Radiation Therapy

Specialized Expertise in Radiation Clinical Research

Medpace has proven expertise in radiation oncology, radiation device, and radiopharmaceutical clinical trials. Our radiation group has a consistent track record of success as a full-service CRO that can ensure flexibility to adapt to the unique needs of each radiation clinical trial. Our in-house experts are board-certified radiation oncologists, radiologists, radiation physicists, and dosimetrists who are embedded within the research project team. Our MDs and PhDs are fully-involved throughout each study and provide leadership for Sponsors. Our physicians train the clinical operation project team and investigative sites on the nuances of each trial. Consistent oversight by medical monitors and physicists, ensure that our sponsor’s trials are executed to their specifications throughout the life cycle of the study.   

Our experience with global regulatory authorities, coupled with early planning and collaboration with Sponsors, accelerates the path to approval. Our therapeutically trained teams include radiation-focused clinical trial managers and program coordinators who provide knowledgeable training to sites and help mitigate challenges.

Our physicians and professional staff understand the complexities of radiation therapy and radiation oncology trials from the perspective of the Sponsor, the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. We bring these perspectives to each clinical trial that we conduct.

  • Broad 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
  • Embedded radiation oncology leadership for coordination and execution of complex radiation studies
  • Medical leadership that supports interdisciplinary relationships within and between Principle Investigators, KOLS, sites, vendors and Sponsors
  • Provide radiation therapy (RT) quality assurance services for radiation studies and RT plan review
  • Provide central reader services for radiation oncology and diagnostic radiology

  • Expert guidance on protocol, imaging acquisition, and analysis for dosimetry
  • Expertise in diagnostic, therapeutic, and theranostic 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 dosimetry
    • Dose calculations, internal dosimetry

  • 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
  • Centralized management for the co-ordination and execution of imaging study aspects
  • Support the development and growth of inter-disciplinary relationships within and between sites, vendors and Sponsors
  • Provide scientific and strategic guidance for protocol development
  • Standardized electrocardiogram (ECG) equipment to support Phase I-IV clinical trials around the world
  • Provide central reader services

  • Global, regional, and country-specific regulatory strategies to facilitate development of radiotherapeutics, radiodiagnostics, and radiation medical devices
  • Leverage regulatory intelligence and precedence to support phase- specific and long-term clinical development plan of Sponsor
  • 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 theranostics
  • Regulatory Chemistry, Manufacturing and Control support for phase-appropriate characterization of this special class of compounds to ensure alignment with regulatory expectations
  • Provide scientific and strategic guidance for developing documents for milestone regulatory submissions

  • Centralized management for the co-ordination and execution of all study aspects, including technical areas such as Chemistry, Manufacturing and Control
  • Support the development and growth of inter-disciplinary relationships within and between sites, vendors and Sponsors
  • 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
  • Informed, operationally focused risk mitigation strategies
  • Established contacts and oversight of vendors for manufacture and sourcing of specialized supporting products