Brian Abbott, MD
Vice President,
Therapeutic Area Medical Lead,
Oncology/Hematology
Oncology remains one of the most challenging therapeutic areas, with cancer clinical trials facing the lowest success rates. This underscores the need for innovative strategies and an oncology CRO partner who understands the complexities of this field and has deep experience across all stages of oncology drug development.
At Allucent, we are more than just an oncology CRO, we are your strategic partner in navigating the intricate landscape of oncology drug development. With expertise across all development phases from preclinical to post-marketing, we provide tailored solutions to overcome regulatory hurdles, patient recruitment challenges, and evolving research demands.
From early to late-stage cancer clinical trials, we drive efficiency, compliance, and data-driven success helping you bring life-changing therapies to patients faster.
Improving patient recruitment in Oncology clinical trials
Oncology clinical trials often face recruitment challenges due to stringent eligibility criteria and the need for specific patient populations. At Allucent, we address these issues by leveraging global reach, genetic data, and electronic medical records to identify the right patients quickly and efficiently.
As a specialized oncology CRO, we offer tailored solutions for oncology clinical research, supporting both hybrid and on-site oncology trials. Our expertise ensures streamlined recruitment while actively engaging patient communities to boost participation and retention.
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Expert oncology CRO Services for complex study designs
Oncology clinical trials require specialized expertise and complex study designs. As a trusted Oncology CRO, we excel in oncology research, implementing adaptive designs, basket trials, crossover designs, and single-arm trials to ensure precision and flexibility.
Our biostatistics and regulatory teams provide strategic guidance on cancer clinical trials, optimizing endpoint selection, data strategy, trial design and regulatory compliance. We also incorporate biomarkers into study designs to enhance precision medicine approaches, allowing for more targeted and effective treatments.
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Tackling Site Saturation and High Costs with our Oncology CRO services
At Allucent, we help you navigate the high costs and site saturation challenges by leveraging our extensive network of sites and strong relationships with key opinion leaders (KOLs). Our deep expertise in oncology clinical research and strong relationships allow us to gain valuable insights into site capabilities and patient recruitment potential, ensuring your cancer clinical trial is conducted at the most suitable locations.
Our expertise in conducting thorough feasibility assessments helps identify the right sites, avoiding oversaturated locations and optimizing trial execution. With our optimized site management and ongoing support, we ensure high-quality results while managing costs effectively.
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Overcoming Regulatory Challenges in Oncology drug development
Navigating the regulatory complexities of oncology clinical research and drug development requires expert guidance. We provide strategic support from early planning to post-approval, ensuring your Oncology clinical trial meet regulatory standards while optimizing fast-track approvals.
Our expert team, including former regulators from the FDA, EMA, and other global health authorities, provides strategic support in study design, endpoint selection, and data strategy to help you overcome the unique challenges of oncology drug development. With expertise in Project Optimus and Project Orbis, we streamline cancer clinical trials, securing breakthrough designations and ensuring compliance.
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The Allucent Center of Expertise (ACE) for oncology and hematology is powered by a dedicated team of experts in this therapeutic area, offering specialized knowledge and cutting-edge solutions across the entire oncology drug development process. The oncology ACE combines our oncology and hematology clinical trial operations excellence with deep expertise in regulatory strategy, clinical pharmacology, and biostatistics, providing comprehensive support from preclinical through to clinical development and beyond.
Pioneering Cancer Therapies for Tomorrow’s Cures
We have extensive experience with both traditional and cutting-edge therapies, including molecularly targeted agents, immunotherapies, and cell and gene therapies. We also specialize in combination therapies, and have substantial experience with anticancer vaccines, antibodies (monoclonal, bispecific, and ADCs), nanoparticle formulations, and modified chemotherapies to improve efficacy and patient outcomes.
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CELL AND GENE THERAPIES
Involvement in over 40 trials with autologous and allogenic cell products, including NK cells, T-cells, and oncolytic viruses. Multidisciplinary expertise in CGT trials.
