Hematology CRO Services
Enroll on schedule with patient-first strategies for hematologic conditions
Hematology studies face a range of challenges, including working with vulnerable patient groups, managing intricate protocols, and navigating unpredictable patient responses. Ensure your trial stays on track with PSI’s unmatched site relationships and a relentless commitment to on-time delivery.
14
drug approvals
4,200
hematology sites in 60 countries
93%
on-time enrollment
Hematology Pivotal Trial Solutions
Precision medicine in hematology is evolving rapidly, with significant shifts presenting new considerations for the entire treatment landscape:
- In hematology-oncology, targeted therapies, such as BTK and BCL-2 inhibitors and immunotherapies like CAR T-cells, have markedly enhanced treatment outcomes, especially for common B-cell malignancies like CLL.
- In conditions like hemophilia, groundbreaking advancements — such as gene therapies, monoclonal antibodies, and extended half-life factor products — are redefining treatment approaches.
- Meanwhile, hematopoietic stem cell transplantation (HSCT) remains a cornerstone for many hematologic conditions, and advances in techniques and treatment of HSCT complications are strengthening outcomes alongside emerging therapies.
PSI helps you capitalize on these shifts with dedicated support for pivotal trials in hematology-oncology, hemophilia and other bleeding disorders, and other classical and malignant hematology conditions. Achieving trial milestones in these indications requires a highly tailored approach and specialized medical expertise. Your CRO must be adept at managing sites running studies involving novel endpoints, intricate treatment sequences, and specialized labs, among other challenges.
Sponsors choose PSI for our extensive global site relationships and proven success with complex trial designs across indications. With PSI at your side, you gain assurance and strategic advantage for every phase of your hematology program.
PSI Hematology Highlights
- 14 hematology drug approvals, including one of the first-ever gene therapies
- 120 studies across 20+ blood diseases
- 12 KOLs specializing in hematology-oncology/hematology on our Scientific Advisory Board​
- 10 in-house hematologists/oncohematologists​
- Cell therapy and hematology-oncology nurses on the site support team
- Long-tenured CRAs and PMs maintaining relationships at hematology sites
On-time delivery in hemophilia, blood cancers, rare bleeding disorders, and more
PSI Hematology & Hematology-Oncology Expertise
Indications
Leukemias
- Acute
- Acute lymphoblastic leukemia (ALL)
- B-cell lineage
- T-cell lineage
- Acute myeloid leukemia (AML)
- With recurrent genetic abnormalities (e.g., t(8;21), FLT3-mutated)
- Therapy-related or secondary AML
- Biphenotypic acute leukemia (BAL) or mixed-phenotype acute leukemia (MPAL)
- Acute lymphoblastic leukemia (ALL)
- Chronic
- Chronic lymphocytic leukemia (CLL)
- Chronic myeloid leukemia (CML) (BCR-ABL1 positive)
Lymphomas
- Hodgkin lymphoma
- Classical Hodgkin lymphoma
- Nodular sclerosing Hodgkin lymphoma
- Mixed cellularity Hodgkin lymphoma
- Lymphocyte-depleted classic Hodgkin lymphoma
- Lymphocyte-rich classic Hodgkin lymphoma
- Nodular lymphocyte-predominant
- Classical Hodgkin lymphoma
- Non-Hodgkin lymphoma (NHL) – common subtypes
- Diffuse large B-cell lymphoma (DLBCL)
- Follicular lymphoma
- Marginal zone lymphoma
- Mantle cell lymphoma
- T-cell lymphomas (e.g., anaplastic large cell lymphoma, cutaneous T-cell lymphoma)
Plasma cell and monoclonal gammopathies
- Monoclonal gammopathy of undetermined significance (MGUS)
- Smoldering myeloma
- Multiple myeloma
- Waldenström’s macroglobulinemia
- Light chain amyloidosis
Myeloid/erythroid disorders
- Myelodysplastic syndromes (MDS)
- With defined cytogenetic/molecular abnormalities
- Myeloproliferative neoplasms (MPN)
- Polycythemia vera (JAK2-mutated)
- Essential thrombocythemia (ET)
- Primary myelofibrosis (PMF)
- Secondary/post-MPN myelofibrosis
- Erythroid disorders
