What Pharmtrace does

Pharmtrace is a Berlin-based, privately held contract research organization founded in 2006 that provides clinical trial services for studies in which diagnostic imaging or nuclear medicine procedures are the primary component. The firm operates across three integrated service lines—full-service CRO management, an imaging core lab, and strategic consulting—with revenue generated through project-based contracts with global pharmaceutical companies, biotech firms, and academic sponsors. All three services are anchored by ERICA, a proprietary, GAMP5 Category 5 validated imaging platform purpose-built for clinical trials; ERICA covers DICOM image storage, technical and medical quality control, and independent blinded reads compliant with FDA 21 CFR Part 11, ICH-GCP, and ISO 14155 standards, with every project configuration separately validated.

The company's core differentiator is vertical specialization: imaging expertise is integrated from protocol stage through regulatory submission rather than retrofitted by a separate vendor, providing sponsors with a single point of accountability. The team is led by a board-certified nuclear medicine physician with a Charité Berlin academic appointment and prior radiopharmaceutical development experience at Schering AG, supported by two physicians, five doctoral scientists, and experienced clinical operations and data management professionals. Therapeutic focus areas include oncology (RECIST, iRECIST, PERCIST), therapeutic radiopharmaceuticals and radioligand therapy, neurology, cardiology, and medical devices.

Pharmtrace operates from Berlin (headquarters) and Philadelphia (North American office established January 2022) and conducts trials across Europe, North America, Asia (Japan, China, Vietnam), and Australasia. Through its CONELIS partnership, the firm can assemble interdisciplinary teams covering non-clinical science, toxicology, CMC, biostatistics, and regulatory affairs without permanent organizational overhead. The firm is privately held with no external investors and has not raised disclosed funding rounds, allowing it to focus narrowly on its imaging-centric niche without shareholder-driven growth pressure.

Name

Pharmtrace

Legal name

pharmtrace klinische Entwicklung GmbH

Website

https://pharmtrace.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

Pharmtrace is a privately held Berlin-based CRO founded in 2006 that runs imaging-centric clinical trials for global pharma, biotech, and academic sponsors via its proprietary GAMP5-validated ERICA platform, with offices in Berlin and Philadelphia.

Ownership category

akta.pro rank

Product category

Clinical Research Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Clinical Trial Pharmacy & IMP Management at Site (HLAGACAK), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH)

Keywords

• Clinical trial services
• Medical imaging core lab
• Contract research organization
• Radiopharmaceutical development
• Clinical imaging platform

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. CRO Services: Full-service clinical trial management including protocol development, site selection, regulatory affairs, clinical monitoring, data management, and clinical study report preparation. Revenue generated through project-based contracts for trial management.
2. Imaging Core Lab Services: End-to-end imaging management including Imaging Charter development, site qualification, DICOM collection, quality control, independent blinded reads, and statistical analysis. Revenue generated through per-project imaging services.
3. Consulting Services: Strategic advisory services including FDA and EMA meeting preparation, regulatory strategy, clinical development program design, imaging endpoint strategy, and due diligence support.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Pharmtrace is a specialized contract research organization (CRO) and imaging core lab that manages clinical trials in which imaging or radiopharmaceuticals are central endpoints. It delivers full-service clinical trial management (protocol development, site qualification, monitoring, data management) alongside end-to-end imaging core lab services (DICOM collection, quality control, independent blinded reads, dosimetry), all underpinned by its proprietary GAMP5 Category 5 validated ERICA imaging platform. It also provides regulatory and scientific consulting to pharmaceutical sponsors across FDA, EMA, and other regulatory frameworks.

Product overview

Pharmtrace offers an integrated platform of three interconnected service areas built around its proprietary ERICA imaging platform. ERICA serves as the core validated technology for DICOM image management, quality control, and blinded reads, which underpins both the Imaging Core Lab and CRO Services. The Consulting service leverages the same expertise to provide strategic advisory. The company operates as a specialized CRO where imaging is not a secondary endpoint but the reason the study exists, with all services designed to work together from protocol stage through regulatory submission.

Differentiator

Problem solved

Functional benefit

Brands

• ERICA: Proprietary, GAMP5 Category 5 validated imaging platform — purpose-built for DICOM image storage, technical and medical QC, and blinded reads in clinical trials. Every project-specific configuration is separately validated.

