Advancing Hematology
With a long history of advancing hematology research, we’re your partner in the rapidly changing world of hematopoietic stem cell transplantation (HSCT) and cellular and gene therapies.
We’re particularly proud to have partnered with a client to successfully run Phase I and Phase II trials, establishing dosing and proof of concept for a compound with the potential to become the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).
Building on that research, we conducted a Phase III trial in the United States, Latin America, Europe and Asia across 50 sites. Today, the compound has obtained Breakthrough Therapy Designation and shows great promise as a lifesaving treatment option for bone marrow transplant candidates.
Together, we can deliver new discoveries and novel applications, however complex the challenge.
Adam Mendizabal, Ph.D.
We look forward to talking with you, learning more about your specific goals and determining how we can help you.
Clinical Research Experience
Global Hematology Expertise
Over 25 years, and through our strong relationships with leading investigators and institutions, our hematology clinical research professionals have become adept at designing and conducting complex hematology clinical trials.
We collaborated on our first major transplantation trial in T-cell depletion in 1995. Since then, we’ve worked with more clients to enrich the understanding of hematology, and to test new and existing therapies.
Our broad-spectrum experience in blood and marrow disorders spans research in lymphoma, leukemia, multiple myeloma, hemophilia, myelodysplastic syndrome, thalassemia, aplastic anemia and sickle cell disease. Our unique hematology, oncology and immuno-oncology experience has supported groundbreaking work.
Hematopoietic Stem Cell Transplantation (HSCT)
Collaborating with clients pursuing practice-changing contributions to medicine and human health, we’ve carried out research on graft sources, conditioning regimens, infection prophylaxis, treatment and prophylaxis for acute and chronic graft versus host disease, quality of life and toxicity.
Cellular Therapy
Our expertise includes complex hematology study designs, unique regulatory strategy challenges and understanding central and local manufacturing considerations. We also have unique insights from our experience leading the Production Assistance for Cellular Therapies (PACT) coordinating centers.
US and Global Operations
We know that strong, collaborative relationships empower significant advances in hematology research. We continue to grow our global strategic partnerships with top institutions, investigators and thought leaders.
Patient Outreach and Education
We are committed to outreach, education and the need to engage groups focused on rare and critical diseases. For example, the valuable insights gained from our work with the National Heart, Lung, and Blood Institute (NHLBI) is being used to support accelerated development of potentially curative genetic therapies.
Our collaborations have enabled publication of more than 100 papers from 125+ global studies in Hematology, including cell therapy and HSCT. Our 20+ year relationship with the National Institute of
Health-funded Blood and Marrow Transplant Clinical Trials Network (BMT CTN) has generated insights that can be applied to advance the study of hematology and transplantation.
There’s so much more to be discovered in hematology, particularly cellular/gene therapy, liquid tumors, and transplantation. To enable true medical advancement, we’re learning from experience, working in collaboration and sharing an ambitious vision.
Supporting the Full Continuum of Clinical Research
- IND writing
- Trial design, statistical analysis plan, protocol development, and implementation
- Statistical study design and analysis
- Clinical trial oversight and monitoring
- Site identification, management and monitoring
- Laboratory and repository management
- Data system development and management
- Data and Safety Monitoring Board (DSMB) support
- Regulatory strategy
- Administrative support
