for clinical imaging trials and is validated to GAMP5 Category 5.
Single-read, double-read, and adjudication designs with maintained blinding throughout — documented for regulatory submission.
CT, MRI, PET, SPECT, hybrid imaging — radiopharmaceuticals and conventional agents.
ICH-GCP, ISO 14155, FDA 21 CFR Part 11, EMA guidelines — applied to every project, not as a checklist but as a working standard.
End-to-end, independent management of imaging in your clinical trial — from first scan to final dataset.
pharmtrace's Imaging Core Lab provides comprehensive support for all imaging aspects of clinical trials and medical device investigations. Whether your study applies RECIST 1.1 or iRECIST for tumour response in oncology, PERCIST for PET-based assessment, quantitative MRI endpoints in neurology, SPECT imaging in cardiology, or quantitative imaging for a medical device investigation — we standardise, collect, quality-control, and independently review images with the rigour that regulatory submissions require.
Our proprietary ERICA platform, validated to GAMP5 Category 5, serves as the single environment for DICOM image storage, technical and medical QC, and blinded read sessions — with per-study configuration validation for every project.
Strategic advice from people who have spent twenty years at the intersection of clinical development, imaging science, and regulatory affairs.
We support sponsors at any stage — from early imaging strategy and endpoint selection through regulatory meeting preparation and marketing authorisation support. Our advice is grounded in operational experience, not theory.
Through the CONELIS network, we can assemble interdisciplinary expert teams for complex advisory needs — covering non-clinical science, toxicology, CMC, biostatistics, regulatory affairs, and market access — on demand, without the overhead of a large organisation.
