Molecular Imaging
Whether your prospective compound or novel radiotracer is in the early or late stage of trial development, RadPharm’s Molecular Imaging services can be leveraged to successfully gather, analyze and deliver crucial functional imaging data.
For early phase trials, we work with you to provide high-quality imaging efficacy data that empowers you to expedite critical go/no go decisions. Your team will be able to identify ineffective compounds earlier, saving valuable time and resources while allowing only your most promising compounds to advance in your drug development portfolio.
For late phase trials we provide functional imaging data which can be used as an exploratory endpoint or be integrated with the anatomic imaging data. This can be utilized for internal decision making and/or prepared
for agency submission.
At RadPharm, we understand that functional imaging data acquisition and analysis requires attention to
detail to ensure robust, accurate data sets. To that end, our certified imaging technologists and medical physicists work with qualified imaging facilities prior to and throughout the duration of the study.
Innovation
 Utilizing advanced, validated image analysis technology, RadPharm’s in-house board-certified radiologists and nuclear medicine physicians evaluate imaging data, both qualitatively and quantitatively. Image analysis is performed from traditional modalities including Computed Tomography (CT) and Magnetic Resonance Imaging (MRI), as well as Nuclear Medicine – Gamma camera imaging and Positron Emission Tomography (PET), and hybrid imaging such as Single Photon Emission Computed Tomography/CT (SPECT/CT) and PET/CT.
Our Experience
- 15 years accelerating drug and medical device development
- Over 27 Phase I and 15 Phase II studies in FDG-PET to date
- On-staff, full time board-certified physicians, scientists and technologists with decades of combined expertise
- Proven operational processes
- Broad therapeutic range including oncology, cardiovascular, musculoskeletal, CNS, diagnostic
contrast imaging agents and medical devices
Oncology Expertise
 RadPharm’s experience in the management of medical imaging for oncology clinical trials is unrivalled and includes medical expertise in all major oncologic tumor types. Our comprehensive molecular imaging service has a proven track record of an accelerated drug development process in both domestic and global oncology trials.
Molecular Imaging Service: FDG-PET
In addition to RadPharm’s world-class image management process, our Molecular Imaging service
provides value-added project management methodology and expert service tailored to your study needs
and specifications, including:
Imaging Facility Qualification
 Imaging facility evaluation
- Data format testing
- Phantom qualitative and quantitative assessments
- Imaging system stability and consistency analysis
- Physicist and Technologist support
Image Quality Assessment
- Pass/fail threshold criteria specific to your study
- Escalation, communication and correction plans
Image Analysis
- Flexible Assessment Paradigms
- Stand-alone FDG-PET analysis
- CT defined with correlative FDG-PET analysis
- Lesion Evaluation Assessment
- Anatomolecular Correlation
- Expertise in integrating physiologic and anatomic interpretation
- Response Assessment Criteria
- IHP 2007 – Lymphoma
- EORTC – Solid Tumor
Sponsor Benefits
- Accelerated timelines
- Cost & time efficiencies for expedited go/no-go internal decision making
- 'Fast-Track' regulatory submissions based upon credible trial data and processes
- Quality customer service – on-staff physicians, medical physicists, technologists and project
teams ready to answer your queries and exceed expectations
- Comprehensive service – complete end-to-end medical imaging solutions
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