Oncology and Hematology icon

Oncology trials require oncology experts.

The development of anticancer drugs is more difficult and has a lower success rate than in other indications. You need a partner that has both deep and current experience executing projects in the fast evolving and complex field of oncology. Our proven center of excellence in oncology provides you with guidance and insight on optimized clinical strategy, choice of endpoints based on the mode of action or tumor biomarkers, patient selection, feasibility studies, up-to-date trend analyses, and result reporting.

As a specialized clinical solutions company, primarily partnering with small to midsize biopharma, our experts excel at designing and executing oncology and hematology clinical trials, covering all development phases (I–IV), solid tumors and hemato-oncology indications, and a wide spectrum of drug modalities and therapeutics.

We are working at the forefront of oncology projects with cutting-edge, innovative cancer treatments and have substantial experience in anticancer vaccines, antibodies (monoclonal, bispecific, and ADCs), nanoparticle formulations, metabolic regulators, as well as (modified) chemotherapies for enhanced efficacy.

CATO SMS’ extensive experience with full-service clinical trials and consulting projects has provided us with ample hands-on experience with a wide variety of immunotherapies, including (DNA) vaccines, immune stimulating peptides, antibodies, immune checkpoint inhibitors (ICIs), and cell and gene therapies. Several of the programs we worked on included combinations with PD-L1 inhibitors.

We have an impressive track record with advanced therapy medicinal products (ATMPs), which are medicines for human use that are based on genes, tissues, or cells. CATO SMS has collaborated on over 60 research projects involving cell and gene therapy products and similar biologics for oncology as well as several other therapeutic areas.

CATO SMS is your expert partner when it comes to early phase oncology trials. We are specialized in the Phase I/II oncology setting, comprising the majority of our trial portfolio. In early phase oncology trials, detailed data is collected at a limited number of academic sites, and oncology know-how is key. Due to their complex nature, our early phase trials are monitored intensively by our oncology CRAs and managed by our experienced PMs. Many of our full-service Phase I/II oncology trials are first-in-human trials, with a dose-escalation trial design and/or other multifaceted procedures or adaptive trial designs.

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. We understand the importance and critical route toward marketing approval and we design and conduct each trial with your marketing approval or exit strategy in mind. From clinical study design to clinical trial management, medical writing, clinical data management, and more ⁠— you know your team is bringing their best. You need a partner who does, too. You need CATO SMS.

Oncology Expertise

Our proven center of excellence in oncology gives you insights and results from startup to completion.

  • With our focus in oncology, we have worked on oncology projects for a wide range of clients; many who return for continued collaboration. We have the in-depth therapeutic knowledge and hands-on experience to meet your challenges and seize opportunities before or during study conduct.
  • We are on top of current scientific and clinical developments in the cancer therapy field with the aim to support you in transforming cancer care. Clinical experience and market understanding are crucial to discovering and leveraging the full potential of your oncology compound.
  • CATO SMS has built a reliable collaborative network in the oncology field consisting of internationally renowned, experienced, and well-motivated clinical sites, investigators, and key opinion leaders. Our extensive network facilitates the selection of the most suitable countries in which to place your trial while selecting optimal sites for patient recruitment.
  • Due to their complex nature, our trials are monitored intensively by our dedicated oncology CRAs, who are well versed in tumor-specific evaluation criteria and/or immune-related criteria such as RECIST 1.1, (i)RANO, irRC, iRECIST, mRECIST.

Patients are relying on you to discover lifesaving treatments; you can rely on us to deliver the therapeutic, operational, and organizational insights your oncology trials need.

We know how important your product is to you and the patients who are waiting.