Oncology and Hematology icon

Oncology trials require oncology experts.

Sound decision-making demands an integrated approach. With more than 30 years of experience delivering solutions globally for small and emerging biopharma, CATO SMS understands how to develop and implement the right strategy throughout the lifecycle of your product. From study startup to trial execution, we’re adept at overcoming the challenges routinely appearing in complex therapeutic areas like oncology. Integrated regulatory, clinical, and scientific expertise and a collaborative approach are key to wise decision-making across interrelated processes. Our multidisciplinary team tackles your toughest challenges with confidence and precision by optimizing clinical strategy and conducting each trial with marketing approval or exit strategy in mind.

Small and midsize companies need the right partner.

Oncology remains the therapeutic area with the lowest success rate in clinical trials, underscoring the need for innovative approaches and a partner with deep experience in this fast-evolving, complex field.

As a specialized clinical solutions company primarily partnering with small to midsize biopharma, CATO SMS excels at designing and executing oncology and hematology clinical trials. Our expertise encompasses all development phases (I-IV), solid tumors, and hemato-oncology indications. We provide guidance and insight in optimized clinical strategy, choice of endpoints based on the mode of action or tumor biomarkers, patient selection, feasibility studies, up-to-data trend analysis, and results reporting.

A patient-centric approach is assured by clinical development informed by the special needs of oncology patients and supported by state-of-the-art enabling technologies, ranging from digital patient engagement strategies and eConsent to sensor technology and implementation.

We are working at the forefront of oncology projects with cutting-edge treatments. Our network of medical and research experts can assist you with the right advice and insights. Our regulatory perspective is crucial to planning for study design, choice of endpoints, data strategy, and so much more and is provided as a key element of our strategic guidance for early planning and continuing through post-approval.

Partnerships are essential on many levels. CATO SMS has built a reliable collaborative network comprising the world’s top clinical sites, investigators, and key opinion leaders. These leaders facilitate the selection of the most suitable countries in which to locate your trial while selecting optimal sites for patient recruitment.

  • State-of-the-Art Technologies
  • Strategic Guidance for Early Planning
  • Novel Trial Designs and Solutions
  • KOL Network
  • Regulatory Support & Consulting
  • Patient Centricity
  • Partnering Models
  • Highly Specialized Trial Execution

Oncology trials require oncology experts.

Supporting drug development for cancer treatment requires multilayered proficiency: in the science, in the different aspects of clinical research, and in the ability to understand the emotional and physical experience of trial participants. Every phase of a clinical trial is different. Beginning with Early Phase through Phase II and III and beyond, CATO SMS has deep expertise in many indications and therapeutic classes and is confident in taking on the full complexity inherent in cancer research. Our extensive experience with full-service clinical trials and consulting projects has provided us with ample hands-on knowledge of a wide variety of indications.

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


  • All comer (all hemato-oncology)
  • Acute lymphoblastic leukemia (ALL)
  • Acute myeloid leukemia (AML)
  • Chronic lymphocytic leukemia (CLL)
  • Chronic myeloid leukemia (CML)
  • Lymphoma
  • Multiple myeloma
  • Myelodysplastic syndromes
  • Graft versus host disease
  • Veno-occlusive disease


CATO SMS’ oncology experience over the last 5 years includes these indications (each with 5 or more studies):

Indication with >5 studies



  • 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


  • 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))

A commitment to delivering therapies that can deliver cures.

The CATO SMS team has many years of experience in traditional therapies as well as the promising new therapeutic classes including molecularly targeted agents, immunotherapies, and cell and gene therapies. We are also well-versed in different combination therapies. We have substantial experience in anticancer vaccines, antibodies (monoclonal, bispecific, and ADCs); nanoparticle formulations; metabolic regulators; and modified chemotherapies for enhanced efficacy.

Our experts have deep knowledge of the novel trial designs emerging in modern practice, specifically in oncology and rare diseases. We have an impressive track record with advanced therapy medicinal products (ATMPs), medicines for human use based on genes, tissues, or cells. CATO SMS has collaborated on more than 60 research projects involving cell and gene therapy products and similar biologics for oncology, as well as several other therapeutic areas.

Beyond our specialization in Early Phase trials, we have substantial experience in conducting Late Phase, pivotal, and post-marketing trials, as well as compassionate use/early access programs. From clinical study design to clinical trial management, medical writing, clinical data management, and more, you need CATO SMS as a partner.


At CATO SMS we recognize that cancer research continues to improve available treatment options. Chemotherapy has been evolving and is no longer simply used as a monotherapy modality but can also be part of a combination therapy modality. This approach allows for the use of optimal drug doses, resulting in decreased toxicity effects. It also reduces drug resistance and provides better outcomes for patients. Our clinical team has experience in combinations of chemotherapy with targeted therapies and/or immunotherapies. In the last 5 years, our experts worked on >20 studies ranging from Phase I to IV involving chemotherapy.


Cell & Gene Therapies
CAGT trials are logistically challenging, requiring highly adept, multidisciplinary expertise. CATO SMS understands the unique needs of the small and mid-size biopharma companies that are often at the forefront of development in this exciting field. Our project teams have been involved in more than 40 CAGT 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.


Hormonal Therapies
Several types of cancers (e.g., breast and prostate) use hormones to grow. Altering the levels or activity of certain hormones can cause these 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.


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 IO drugs including antibodies, peptides, oligonucleotides, cell-based products, oncolytic viruses, and vaccines. This experience encompasses testing these drugs as combination therapy with classic chemotherapy and targeted therapy.


Targeted Therapy
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. CATO SMS has supported more than 115 studies and projects and worked with antibodies and small molecules such as protein kinase inhibitors. Our regulatory team has been involved in FDA approval of targeted therapies.


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.