pharmtrace klinische Entwicklung GmbH

Booth number 4617-05

www.pharmtrace.com

Flexible management of clinical trials with GCP-compliant image collection, quality control, data management of studies in nuclear medicine and radiology.

About us

pharmtrace provides expertise for clinical trial management when medical imaging is a clinical endpoint. Our team is globally experienced in managing nuclear medicine drug development trials from beginning to end.

pharmtrace’s services cover all aspects in the life cycle of a clinical trial: study design development, regulatory affairs, site selection & qualification, clinical and image database management, data transfer and statistical analysis.

Image management covers site qualification & training, image upload, technical and medical quality control, independent read planning, and reader training.

We provide the know-how to optimize the design and operational management of clinical trials to generate GCP-compliant image data to address developmental milestones and regulatory questions.

Our proprietary image platform ERICA is fully compliant with all applicable regulations​ (21CFR11, GCP, GAMP5, HIPAA)​ and works from any computer without extra software installation.

Address
pharmtrace klinische Entwicklung GmbH
Wolframstr. 93–94
12105 Berlin
Germany

Phone: +49 30 63222700
Internet: www.pharmtrace.com

Contact person

Bernard Ayton
Business Development
Phone: +44 131 447-3447
Representative
pharmtrace Inc.
One Liberty Place
19103 Philadelphia
U.S.A.

Products and Services

The Electronic Read and Independent Case Assessment system ERICA supports imaging related workflows in clinical trials. It serves as image repository and includes modules for technical and medical image quality control.

Sites can directly and conveniently upload images into the ERICA warehouse via a secure internet connection, no local software installation is needed. Images are automatically de-identified during upload. The ERICA image QC module supports the technical quality control of medical images as part of the preparation for independent image assessments. All image QC results are transparently stored and accessible to customized user profiles.

ERICA provides direct oversight and control of critical clinical imaging related processes. ERICA was developed and validated by pharmtrace in real-life clinical trials to correctly document clinical imaging trials with GCP-compliance. ERICA makes sure medical imaging in clinical trials delivers robust and meaningful clinical data.

News & Innovations

ERICA: professional solution for controlled image reads.

The ERICA platform be accessed from anywhere in the world via a secure internet connection and will be programmed according to your specific study and reporting needs.

  • ERICA image warehouse: Images are collected and systematically QCed to create a structured image warehouse. Email notification provides instantaneous updates. Images can be downloaded for local interpretation.

  • ERICA remote standard read: Built on the image warehouse, this option allows remote image interpretation with additional steps to verify its correctness, completeness, and consistency. Results from the read can be entered into the eCRF provided as part of the ERICA system, or into the clinical eCRF.

  • ERICA centralized read: Readers read all images in the pharmtrace office with full control of the reading environment. This option provides maximum control.

    Interested – please visit our Booth at the San Diego Bio 2022 meeting (German Pavilion) or email info@pharmtrace.com to arrange a meeting / demonstration.
pharmtrace – ERICA control the integrity of your clinical trial medical images.
ERICA, your flexible platform for the GCP-compliant collection, quality control, review, and management of radiological and nuclear medicine images from clinical trials with the flexibility of up-to-date image visualization and analysis tools.

Options for local installation and administration gives customers direct oversight and full control of all clinical imaging related processes including the ability to monitor key study performance and quality metrics. Validated in numerous clinical trials and complemented by independent expert support, ERICA comprehensively supports all trials from single site to worldwide, phase I to Phase IV.

Interested – please visit our Booth at the San Diego Bio 2022 meeting (German Pavilion) or email info@pharmtrace.com to arrange a meeting / demonstration.
Further reading
Independent Expertise – Imaging / Nuclear Medicine Endpoints in Clinical Trials
If you are seeking support for one of your clinical trials with an imaging endpoint, perhaps pharmtrace with its expertise in imaging, diagnostics and drug development is an option to consider.

We bring a full understanding and appreciation of imaging, nuclear medicine, and radiopharmaceuticals, as a safeguard to ensure the non-typical nuances of trials with imaging endpoints do not become problematic to the efficiency and integrity of their clinical trial. Whatever solution is appropriate for you, pharmtrace provides the control you need according to the status of your development project and your internal reporting and project management requirements.

Interested – please visit our Booth at the San Diego Bio 2022 meeting (German Pavilion) or email info@pharmtrace.com to arrange a meeting / demonstration.
Further reading

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