BBMCT has proven expertise in radiation oncology, radiation device, and radiopharmaceutical clinical trials. 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. The ability to harness each person’s unique immune system in a meaningful to dampen the deadly effects of tumor cells has created the explosion of precision medicine. Integrate your flow cytometry, efficacy models, imaging, biomarker, and companion diagnostics to quickly advance to the next milestone–because patients can’t wait.
- Broad radiation oncology capabilities provide state-of-the-art services for either stand-alone or fully integrated projects with
- 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
Immuno-oncology treatment paradigms coupled with other targeted therapies and niche patient populations all require strong oversight to ensure appropriate safety management techniques and delivery of robust efficacy data. Our clinical professionals are currently supporting new approaches to precision medicine in solid tumors, working with cutting-edge therapies including combination immunotherapies and complex study designs across all phases. We conducted the studies that led to the approval of the very first checkpoint inhibitor, seeing it all the way through from Phase 1 through to marketing authorization and commercialization.
- Global, regional, and country-specific regulatory strategies to facilitate development of radiotherapeutics, radio diagnostics, 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.
- 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