Cell and Gene Therapy(CGT) trials are logistically challenging, requiring highly adept, multidisciplinary expertise. Allucent understands the unique needs of the small and mid-sized biopharma companies that are often at the forefront of development in this exciting field. Our project teams have been involved in more than 40 CGT studies and projects with both autologous and allogenic cell products. Besides trials that investigate natural killer (NK) cells, stem cells, dendritic cell, and T-cells, we have also worked on trials with oncolytic viruses. Learn more about out CGT expertise.
RADIOTHERAPIES
Supported regulatory approvals for radiolabeled proteins and Radium-223 in trials across Phases I-IV, working on NDA and MAA submissions.
We are highly experienced in performing trials with radiolabeled proteins and Radium-223 in neuroendocrine tumors and prostate cancer. Our team of experts works in the United States and Europe across Phase I-IV trials and has supported the regulatory approval of new drug applications (NDAs) at the FDA and marketing authorization applications (MAAs) at the EMA of radiolabeled proteins.
HORMONAL THERAPIES
Extensive work with therapies targeting hormone-driven cancers like breast and prostate. Expertise in aromatase inhibitors, selective estrogen receptor inhibitors, and more.
Altering the levels or activity of certain hormones can cause some cancers to cease growth and/or undergo cell death. We have performed studies with aromatase inhibitors, selective estrogen receptor inhibitors, and synthetic gonadotropin releasing hormone agonists as single therapies but also as part of combination therapies.
CHEMOTHERAPIES
Experience across Phases I-IV in combination therapies with targeted and immunotherapies, optimizing doses to reduce toxicity and improve outcomes. Over 20 studies in the past five years.
Advances in chemotherapy have evolved; it is no longer used solely as a monotherapy but can also be part of a combination therapy. Our clinical team has experience in chemotherapy combinations with targeted therapies and immunotherapies. In the last five years, our experts worked on over 20 studies ranging from Phases I to IV involving chemotherapy.
TARGETED THERAPY
Experience with complex adaptive trial designs and basket trials, across more than 115 studies. Expertise with antibodies, small molecules, and FDA approvals of targeted therapies.
Our clinical team has worked with targeted therapies in Phase I to IV studies, encompassing complex adaptive trial designs and basket trials. We are experienced in mechanisms of action including the inhibition of angiogenesis, histone deacetylase (HDAC), integrin receptors, poly ADP ribose polymerase (PARP), growth factors, and the cell cycle, to name a few. Allucent has supported more than 115 studies and projects and worked with antibodies and small molecules such as protein kinase inhibitors.
IMMUNOTHERAPIES
Participation in over 100 studies, combining immuno-oncology (IO) drugs with chemotherapy and targeted therapies. Proficient in irRC, iRECIST, and immune-related adverse events.
Our experts have worked on more than 100 studies and projects in hematologic malignancies and solid tumors and are well-versed in the different immune-related tumor evaluation criteria such as irRC and iRECIST, as well as immune-related adverse events (irAE). We have in-depth knowledge and hands-on experience with Immuno-Oncology drugs including antibodies, peptides, oligonucleotides, cell-based products, oncolytic viruses, and vaccines.
Comprehensive Expertise Across Traditional and Advanced Therapies in Oncology
- Deep expertise in early-phase, late-phase, and post-marketing studies, including compassionate use programs
- Proven track record with advanced therapy medicinal products (ATMPs), including gene, tissue, and cell-based medicines
- Successful collaboration on over 60 research projects involving cell and gene therapies and similar biologics in oncology
- Specialized knowledge in novel trial designs
Combining clinical expertise with research is essential for driving innovation and effective therapies. By aligning with scientific advancements and regulatory standards, we streamline development, accelerating safe treatments in hematology and oncology. This integration ensures faster patient access to transformative care while maintaining the highest safety standards.
Oksana Fabri, PhD, MD
Exec. Medical Director, Therapeutic Area Medical Lead, Hematology/Oncology
We are specifically designed to provide hematology and oncology CRO services to small and mid-size biopharma through every phase of drug development, from preclinical planning and IND submissions to the design and execution of Phase I-III trials, through marketing applications, to Phase IV and post-marketing initiatives to ensure ongoing success.
