Est. 2006
Twenty years focused on a single question.
How do you run a clinical trial where imaging defines the outcome? We have been answering that question in practice — not in theory — since 2006.
How do you run a clinical trial where imaging defines the outcome? We have been answering that question in practice — not in theory — since 2006.
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.
We organise clinical studies, conduct independent image reviews, and provide consultancy on imaging, radiopharmaceuticals, and radioactive devices in clinical development. Our clients are global pharmaceutical companies, biotech firms, and academic sponsors across North America, Europe, and Australasia.
Private ownership means no shareholder pressure to grow beyond our area of expertise. We remain what we have always been: a specialised team that does this work properly.
We work only on trials where imaging or radiopharmaceuticals are central. This is not a strategic positioning — it is how we were built, and why our expertise goes deeper than a generalist organisation can offer in this domain.
Privately held, with no conflicts of interest. Our scientific assessments reflect the data. Our operational decisions reflect the study requirements. Nothing else influences either.
We work as partners, not vendors. That means transparency about problems, early, and a shared commitment to making the study work — not just delivering a contracted scope.
Quality is not a function — it is the way we work. Our SOP system, validated platform, and continuous audit programme exist because we hold ourselves to the standard regulatory submissions require.
2006
pharmtrace is established with a focused brief: clinical trials where imaging or nuclear medicine procedures are a primary component.
2011
The first version of the ERICA image management system enters clinical use — a validated, purpose-built DICOM repository and QC platform for clinical trials.
2013
ERICA's blinded read module is deployed: a validated, 21 CFR Part 11-compliant environment for independent image reads. Single-read, double-read, and adjudication designs supported from the outset.
2019
A comprehensive restructuring of the SOP system is completed, alongside investment in remote infrastructure that would prove essential in the years that followed.
2022
pharmtrace incorporates in the United States in January 2022, opening its Philadelphia office and establishing a North American presence with a formal CEO/COO governance structure for the expanded group.
2023
A comprehensive technology upgrade brings ERICA to a modern, fully cloud-capable architecture — extending its scope to support remote expert assessments, distributed read panels, and a broader range of study designs beyond the platform's original configuration.
2026
pharmtrace enters its twentieth year. Independent. Private. Still focused on the same question we started with.
More than forty Standard Operating Procedures govern every regulated activity — from study preparation and monitoring through image handling, data management, safety, and closeout. Reviewed and updated on a defined schedule.
Proprietary. GAMP5 Category 5 validated. Purpose-built for DICOM image storage, technical and medical QC, and blinded reads. Every project configuration is separately validated — no blanket approvals.
Continuous internal and external qualification audits since 2006. Covering project processes, data management, image management, IT systems, and TMF compliance — with formal CAPA follow-up for every finding.
SOP training, GCP training, and task-specific competency verification before independent work on regulated activities. Documented through a dedicated training management system.
Comprehensive policies covering data integrity, GDPR compliance, and IT security. Electronic systems validated per GAMP5. All clinical data handling meets FDA 21 CFR Part 11 and EMA electronic data requirements.
Formal risk management at both project and company level. Risk-based quality management ensures that issues are identified early, triaged systematically, and addressed before they affect study integrity.
pharmtrace is a member of CONELIS — a Berlin-based network of highly qualified and independent experts in pharmaceutical drug development. Members can be engaged individually or assembled as interdisciplinary teams for specific project requirements.
Through CONELIS, clients access independent expertise across all aspects of drug development — non-clinical science, toxicology, CMC, biostatistics, regulatory affairs, and market access — on demand, without the overhead of a large organisation and without the conflicts of interest that come with integrated service providers.
conelis.orgNon-clinical development, pharmacology, and toxicology expertise for radiopharmaceutical and drug development programmes.
Chemistry, manufacturing and controls support across development phases, including radiopharmaceutical manufacturing.
Statistical analysis plan development, ADaM programming, and reporting across therapeutic areas and development phases.
FDA, EMA, and national authority interactions; market access strategy and health technology assessment support.