Integrated Medical and Imaging Expertise Embedded in Radiation Therapy Trials
In the era of targeted therapies, radiopharmaceuticals, radiation oncology, and radiation devices have made incremental developmental advances due to clinical research. With the continuous increase in radiation applications, yet a scarcity of radiation therapy CRO clinical development expertise across the industry, there is a significant opportunity for radiation expansion in the clinical development landscape.
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 success in radiation oncology research. Our integrated team of medical and imaging experts accelerates the path to approval by minimizing start-up barriers, anticipating challenges, and effectively managing the complexities often involved in radiation oncology clinical research.
The Medpace Advantage in Radiopharmaceutical & Radiation Therapy Clinical Trials
Radiopharmaceutical drug development has advanced over the last decade, most notably in the field 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 radiopharmaceutical trials and apply their specialized experience in radiation therapies to effectively navigate trial complexities and execute the program seamlessly.
Radiation Therapy CRO Capabilities
Our innovative, integrated approach combines the clinical expertise of our radiation oncologists within our CRO, and the imaging capabilities of our radiation dosimetrists and physicists within our Imaging 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, dosimetry, and quantitative imaging analysis in your upcoming RT clinical trials.
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
Medical leadership that supports interdisciplinary relationships within and between Principal Investigators, KOLS, sites, vendors and Sponsors
Imaging Core Lab
Benefit from the radiation physicists and dosimetrists at our fully-integrated Imaging Core Laboratory, which provide 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
Provide an end-to-end suite of global imaging services to enhance and expedite biopharmaceutical and medical device development
Standardized electrocardiogram (ECG) equipment to support Phase I-IV clinical trials around the world
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.
Expert guidance on protocol, imaging acquisition, and analysis for dosimetry
Expertise in diagnostic, therapeutic, and theragnostic radionuclides
Services provided by Medpace Imaging Core Lab (MICL) dosimetry include but are not limited to study planning, nuclear medicine (NM), internal dose assessment, in vivo counter calibration and monitoring of radionuclides, dose calculations, external or internal dosimetry
As the US and EU regulatory frameworks for radiopharmaceuticals vary, 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 development of radiotherapeutics, radio-labelled, diagnostic, and radiation medical devices
Strategic nonclinical program guidance in the areas of toxicology, pharmacology, biodistribution, dosimetry that ensures regulatory success and provides maximal flexibility in the clinical development plan
Assistance with timely interactions with Regulatory Authorities to gain alignment and to negotiate complex issues related to radiotherapeutics, diagnostics, devices, and theragnostics
Regulatory Chemistry, Manufacturing and Control support for phase-appropriate characterization of this special class of compounds to ensure alignment with regulatory expectations
Clinical Operations
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/or 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.
The Medpace dedicated cross-functional Radiopharmaceutical 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
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 Imaging Core Laboratory, 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 radiopharmaceutical products and radiation devices
Clinical Monitoring strategies optimized to meet the demands and restraints of radiopharmaceutical product and device trials, including informed, operationally focused risk mitigation strategies
Radiation Oncology Clinical Trial Experts
Our in-house radiopharma leadership forum includes board-certified radiation oncologists, radiologists, radiation physicists, dosimetrists, radiation pharmacokineticists, and operational experts who are accustomed to managing complexities often encountered in radiation trials. Our experts provide leadership and offer consulting to small to mid-sized biotech and big pharma alike.
Global Relationships & Resources
Our strong relationships with investigators, key sites, regulators, institutions, specialized laboratories, and KOLs in Radiation Therapy help facilitate strategic site identification, start-up , and recruitment efforts. These relationships, combined with our proprietary IntelliPACE® feasibility strategy and dedicated in-house patient recruitment teams translate into expedited site selection and patient recruitment as well as increased patient retention to help keep trials on time and on budget.
“Always aligned with our Sponsor’s goals, we make sure that trials are poised to enroll quickly, treat patients safely, and eliminate unnecessary redundancies.”
Jess Guarnaschelli, MD Senior Medical Director, Medical Department, Radiation Oncology