Preclinical Phase
Phase I
Phase II
Phase III
Phase IV
Preclinical Phase
Oncology Biomarker Discovery & IND Submissions
- Expertise in toxicology studies and pharmacokinetics to ensure a smooth transition to clinical trials
- Strong support for IND submissions with regulatory agencies (FDA, EMA, etc.)
- Deep experience in biomarker discovery and target identification to accelerate drug development
Phase I
First-in-Human Oncology Trials & Dose Escalation Studies
- Proven track record in oncology dose-escalation and safety-focused trials
- Expertise in designing and conducting adaptive trial designs
- Strong emphasis on site selection and early patient engagement for efficient trial execution
Phase II
Biomarker-Driven Patient Selection & Adaptive Dose-Ranging in Oncology
- Deep understanding of biomarker-driven patient selection to increase trial success rates
- Expertise in innovative trial designs (e.g., basket trials, single-arm trials) for faster efficacy evaluation
- Strong collaborations with KOLs and oncology research sites to ensure high-quality data and recruitment (key activity in Phase I as well)
Phase III
Global Pivotal Oncology Trials & Multi-Regional Regulatory Submissions
- Proven success in managing multi-center, global oncology trials with complex regulatory requirements
- Extensive experience with comprehensive trial management, including risk-based monitoring and data-driven decision-making
- Robust capabilities in handling regulatory submissions, including NDA/BLA and marketing approval strategies
Phase IV
Post-Marketing Oncology Surveillance & Lifecycle Management
- Comprehensive lifecycle management: Focused on pharmacovigilance for product safety and on ensuring compliance and inspection readiness
- Expertise in label expansions, new indications, and global approvals to extend product reach
- Support for market access and ongoing commercialization to ensure long-term success
Oncology Clinical Trials Require Multilayered Expertise
We have the hands-on knowledge to manage the complexities of cancer clinical trials and provide full-service support across various therapeutic areas. Our extensive experience across Early Phase through Phase III trials and beyond spans a wide range of oncology and hematology indications.
300+
Oncology & Hematology Studies
4860+
Global Sites
26725+
Oncology & Hematology Patients Recruited
60+
Countries
All-time years of experience
With global breadth and depth across a wide range of oncology and hematology indications, Allucent partners with biotech companies to bring innovative therapies to light.
SOLID TUMORS
- All comer (all solid tumors)
- Brain tumors (including GBM)
- Bladder cancer
- Breast cancer
- Cervical cancer
- Colorectal cancer
- Endometrial cancer
- Gastric cancer
- Head and neck cancer
- Liver cancer
- Lung cancer (including NSCLC)
- Melanoma
- Neuroendocrine tumors
- Ovarian cancer
- Pancreatic cancer
- Prostate cancer
- Renal cancer
- Sarcoma
HEMATO-ONCOLOGY
- All comer (all hemato-oncology)
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Chronic lymphocytic leukemia (CLL)
- Chronic myeloid leukemia (CML)
- Lymphoma
- Multiple myeloma
- Myelofibrosis
- Myelodysplastic syndromes
- Graft versus host disease
- Veno-occlusive disease
HEMATOLOGY
- Anemia
- Anticoagulant reversal
- Autoimmune hemolytic anemia
- Blood loss
- Essential thrombocythaemia
- Graft versus host disease
- Hereditary angioedema
- Hyperbilirubinemia (genetic)
- Neutropenia
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Sickle cell anemia
- Thrombotic thrombocytopenic purpura (TTP)
BIOLOGICALS
- Antibodies (e.g., monoclonal, bi-specific, antibody drug conjugates (ACDs), checkpoint inhibitors)
- Peptides
- Cell-based
- Autologous & allogenic (e.g., dendritic cell (DC), natural killer (NK), T cell, stem cell)
- Hormonal (e.g., hormone receptor inhibitors, liposomal corticosteroids)
- Vaccines (e.g., bacterial vaccines, DNA vaccines, peptide vaccines, RNA vaccines, tumor-derived vaccines)
- Oncolytic viruses
- Radiolabeled compounds
OLIGONUCLEOTIDES
- Antisense oligonucleotides
- miRNA compounds
SMALL MOLECULES
- Chemotherapy (e.g., alkylating agents, anthracyclines, antimetabolites, anti-microtubule agents, taxanes, topoisomerase inhibitors)
- Inhibitors (e.g., angiogenesis inhibitors, HDAC inhibitors, integrin receptor antagonists, PARP inhibitors, protein kinase inhibitors, tyrosine kinase inhibitors (TKIs)
Meet Some of Our Oncology and Hematology Experts
