Medical imaging — neural visualisation

Independent CRO  ·  Berlin & Philadelphia  ·  Est. 2006

Clinical trials where
imaging defines
the outcome.

We specialise in studies where diagnostic imaging or radiopharmaceuticals define the outcome: contrast agent and diagnostic radiopharmaceutical development, RECIST response assessment in oncology, therapeutic radiopharmaceutical programmes, and medical device investigations. Imaging core lab, full CRO management, and consulting — across therapeutic areas and all development phases.

For twenty years, we have been the team sponsors call when imaging is not a secondary endpoint — but the reason the study exists.
Clinical trial management — data-driven oversight
01
CRO Services

Full trial management, imaging integrated from day one.

Unlike general-purpose CROs, imaging expertise is woven into every operational step — not treated as an add-on. From first-in-human exploratory studies to Phase 3 registration trials, we bring the same standard to every project.

  • Protocol development
  • Site selection & qualification
  • Regulatory affairs — FDA, EMA, national
  • Clinical monitoring (CRA services)
  • Data management & eCRF
  • Safety & pharmacovigilance
Full capabilities
Independent image read — radiologist at workstation
02
Imaging Core Lab

Independent management of imaging in your trial.

From imaging charter and site qualification through DICOM image collection, quality control, and blinded reads to the final results dataset — we manage every imaging step with the rigour that regulatory submissions demand. Response criteria covered include RECIST 1.1, iRECIST, PERCIST, and study-specific frameworks.

  • Imaging Charter development
  • Site qualification for imaging
  • DICOM collection, transfer & QC
  • Independent blinded reads — RECIST, iRECIST, PERCIST
  • Adjudication & expert panel assessments
  • Reader training & management
  • Statistical analysis & reporting
Full capabilities
Scientific consulting — collaborative planning
03
Consulting

Strategic advice for sponsors who take imaging seriously.

Two decades of direct experience in imaging-based trials across therapeutic areas and development phases. We help sponsors design programs that satisfy regulatory expectations and prepare for productive interactions with FDA and EMA.

  • Regulatory meeting preparation & support
  • Imaging endpoint strategy
  • Clinical development program design
  • Radioligand therapy program support
  • Due diligence
  • Expert panel organisation
Full capabilities
Oncology Radioligand Therapy Neurology Cardiology Medical Devices First-in-Human Phase 1 – 4 Marketing Authorisation
ERICA imaging platform — study management interface
Our Platform

ERICA — built for clinical imaging.

ERICA is our proprietary, fully validated imaging platform — purpose-built for the demands of clinical trials. It covers DICOM image storage, technical and medical quality control, and independent blinded reads in a single, regulatory-compliant environment.

Every project-specific configuration is separately validated. No general-purpose software adapted for clinical use — a system designed from the ground up for this work.

GAMP5 Category 5 — full custom application validation
FDA 21 CFR Part 11 — electronic records & signatures
ICH-GCP & ISO 14155 — pharmaceutical & device trials
Per-study configuration validation — no blanket approvals
20

Twenty years. Independent. Private.
Committed to the work.

Berlin · Philadelphia · Est. 2006

Where we work

Berlin and Philadelphia.

Germany

Berlin

Wolframstrasse 93–94
12105 Berlin
+49 30 63 222 700 info@pharmtrace.com

United States

Philadelphia, PA

One Liberty Place
1650 Market Street, Suite 3600
Philadelphia, PA 19103
info@pharmtrace.com

pharmtrace is a member of CONELIS, a Berlin-based network of independent experts in pharmaceutical drug development — enabling rapid access to non-clinical, toxicology, CMC, biostatistics, regulatory, and market access expertise as project needs require.conelis.org ↗