- 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
