About

About pharmtrace klinische Entwicklung GmbH pharmtrace is an independent CRO providing strategies and solutions for clinical trials. pharmtrace offers flexible services and a global reach for studies with imaging endpoints, radiopharmaceuticals, and radiological interventional procedures. pharmtrace’s experienced team and international medical specialists network ensure that your investment in medical imaging, radiopharmaceuticals and radiological interventions delivers meaningful data. With our GCP compliant image management platform (ERICA) we support you to generate robust data to convince authorities and decision makers, and to achieve your development target. pharmtrace’s customers include biotech and academia, as well as internationally engaged pharmaceutical companies and device manufacturers. Full-service clinical trial management by a team that understands imaging and radiopharmaceuticals as deeply as clinical operations. pharmtrace is a private, independent contract research organisation for the pharmaceutical and medical device industry. We focus on clinical studies where diagnostic imaging and/or nuclear medicine approaches are a major component for efficacy or safety assessment — including RECIST-based oncology trials, therapeutic radiopharmaceutical programmes, and medical device investigations. Our clients are global pharmaceutical companies, biotech firms, and academic sponsors across North America, Europe, and Australasia. 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. 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. 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.