- Over 25 years of professional experience in hematology and oncology, including the past 6 years in the CRO industry
- Clinical trial strategy expertise for hemato-oncology trials and medical monitoring oversight
- Leadership of the oncology medical team at Allucent
Oksana Fabri, PhD, MD
Executive Medical Director,
Therapeutic Area Medical Lead,
Hematology/Oncology
- Over 16 years of experience in the fields of hematology, oncology, and stem cell transplantation
- Extensive knowledge of current treatment approaches, emerging therapies, and regulatory developments
- Offers expert guidance in medical oversight and strategic planning for clinical trials in related areas
Sandra Olthof
Executive Director,
Global Operations Head,
Oncology/Hematology
- 15+ years of industry experience, with extensive
experience in oncology clinical research - Highly skilled in clinical project management and project oversight, focusing on clinical trial delivery
- Extensive expertise in global (haemato-) oncology clinical studies, subject matter expert in dose escalation studies
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White Papers
CAR T Therapy: Overcoming Limitations and Reshaping Treatment of Hematologic Malignancies
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Frequently Asked Questions About Oncology CRO Services
An oncology CRO is a clinical research organization that helps biotech and pharmaceutical companies develop cancer treatments. It supports study design, regulatory submissions, site selection, patient recruitment, data management, and clinical trial oversight. Oncology CROs work across different trial phases to help sponsors bring new cancer therapies to patients safely and efficiently.
Allucent provides expert guidance on oncology clinical trial designs, including complex approaches such as adaptive trials, basket studies, and biomarker-driven protocols. Our clinical strategy, medical, biostatistics, clinical pharmacology, and regulatory experts collaborate on endpoint selection, patient populations, dosing strategies, and site feasibility to develop scientifically sound, operationally feasible studies aligned with health authority expectations.
An oncology CRO supports early-phase oncology trials by helping sponsors evaluate safety, tolerability, dosing, pharmacokinetics, and preliminary antitumor activity. Oncology CRO services include regulatory strategy and health authority interactions, site feasibility and investigator selection, clinical operations, medical monitoring, and data management and analysis. Global operational expertise and data-informed recruitment strategies support enrollment and trial execution, while study findings inform dose selection and decisions about further development.
Allucent has experience supporting oncology clinical trials across a broad range of solid tumors and hematologic malignancies. Our solid tumor experience includes breast cancer, prostate cancer, non-small cell lung cancer (NSCLC), head and neck cancer, ovarian cancer, colorectal cancer, glioblastoma, melanoma, pancreatic cancer, renal cell carcinoma, hepatocellular carcinoma, and neuroendocrine cancer. Our hematologic malignancy experience includes acute myeloid leukemia (AML), lymphoma, and multiple myeloma. This experience spans 295+ oncology studies.
Sponsors face a range of regulatory challenges in oncology drug development. Examples include keeping pace with evolving regulatory requirements and guidance, selecting endpoints that support approval, addressing FDA’s dose optimization expectations under Project Optimus, and establishing evidence for biomarker-defined patient populations. Companion diagnostics, accelerated approval pathways, and differing regulatory expectations across regions can add complexity. Allucent helps sponsors address these challenges through regulatory strategy, health authority interactions, and submission preparation across global markets.
Allucent has supported 295+ oncology clinical studies across 4,645+ study sites in 60+ countries, involving more than 26,375 patients. This experience spans a broad range of solid tumors and hematologic malignancies.
Allucent supports development across a broad range of oncology and hematology therapies. Examples include chemotherapies, hormonal therapies, targeted therapies such as antibody-drug conjugates (ADCs), immunotherapies, cell and gene therapies such as CAR-T and TCR-T, and radiotherapies, including radiopharmaceuticals. Our experience includes small molecules, biologics, and oligonucleotide therapies.