An industry leader in radiation therapies and imaging and the only CRO combining global reach, full-service and in-house dosimetry and medical physics.
An industry leader in radiation therapies and imaging and the only CRO combining global reach, full-service and in-house dosimetry and medical physics.
Integrated Operational, Medical, and Imaging Expertise Embedded in Radiation Therapy Trials
In the era of targeted therapies, radiation oncology, radiopharmaceuticals, and radiation devices have made incremental developmental advances due to clinical research. With the continuous increase in radiation applications, and as boundaries continue to be challenged with new technologies and isotopes increasing trial complexity, the need is greater than ever for specialist teams who can execute clinical trials with expertise and efficiency.
Mitigate risk and optimally achieve target endpoints in your radiation therapy clinical trial by partnering with a full-service clinical research organization with a consistent track record of excellence in radiation oncology research. Full integration of medical, imaging and physics experts with experienced operational teams ensures optimal study conduct and accelerates the path to approval by minimizing start-up barriers, anticipating challenges, and effectively managing the complexities often involved in radiation oncology clinical research. Long-established global presence and expertise provides complete geographic flexibility and an ideal long-term development partner from first in human to marketing authorization.
The Medpace Advantage in Radiation Therapy and Imaging Clinical Trials
Radiation therapies have advanced over the last decade, most notably in the fields of imaging and oncology. Our in-house, integrated team of radiation oncologists and imaging experts understand the biological, clinical, regulatory, operational, and imaging considerations that must be factored in when designing and executing radiation therapy trials and apply their specialized experience to effectively navigate trial complexities and execute the program seamlessly.
Embedded Medical, Imaging and Physics Expertise in Radiation Therapies
Our innovative, integrated approach combines the expertise of our radiation oncologists within our CRO, and of our imaging specialists and medical physicists within our Core Lab, to deliver world-class oversight and trial leadership. Leverage our in-house radiation therapy team’s understanding of the nuances in radiation oncology techniques, quantitative imaging analysis and dosimetry in your upcoming clinical trials.
Medical leadership that supports interdisciplinary relationships within and between Principal Investigators, KOLS, sites, vendors and Sponsors
Cross-disciplinary radiation oncology capabilities provide state-of-the-art services for either stand-alone or fully integrated projects with Medpace CRO
Board-certified radiation oncologists provide medical leadership to enhance and expedite radiopharmaceutical and radiation device development
Nuclear Medicine Imaging for Diagnostic and Therapeutic Endpoints and Dosimetry
Benefit from the imaging specialists and medical physicists at our fully-integrated Medpace Core Laboratory (MCL), which provides centralized management for the coordination and execution of imaging study aspects.
Broad imaging modalities provide state-of-the-art core lab services for either stand-alone or fully integrated projects with Medpace CRO
End-to-end suite of global imaging services to enhance and expedite centralized oncology assessments
Customized imaging acquisition protocols for the biodistribution and radiation dosimetry of beta and alpha-emitting radiopharmaceuticals
Biotech companies and nuclear medicine departments are focusing on dosimetric approaches that enhance therapeutic benefits to patients while adhering to regulatory authority requirements. Well-informed dosimetry input is essential for achieving success in radiopharmaceutical therapy clinical trials and is often integral to development pathways and regulatory requirements.
Medpace offers complete dosimetry analyses, fully integrated within ClinTrak® Core Lab for optimal efficiency in dosimetry workflow. Dosimetry services also include:
Expert guidance on protocol, imaging acquisition, and analysis for dosimetry
Expertise in diagnostic, therapeutic, and theragnostic radionuclides
Customized, live site training performed by Imaging Technologists supports high quality data and compliance with imaging specifications for dosimetry
Services provided by Medpace Core Lab (MCL) dosimetry include but are not limited to study planning, instrument and scanner calibrations, uptake assessments and radiation absorbed dose calculations
Study management for radiopharmaceutical trials is highly complex and cross-functional. Medpace industry leading radiopharmaceutical study teams employ robust established processes and best practices, combined with comprehensive training and ongoing education, to deliver quality execution of each radiopharmaceutical trial. Additional in-house support on technical and specialist topics is integrated as needed and our physicians, advanced clinical practitioners, Clinical Trial Managers and CRAs go the extra mile to support the investigative sites, ensuring each trial is performed safely and efficiently.
Full-service integration delivers higher quality results for managing the complexities and challenges of radiopharmaceutical studies:
Centralized management for the coordination and execution of all study aspects, including technical areas such as Chemistry, Manufacturing, and Control
Seamless integration of Medpace Core Laboratory (MCL), Medpace Reference Laboratory and Clinical Packaging and Supplies within the study team ensures efficient and harmonized processes throughout the study lifecycle
Fully customized study plans and procedures, adapted to the needs of each radiopharmaceutical product
Clinical Monitoring strategies optimized to meet the demands and restraints of radiopharmaceutical trials, including informed, operationally focused risk mitigation strategies
As the regulatory frameworks for radiopharmaceuticals vary globally, the applicable regulatory pathway for a given geography will be based on the type of product, the intended use, and associated risks. Our dedicated and knowledgeable global regulatory submissions team and global regulatory affairs teams provide comprehensive support throughout the development process.
Global, regional, and country-specific regulatory strategies to facilitate diagnostic, therapeutic and theranostic trials
Strategic regulatory assistance and support with timely interactions with Regulatory Authorities to gain alignment and to negotiate complex issues specific to radiation therapies
Regulatory Chemistry, Manufacturing and Control support for phase-appropriate characterization of this special class of compounds to ensure alignment with regulatory expectations
Knowledge and experience of regulatory pathways and requirements for different product types to ensure compliance and achieve efficient clinical trial start-up and initiation
The Medpace dedicated cross-functional Radiation Therapy Leadership Forum provides a structured framework to enhance and optimize the conduct of all Medpace radiopharmaceutical trials globally and supports continued education process and technological innovation.
All functional areas represented across wide variety of therapeutic areas, indications, phases and geographies
Review of current regulatory and clinical landscape relevant to radiation therapies and radiopharmaceuticals
Identify patient-centric strategies to better meet patient needs
Develop project management tools and training specific to nuclear medicine studies and clinical trial operations
Radiopharmaceutical certificate program covering multiple functional areas including Clinical Operations, Medical and Scientific Background, Regulatory, Monitoring, Biostatistics and more
Global Relationships & Resources
Our extensive Global Site Network, supplemented by our Flagship Site Programme, grants immediate access to highly experienced Nuclear Medicine sites and investigators worldwide. Long-standing relationships allow us to leverage existing connections and knowledge of site processes specifically for nuclear medicine studies to optimize start-up strategies, allowing our teams to proactively identify and mitigate potential issues and execute the shortest possible timeline to site activation. With SOPs and additional resources specifically designed to support less experienced sites, our network is constantly expanding to ensure your study recruits to target unphased by site saturation or competing studies.
These relationships paired with our strong connections with KOLs, regulators and specialized vendors ensure unmatched efficiency in strategic site identification, start-up, and recruitment. Leveraging these alongside our proprietary IntelliPACE feasibility strategy and dedicated in-house patient recruitment teams allow us to accelerate site selection and patient enrollment while optimizing retention. This seamless integration keeps your radiopharmaceutical and radiation therapies on time, on budget, and positioned for success.
“Always aligned with our Sponsor’s goals, we make sure that trials are poised to enroll quickly, treat patients safely, and eliminate unnecessary redundancies.”