Products and services

• ERICA Imaging Platform Proprietary, GAMP5 Category 5 validated clinical imaging platform purpose-built for clinical trials. Covers DICOM image storage, technical and medical quality control, and independent blinded reads in a single 21 CFR Part 11 / ICH-GCP / ISO 14155 compliant environment, with per-study configuration validation.
• CRO Services Full-service clinical trial management with imaging integrated from day one. Covers protocol development, site selection and qualification, regulatory affairs (FDA, EMA, national authorities), clinical monitoring (CRA services), data management and eCRF, safety and pharmacovigilance, and clinical study report preparation for pharmaceutical and biotech sponsors.
• Imaging Core Lab Services End-to-end, independent management of imaging in clinical trials. Includes Imaging Charter development, site qualification for imaging, DICOM collection, transfer and quality control, independent blinded reads (RECIST 1.1, iRECIST, PERCIST, study-specific criteria), dosimetry for diagnostic and therapeutic radiopharmaceuticals, adjudication and expert panel assessments, reader training and management, and statistical analysis and reporting.
• Consulting Services Strategic advisory for sponsors running imaging-based clinical programs, grounded in two decades of practitioner experience. Covers regulatory meeting preparation and support (FDA, EMA), imaging endpoint strategy, clinical development program design, radioligand therapy program support, due diligence, and expert panel organization.

Named customers3 records

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• CONELIScoreStrategic or Co-development PartnerPharmtrace is a member of CONELIS, a Berlin-based network of independent experts in pharmaceutical drug development. Through this network, clients can access expertise across non-clinical science, toxicology, CMC, biostatistics, regulatory affairs, and market access. Members can be engaged individually or assembled as interdisciplinary teams for specific project requirements without the overhead of a large organisation. The partnership enables Pharmtrace to offer comprehensive drug development support beyond its imaging core competency.

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Clario (formerly Bioclinica): Clario is a leading imaging core lab and eClinical technology provider for clinical trials, offering independent blinded reads, image management, and DICOM workflows. It is the most direct functional comparable to Pharmtrace's ERICA-based imaging core lab, although it operates at significantly greater scale and across broader therapeutic areas.
• Calyx (formerly ICON Medical Imaging): Calyx is an imaging core lab and eClinical imaging solutions provider serving pharmaceutical and biotech sponsors, originally part of ICON plc. Comparable to Pharmtrace in its specialization in independent blinded reads, DICOM management, and image quality control for clinical trials.
• WorldCare Clinical: WorldCare Clinical is an imaging core lab focused on independent imaging review, quantitative imaging, and DICOM workflow for clinical trials. Closely comparable to Pharmtrace in offering independent blinded reads and imaging endpoint assessment in oncology and other therapeutic areas.
• inviCRO: inviCRO provides imaging core lab services and quantitative imaging biomarkers for clinical research, including preclinical and clinical imaging. Comparable to Pharmtrace in its imaging CRO orientation, with broader translational/imaging biomarker capabilities but similar specialist positioning.
• Molecular Neuroimaging Inc. Molecular Neuroimaging is a specialized imaging core lab focused on PET and nuclear medicine imaging in clinical trials, including radiopharmaceutical studies. Directly comparable to Pharmtrace's nuclear medicine / radiopharmaceutical imaging capabilities and a similar specialist boutique scale.

Broad incumbents

• ICON plc: ICON is one of the largest global CROs with substantial imaging core lab capabilities (formerly ICON Medical Imaging, now Calyx). It competes with Pharmtrace at the top end of the imaging CRO market and historically has served many of the same oncology and radiopharmaceutical sponsors.
• IQVIA: IQVIA is the largest global CRO and life sciences services provider, offering integrated clinical operations and imaging/biomarker services. Competes with Pharmtrace primarily for large multi-region trials where imaging is a component, and sets the scale benchmark Pharmtrace is benchmarked against.
• LabCorp (Covance Clinical Development): LabCorp's Covance segment is a major global CRO and central laboratory services provider, competing with Pharmtrace on full-service trial management and central lab/imaging capabilities. Represents the broad incumbent that sponsors often choose over specialist imaging CROs for end-to-end programs.
• Parexel International: Parexel is a global full-service CRO with substantial oncology, radiopharmaceutical, and imaging trial experience. Competes with Pharmtrace for the same enterprise pharma sponsor clients and Phase II/III imaging-heavy programs, though at substantially greater scale.
• Medpace: Medpace is a mid-to-large global CRO with a strong focus on oncology, cardiology, and other specialty indications, and operates integrated imaging services. Comparable to Pharmtrace in therapeutic focus (oncology, specialty areas) but at materially greater scale and with broader CRO capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pharmtrace