- Iron deficiency anemia
- Thalassemias (α, β)
- Sickle cell disease
- Other hemoglobinopathies
Bone marrow failure syndromes
- Aplastic anemia
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Inherited marrow failure syndromes (e.g., Fanconi anemia)
Hemostatic disorders
- Inherited bleeding and clotting disorders
- Hemophilia A & B
- Von Willebrand disease
- Rare factor deficiencies (VII, XI, fibrinogen)
- Platelet function disorders (Glanzmann thrombasthenia, Bernard-Soulier)
- Acquired bleeding and clotting disorders
- Immune thrombocytopenia (ITP)
- Thrombocytopenia associated with systemic disease
- Transplant-associated thrombotic microangiopathy (TA-TMA)
Rare hematologic syndromes
- Hemophagocytic lymphohistiocytosis (HLH)
- Others defined by molecular pathophysiology
Drug Classes
- Antineoplastic agents/Anti-cancer treatments (including immunotherapies):
- Inhibitors:
- DNA inhibitors
- Microtubule inhibitors
- Mitotic inhibitors
- TKI: Tyrosine kinase inhibitors
- Enzyme inhibitors (e.g., EZH2, protease, telomerase)
- Other inhibitors: (e.g., histone deacetylase, nuclear transport)
- Other traditional chemotherapy agents: e.g., alkylating agents, antimetabolites, plant alkaloids
- Antibody Drug Conjugates (ADCs)
- Bispecific antibodies
- Chimeric and monoclonal antibodies (including humanized and fully human), CAR
- Novel small molecules: e.g. Novel TKI
- Fusion and therapeutic proteins
- Inhibitors:
Drug Classes
- Antihemorrhagics & coagulation modifiers:
- Recombinant factors (e.g., Factor VIII, IX, VII)
- Cell and gene therapies
- Antiplatelet agents
- Blood substitutes
- Anti-infective agents:
- Antiviral agents
- Antifungal/antimycotic agents
- Antibiotic agents
- Detoxifying and targeted adsorbent drugs
- Immunostimulants and Immunosuppressants
- First in human
- First in class
- Orphan drugs
Patient Populations
- Adult
- Pediatric
- Post stem cell transplantation
- Immunodeficient
Efficiency, Clarity, and Confidence in Your Hematology Approach
Running a global hematology study means selecting from among thousands of potential sites — an overwhelming process with high stakes for timelines and patient outcomes. The right site relationships and multidisciplinary support can determine whether enrollment stays on track or falls behind.
PSI’s SYNETIC™ combines both internal and external data on hematology sites globally, delivering actionable real-time insights on site performance, capacity, and recruitment by indication. Paired with VISIONAL™ for strategic planning, PSI enables you to efficiently model and compare hundreds of enrollment scenarios, budgets, and success probabilities in minutes.
These AI-powered insights validated by board-certified hematologists provide clarity and assurance in selecting study geographies and timelines, empowering you to choose only the most effective sites for your protocol. This minimizes enrollment risks and delays, increasing the likelihood of overall study success.
Support Infrastructure to Match Site Capabilities
Hematology trials often overwhelm sites with data and the need for collaboration across several departments: labs, transfusion, infusion, cell and gene therapy, radiology, and more. Supporting clear communication across departments enables sites to establish a more seamless patient pathway, ensuring enrollment and delivery remain on track.
PSI fills the gaps that often remain unaddressed during these studies. We proactively identify site needs that hinder progress and deliver tailored support for consistent trial execution.
Latest Hematology Resources
Get in touch with PSI’s hematology team
Hematology trials require a multifaceted approach, with seamless communication driving trial success. Find your perfect team of hematology experts today and propel your pivotal study to success.
Trusted to Deliver
When you partner with PSI, you work with a team recognized by independent industry organizations and sponsor surveys for what matters most in clinical research: expertise, consistent operational excellence, and reliable delivery.
