Modern nuclear medicine is a high-tech discipline that requires advanced facilities, infrastructure, qualified staff, and know-how. The reliable supply of radionuclides, along with complex legislation, safety procedures, and manufacturing and clinical practice standards, poses a challenge for researchers. This is why a good imaging core lab in nuclear medicine is worth its weight in gold when conducting a clinical trial, especially for small- or mid-sized sponsors. Learn about our Imaging Core Lab and its potential for accelerating your research.
The scope of nuclear medicine clinical trials is broad. Such a trial might, for instance, evaluate a new theranostic radiopharmaceutical, repurpose an existing one for a different use, test new equipment, or compare different image analysis methods, among others. Thenuclearmedicine techniques are used in oncology, cardiology, neurology, and many other fields of medicine.
Regardless of the aim and subject of the trial, due to the special nature of radioactive substances, all nuclear medicine procedures must be meticulously planned, standardized, coordinated, supervised, documented, and analyzed. The research team must secure advanced equipment and facilities, highly qualified personnel, follow strict safety regulations and legal requirements, and meet the required quality standards for acquiring, storing, processing, and analyzing data. It requires quite a different set of skills than academics and scientists usually have. However, organizing clinical trials in nuclear medicine belongs to the most challenging undertakings, even for experienced researchers. That’s why contracting a CRO with an established imaging core lab is a real game-changer for sponsors.
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Axcellant’s Imaging Core Lab is a standardized, repeatable imaging solution delivered as a single, accountable CRO service. All critical capabilities—study design support, imaging operations, centralized data workflows, medical oversight, and quality management—are managed by Axcellant, ensuring uniform execution and clean decision pathways.
Thanks to our resources, we can plan and conduct multi-center trials across Europe and the USA. We are primarily focused on small and medium-sized clinical trial sponsors who expect agility, expertise, efficiency, speed, and a real patient impact.
To have a significant impact, a clinical trial’s results must be reproducible and consistent with the state-of-the-art criteria. This requires careful planning and standardization of every step, from protocol development through data analysis to publication.
Our Imaging Core Lab provides support in designing the study protocols and performs comprehensive standardization and validation of the protocols across all engaged trial sites, regardless of their localization. We account for local and international regulations and good-practice guidelines, technical requirements, and any non-standard, specific requirements that may arise. Thanks to our resources, you can find a partner to collaborate worldwide and be confident that the procedures are not only consistent within the trial but also compliant with all American[1], European[2],[3], and international regulations/standards?.
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For multi-site research, the site qualification and equipment standardization are crucial. We develop unified imaging charters[4] and imaging acquisition guidelines for the researchers, provide personnel training, and perform unified, phantom-based scanner calibrations[5] at every involved imaging lab before the trial and throughout it, as part of the routine maintenance. This approach ensures that the entire study proceeds smoothly and efficiently and that the acquired data are reliable.
Call us to learn why centralized imaging charters and phantom-based scanner calibrations are essential!
Once the protocols have been developed and the equipment is ready, it is time to focus on patient enrollment and the day-to-day procedures. Radioactive substances must be handled with utmost care on every level. The timeliness of the supply chain is as important as radiation safety, waste disposal, and incident monitoring.
Our Imaging Core Lab provides proper dosimetry measures, from coordinating phase 0/1 dose-adjusting clinical trials to ongoing dosimetry surveillance, ensuring the patient and staff safety throughout the study. Thanks to our centralized software system and a team of data-processing specialists, the imaging workflow is continuously monitored and reported to the client.
Not sure if your trial goes as planned? Contact us to regain control over your research! Worldwide: IAEA
Image quality assurance (QA) and ongoing quality control (QC) are essential for the reliability of study conclusions. Quality assurance begins with equipment calibrations and checks, as well as continuous monitoring services [6]. However, it continues throughout the entire image acquisition pipeline, including data storage, sharing, analysis, and publishing [7].
One of the most important aspects is the proper handling of the patients’ data. The images contain protected health information (PHI), which is necessary for the diagnostic and therapeutic process of individuals, but must be redacted before the data is shared, analyzed, and published. It is important for several reasons: first, to protect any personal data, and second, to avoid accidentally or prematurely unblinding the study. We provide tools for image PHI redaction and full compliance with applicable data protection legislation: GDPR[8] in Europe and HIPAA[9] in the USA.
