Malignant hematology CRO

Accelerate enrollment and adapt to evolving therapies with an experienced malignant hematology CRO

Hematological malignancies are extremely diverse and complex. Their trials require deep therapeutic expertise, operational excellence, insight into the patient experience, and specialized sites capable of managing serious adverse events and long-term follow-up. At Parexel, we’re ready to meet those needs as your malignant hematology CRO, continuing to remain flexible to meet patient’s needs as treatments rapidly evolve.

Our franchise brings together physicians, regulatory strategists, and operational leaders who anticipate and mitigate the challenges of your trials. We accelerate your timelines without compromising scientific integrity, leveraging data-driven feasibility models, biomarker and lab integration capabilities, and patient-centric operational frameworks. We also maintain one of the industry’s strongest global site networks, which includes high-performing hematology centers with experience in CAR-T cell therapies, gene editing, bispecific antibodies, and next-generation targeted agents.
 

Acute myeloid leukemia

Acute myeloid leukemia (AML) is one of the most logistically and scientifically complex research areas in malignant hematology. Rapid disease kinetics, the urgent need for treatment, and other complexities add to the challenge. Parexel remains at the forefront of AML treatment.

Our global lab and biomarker integration capabilities support rapid turnaround of cytogenetic, molecular, and MRD assays, which are critical for risk stratification, cohort assignment, and adaptive designs. We have extensive experience with novel AML modalities, including FLT3, IDH1/2, menin inhibitors, antibody drug conjugates, bispecifics, and early-phase immunotherapies, enabling us to anticipate their safety patterns and operational needs. Through integrated medical monitoring, risk-based safety oversight, and proactive site readiness frameworks, we ensure trials are executable even with demanding timelines and AML’s inherent volatility.

Multiple myeloma

Multiple myeloma trials place a heavy burden on patients. Patients often visit various doctors before learning the cause of their condition, undergo a series of invasive tests, and more. Understanding these patients’ needs and tackling the complexities of these trials with therapeutically aligned operations are vital for success.

We’re equipped to help as an experienced malignant hematology CRO. Our patient-centric operational models, which include decentralized elements, remote safety monitoring, and caregiver support frameworks, help reduce burden for patients who often face chronic treatment, cumulative toxicity, and frequent clinic visits. Our medical team also guides protocol design to ensure that eligibility criteria, endpoints, and sequencing assumptions reflect real-world practice and evolving treatments. We leverage a curated global network of high-performing myeloma centers, including CAR-T and bispecific experienced sites, capable of managing intensive safety monitoring, complex logistics, and long-term follow-up.

Myelodysplastic syndromes

Myelodysplastic syndromes (MDS) present a uniquely complex research environment due to heterogeneity, biological overlap with AML, and predominance in older, comorbid patients, which requires an incredibly nuanced approach to clinical development.

At Parexel, our advanced biomarker and molecular integration capabilities support next-generation sequencing, cytogenetics, and emerging molecular classifiers, which increasingly guide risk stratification and cohort assignment for MDS. We have extensive experience with novel MDS modalities, including hypomethylating agent combinations, targeted therapies (such as TP53 and splicing factor mutations), TGF-β pathway inhibitors, and early-phase immunotherapies. Our feasibility team is able to accurately forecast patient enrollment across risk categories through epidemiology, competing trial analytics, and site-level performance data. Additionally, our operational teams are trained in MDS to coordinate frequent lab monitoring, bone marrow sampling logistics, and centralized molecular testing, while our medical monitoring and safety oversight frameworks ensure early detection of progression to AML or treatment-related cytopenias.

B-cell lymphomas

B-cell lymphoma trials face substantial complexity due to rapidly evolving treatments and the need to manage both indolent and highly aggressive subtypes. The wide array of variations, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and transformed lymphomas, all have distinct biologies, prognostic markers, and response kinetics, requiring precise protocol design and endpoint selection.

At Parexel, we address those complexities with deep therapeutic expertise and a global network of high-performing lymphoma centers, including CAR-T and bispecific-experienced sites that can manage intensive safety monitoring, complex logistics, and long-term follow-up. Our operational teams are trained specifically in lymphoma, coordinating imaging schedules, centralized pathology review, and safety oversight for immunotherapy-related toxicities. Through integrated medical monitoring, risk-based safety frameworks, and proactive site readiness, we make sure your B-cell lymphoma trials are executable even as therapeutic paradigms rapidly evolve.

T-cell lymphomas

T-cell lymphomas include peripheral T-cell lymphomas (PTCL), cutaneous T-cell lymphomas (CTCL), and rare, aggressive entities. They pose unique challenges for clinical trials because they’re relatively rare, biologically heterogeneous, and often carry a poor prognosis, without many lineage-specific standards of care.

We tailor our operational models to tackle the challenges of rare, high-risk, immunotherapy-intensive malignancies. Our medical team and regulatory strategists work closely on protocol design to ensure that eligibility criteria, stratification factors, and endpoints reflect the biological diversity of disease entities such as PTCL and CTCL. We leverage curated global networks of centers experienced in T-cell lymphoma, including sites with expertise in advanced CTCL, CD30-positive disease, and transplant-eligible populations, to improve patient identification and accelerate enrollment despite low incidence. Our operational teams are trained in T-cell lymphoma to coordinate complex safety monitoring, imaging, pathology review, skin-specific assessments, and our risk-based medical monitoring frameworks help detect early signals of toxicity or progression in aggressive subtypes. 

Chronic lymphocytic leukemia and small lymphocytic lymphoma

The chronic, often indolent natures of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), and their predominance in older, comorbid patients, create many challenges. Operationally, CLL/SLL trials require sustained, years-long monitoring, MRD-driven endpoints, and careful sequencing assumptions when there are multiple available lines of targeted therapy and chemo-free regimens.

At Parexel, we offer deep expertise as a hematology CRO and curate our operational models to chronic malignancies. We ensure our eligibility criteria, endpoints, and sequencing assumptions reflect real-world CLL/SLL practices, including continuous BTK inhibition, time-limited venetoclax-based regimens, and MRD-guided strategies. Our operational teams are trained in CLL/SLL to better coordinate long-term safety monitoring, MRD assessments, and the management of complex comorbidity and drug interaction profiles. Additionally, we support adaptive designs and long-term follow-up by designing our integrated medical monitoring and risk-based safety frameworks to detect early signals of toxicity, intolerance, or resistance.

Myelofibrosis

Myelofibrosis (MF) trials come with many complexities. The disease is rare, predominant appears in older, cytopenic patients, and includes a variety of symptoms that greatly impact quality of life and survival. Trial design must account for heterogeneous driver mutations (e.g., JAK2, CALR, and MPL), variable risk categories, and two therapeutic goals: symptom control and modification of disease trajectory. The evolving landscape of approved JAK inhibitors and emerging combination strategies further complicates cohort definition, sequencing assumptions, and endpoint selection, especially as spleen volume reduction is increasingly seen as a surrogate for survival.

We have the experience and expertise as a malignant hematology CRO to address these complexities. Our medical and regulatory teams work closely to ensure eligibility criteria, endpoints, and biomarker strategies match the realities of MF trials, including JAK inhibitor selection across phenotypes and transplant-related pathways. Our global network of MF centers are experienced in the use of JAK inhibitors, splenomegaly management, and allogeneic transplant, empowering realistic enrollment projections despite low incidence and complex comorbidities.