TD2 is a leading full-service oncology CRO, offering clinical trial services for hematology-oncology trials and blood cancer drug development. Our team has extensive experience in hematologic malignancies, including leukemia, lymphoma, multiple myeloma, AML, MDS, and myelofibrosis. We bring a strong track record across diverse therapeutic approaches, supporting trials for innovative therapies in blood cancers. Our expertise in hematologic trials allows us to address the unique complexities of these cancers, delivering rigorous, high-quality studies that expedite the path from discovery to treatment.
TD2’s Clinical Hematology-Oncology Experience
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Contact our experts to learn more about our clinical trial services for hematologic malignancies.
Clinical Trial Services for Hematology-Oncology Indications
- Leveraging Flow Cytometry: Hematologic malignancies present unique evaluation challenges. While solid tumors like lymphomas are often assessed using RECIST criteria, diseases such as leukemia and MDS require specialized approaches. At TD2, we utilize advanced molecular analyses, including our extensive in-house clinical flow cytometry services, to provide precise cellular profiling and assess disease progression and therapeutic response with unparalleled accuracy.
- Protocol Design and Optimization: Development of clinical trial protocols that optimize scientific rigor and efficiency for hematologic oncology, addressing unique considerations in blood cancer research. Our protocols span leukemia, lymphoma, and multiple myeloma trials, incorporating oncology drug safety studies, bioinformatics in oncology research, and specialized endpoints for hematologic cancers.
- Regulatory Strategy and Submission: Comprehensive guidance on navigating complex regulatory requirements for hematologic malignancy clinical trials, including compliance for cell and gene therapies and innovative hematology-oncology treatments. Our team provides full support through submission processes and oncology pharmacovigilance, ensuring alignment with the latest industry standards.
- Site Selection and Management: Hematologic malignancy patients are often treated at specialized hematology-oncology clinics or require inpatient care, unlike solid tumor patients. TD2 leverages years of experience and established relationships with key treatment centers to identify and engage optimal sites, ensuring access to eligible patients and enabling successful trial outcomes.
- Patient Recruitment and Retention: Focused strategies for recruiting and retaining diverse patient populations, specifically for challenging hematologic oncology trials in conditions like AML, MDS, and myelofibrosis. We leverage targeted methods to enhance adherence and continuity in oncology study designs, ensuring robust data and trial success.
- Safety Monitoring and Data Management: Comprehensive data management and safety monitoring systems to track drug efficacy studies for hematologic disorders. TD2 ensures rigorous standards for cancer treatment research, supporting regulatory submissions and informed decision-making throughout oncology drug development.
- Imaging and Biomarker Integration: Advanced integration of imaging and hematology-oncology biomarkers to assess treatment response and drug effects. Our team incorporates leading biomarker validation techniques and imaging modalities to enhance clinical research insights for hematologic malignancies.
- Quality Assurance and Compliance: Adherence to rigorous quality assurance and compliance standards across all processes, including GCP and bioinformatics in oncology research.
TD2’s Chief Medical Officer, Dr. Alan M. Miller, MD, PhD, is a distinguished leader in hematologic oncology with a career dedicated to advancing blood cancer treatment and cellular therapies. His extensive experience includes directing blood and marrow transplant programs at the University of Florida and Tulane University, where he served as the founding director. While serving as Cancer Center Director at the Baylor Sammons Cancer Center, Dr. Miller played a key role in pioneering antibody drug conjugates (ADC) in Hodgkin's Lymphoma and participated in CAR-T trials in non-Hodgkin's Lymphoma, driving forward innovative treatment options for blood cancer patients.
Dr. Miller has also served as a principal investigator for the Southwest Oncology Group (SWOG) at three institutions, contributing to national research initiatives on leukemia, lymphoma, multiple myeloma and transplantation. His membership in the Centers for Blood and Marrow Transplant, where he served on the host committee focused on leukemia, lymphoma, and graft-versus-host disease, highlights his impact on the field. A strong advocate of combining immune-based therapies with traditional approaches, Dr. Miller’s expertise guides TD2’s hematologic oncology programs, shaping our approach to clinical trial design and development of advanced therapies for blood cancers.