Our Imaging Core Lab has the specialized software for detailed data analysis, including the extraction and processing of selected quantitative information from the scans. We also provide the electronic Case Report Form (eCRF) software adapted for clinical trials. Both systems enable our clients to ensure the quality, integrity, and security of all patients’ data.
Struggling to keep your data uncompromised? Learn why you can trust our expertise in data management!
Axcellant’s experts in the Imaging Core Lab are well-versed in the regulations in nuclear medicine, as published by EANM[10], IAEA[11], and other institutions. Thus, we can quickly identify potential problems and propose solutions . The supervision is comprehensive, encompassing all steps: from site qualification and protocol development to drug handling and data protection.
Learn how we helped our client avoid a tremendous waste of time and resources.
One of our clients wanted to evaluate a nuclear medicine approach in two cardiology procedures. The researchers planned to enroll 400 patients in two separate trial sites. However, one procedure was done and assessed differently in those facilities, making the results difficult (if not impossible) to compare. The client risked wasting time and resources by conducting advanced procedures only to obtain incompatible data sets.
Thanks to the centralized approach of our Imaging Core Lab, we identified this problem in advance and offered a solution. During the preliminary phase, we visited and assessed both trial sites. Then, we carried out necessary scanner calibration and developed uniform imaging protocols. During meetings with both medical teams, we provided them with the relevant instructions and training. Therefore, both clinical centers adopted a consistent way of performing the procedures. The acquired datasets were fully congruent, and the results were actually useful to patients.
The present and the future of nuclear imaging rely on very advanced, high-tech solutions. It is both a challenge and a great potential. The challenge lies mainly in the costs of specialized facilities and technical infrastructure. The prospects, however, are countless, including the integration of diagnostic techniques with therapeutic approaches, and digitalized, automated data analysis.
Axcellant’s Imaging Core Lab enables us to coordinate the nuclear medicine procedure end-to-end, at the highest level. We foster a close collaboration with world-class experts from the USA and Europe and have access to leading clinical settings and data management software. Therefore, our service as a CRO is closely intertwined with our core lab activity. Thanks to this, we can coordinate your research comprehensively and help you save time and money and avoid any organizational problems that may arise during third-party engagements.
Afraid of hiring too many professionals to coordinate your research? Axcellant will do it from A to Z!
[1] FDA and U.S. Department of Health and Human Services – Clinical Trial Imaging Endpoint Process Standards, Guidance for Industry, April 2018,https://www.fda.gov/media/81172/download (Accessed 10 Dec 2025).
[2] Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, https://eur-lex.europa.eu/eli/reg/2014/536/2022-12-05 (Accessed 10 Dec 2025).
[3] EMA guidelines: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-radiopharmaceuticals-diagnostic-agents#general-guidelines-79512 (Accessed 10 Dec 2025).
[4] Won SE, Kim S, Suh CH, Park HJ, Kim KW. Uncover This Tech Term: Independent Central Image Reading. Korean J Radiol. 2023;24(11):1164-1166. doi:10.3348/kjr.2023.0752
[5] The National Institute of Standards and Technology (NIST) service: https://www.nist.gov/health/what-are-imaging-phantoms, https://www.nist.gov/programs-projects/medical-calibrated-phantoms-monitoring-pet-and-spect-scanner-performance-clinical (Accessed 10 Dec 2025).
[6]EANM 2017, Quality Control of Nuclear Medicine Instrumentation and Protocol Standardisation: https://eanm.org/wp-content/uploads/2024/06/EANM_2017_TEchGuide_QualityControl-1.pdf (Accessed 10 Dec 2025).
[7] Clinical Trial and Imaging Subgroup report, https://www.ema.europa.eu/en/documents/report/clinical-trial-and-imaging-subgroup-report_en.pdf (Accessed 10 Dec 2025).
[8]https://gdpr-info.eu (Accessed 10 Dec 2025).
[9]https://www.hhs.gov/hipaa/index.html (Accessed 10 Dec 2025).
[10]https://eanm.org/publications/other-publications/technologists-guide/ (Accessed 10 Dec 2025).
[11]https://www.iaea.org/publications/14917/basics-of-quality-management-for-nuclear-medicine-practices, https://www.iaea.org/publications/10829/good-practice-for-introducing-radiopharmaceuticals-for-clinical-use (Accessed 10 Dec 2025).
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