TD2 is a leading Contract Research Organization (CRO) specializing in oncology, offering comprehensive clinical trial management services for radiolabeled pharmaceuticals. Radiopharmaceuticals, which combine radioactive isotopes with biological molecules, have become transformative tools in both the diagnosis and treatment of cancer. However, advancing these therapies into clinical trials presents unique challenges, including complex regulatory requirements, specialized imaging needs, patient recruitment hurdles, and stringent safety protocols. As the field evolves there's a growing need for experienced partners to navigate these complexities. With over 15 years of experience and a track record of executing successful radiopharmaceutical trials, TD2's oncology experts help mitigate risks, streamline processes, and ensure regulatory compliance, accelerating the development of these cutting-edge therapies.
TD2's Clinical Radiopharmaceutical Experience
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Contact our experts to learn more about our clinical trial services for radiolabeled pharmaceuticals.
Clinical Trial Services for Radiopharmaceuticals
TD2 provides a full suite of services tailored to support the development and execution of clinical trials for radiolabeled pharmaceuticals:
- Protocol Design and Optimization: Development of clinical trial protocols that consider the unique characteristics of radiopharmaceuticals, including radiolabeling stability, dosimetry, and biodistribution.
- Regulatory Strategy and Submission: Expert guidance on navigating the stringent regulatory requirements for radiopharmaceuticals, including approvals for novel theranostic agents that combine both diagnostic and therapeutic applications.
- Site Selection and Management: Identification of specialized clinical trial sites equipped with the necessary imaging technologies (such as PET and SPECT) and experienced in handling radiopharmaceutical agents.
- Patient Recruitment and Retention: Focused strategies to recruit patients with specific cancer types that can benefit from therapeutic uses of radiolabeled drugs, especially in rare and advanced malignancies.
- Safety Monitoring and Data Management: Continuous monitoring of radiopharmaceutical-specific safety concerns such as radiation exposure, along with data management that captures both therapeutic efficacy and diagnostic imaging outcomes.
- Imaging and Biomarker Integration: Seamless integration of advanced imaging modalities crucial for assessing the biodistribution, uptake, and efficacy of radiopharmaceutical agents.
- Quality Assurance and Compliance: Ensuring compliance with Good Clinical Practice (GCP) and radioactive material handling regulations to maintain high safety standards throughout the trial lifecycle.
Features and Benefits of Working with TD2:
- Oncology Expertise: As a CRO with a primary focus on oncology, TD2 offers unmatched insights into the challenges and opportunities in cancer drug development.
- Radiopharmaceutical Expertise: With a proven track record of managing seven clinical trials in radiopharmaceuticals, TD2 offers extensive experience and insights for your studies. Our expertise includes handling challenging isotopes like ⁶⁸Ga (Gallium-68).
- Comprehensive Trial Support: From protocol development to regulatory submissions, patient recruitment, and data management, TD2 provides end-to-end support for your clinical trials.
- Advanced Imaging Capabilities: Integration of imaging techniques essential to evaluating the efficacy of radiolabeled therapies.
- Global Reach: Access to top clinical trial sites worldwide, with experience managing international trials.
- Faster Time to Market: Streamlined processes and expert project management help reduce trial timelines, bringing therapies to patients faster.
- Regulatory Expertise: Navigating the complex regulatory landscape for radiopharmaceuticals with precision and experience.
- Quality and Compliance: Dedicated to ensuring the highest levels of compliance and quality control in every aspect of your clinical trial.
| Isotopes Used in Radiopharmaceutical Clinical Trials at TD2 |
|---|
| 89Zr |
| 212Pb |
| 111ln |
| 64Cu |
| 68Ga |
TD2 is your trusted partner for radiolabeled pharmaceutical clinical trials, offering unmatched oncology expertise and a proven track record in advancing cancer therapeutics. Reach out to learn how our team can help accelerate your next clinical trial.
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