In the United States (U.S.), cancer-related age-adjusted mortality rates significantly declined from 206 deaths per 100,000 persons (1995-1999) to 155 deaths per 100,000 persons (2014-2018). This encouraging trend is likely related to the sharp increase in approvals of oncology therapies by the U.S. Food and Drug Administration (FDA). More than any other therapeutic area, oncology trials and cancer research saw a greater number of fast track, accelerated, and priority approvals between 2000 and 2017. Of the 300 drugs approved by the U.S. FDA over the last 30 years, nearly 35% were from oncology clinical trials, reflecting the continuous need for new and novel therapeutics in cancer care.

During this same 30-year period, especially in the last few years, the reliance on oncology contract research organizations (CROs) has gradually expanded to all phases of cancer clinical trials. When collaborating with a high-quality CRO partner, cancer research sponsors can benefit from improved data reliability and integrity, in addition to consistently meeting rigorous industry and protocol compliance standards. However, some CROs stand out above others, particularly in the field of oncology where successful clinical trials must overcome several unique challenges.

In this article, we will discover the top five leading oncology-focused CROs for 2025, presented in no particular order. Continue reading to learn how these top specialty CROs are advancing cancer research with innovative trial designs, specialized expertise, and cutting-edge technology.

1. Medelis Oncology CRO

Founded: 2003

Headquarters: Thompson Station, Tennessee

Oncology is one of the major areas of focus for Medelis, a specialty CRO that conducts Phase I through Phase III cancer research trials, but it also provides expertise in other therapeutic areas, including nephrology, neurology, medical devices, and dental research. Being a niche oncology CRO, Medelis offers sponsors the unique benefit of their deep operational expertise, offered by their highly skilled and proactive clinical trial management team. Led by their group of experienced clinical research oncologists, this CRO has been a pioneer in immunotherapy studies since 2008, running numerous CAR T-cell therapy studies, checkpoint inhibitor studies, and bispecific antibody treatment studies. Among their services are study design assistance, strategic site selection, providing access to the right patient populations, and up-to-date regulatory guidance per the FDA, European Medicines Agency, and other agencies.

Notable News: As a smaller specialized CRO, Medelis is able to take a personalized approach that prioritizes each sponsor’s unique needs. The company has been brought on to rescue multiple cancer clinical trials and successfully delivered improved timelines, data quality, and increased enrollment rates. Whether it’s a standard dose-escalation Phase I trial or a complex rescue of a Phase III study, Medelis Oncology CRO boasts 91% of their projects are completed on time and 96% remain within budget.

2. Theradex Oncology CRO

Founded: 1982

Headquarters: Princeton, New Jersey

Next on our list of top CROs for oncology in 2025 is Theradex, a global mid-sized CRO that was founded upon being awarded the Clinical Trials Monitoring Service contract in 1982 for the U.S. National Cancer Institute (NCI). Originally, the company began with providing central data management and monitoring services for early phase oncology trials sponsored by the NCI. In 2014, this role expanded to lend additional support to clinical trials conducted under the NCI Experimental Therapeutics Clinical Trials Network (ETCTN). Today, Theradex’s services have extended to pharmaceutical industry sponsored oncology trials across the U.S., Europe, Asia, and Australia. As a mid-size company, this CRO has been able to grow their global footprint significantly while still maintaining a tailored approach to study management for each industry sponsor they partner with. Overall, Medelis has amassed over 40 years of experience in conducting quality oncology trials spanning a diverse range of cancers, including but not limited to, lung, breast, colorectal, and hematologic malignancies.

Notable News: In November 2022, Theradex Oncology CRO was appointed by Shuttle Pharmaceuticals to prepare for its Phase II clinical trial of ropidoxuridine to treat glioblastoma, a brain tumor. Specifically, they collaborated with Shuttle and the U.S. FDA to prepare the Investigational New Drug (IND) application for this trial. As of October 2024, the ropidoxuridine clinical trial has completed its clinical trial site enrollment and has begun enrolling patients with aggressive, IDH wild-type, methylation negative glioblastomas.

3. TFS HealthScience CRO

Founding Year: 1996

Company HQ Location: Lund, Sweden

4. Allucent Oncology & Hematology CRO

Founded: 1988

Headquarters: North Carolina (U.S.); Berkshire (United Kingdom); Schiphol (The Netherlands)

Since 1988, several life science CROs have undergone mergers while serving the specialized needs of small and mid-sized biotechs, leading to the company’s rebranding as Allucent in 2022. Over the last 30 years, this mid-sized CRO has amassed significant expertise in regulatory trends, therapeutic experience, and operational expertise in the field of oncology. Although, they also offer services for other therapeutic areas such as infectious disease and vaccines, autoimmune and inflammation, cell and gene therapy, and rare diseases. Today, the company’s global footprint spans over 75 years across North America, Europe, and the Middle East, with oncology trials making up the majority of its portfolio of over 825 clinical trials. The Allucent Oncology & Hematology unit supports its sponsors through every phase of drug development, from preclinical planning and IND submissions to the design and execution of Phase I-III clinical trials, including marketing applications, and Phase IV and post-marketing initiatives.

Notable News: In May 2024, Allucent was recognized with two CRO leadership awards presented by Clinical Leader and Life Science Connect in the Expertise and Compatibility categories across Small Pharma and Overall (Big and Small Pharma combined), respectively. Earlier this July, Allucent was also selected by the Biomedical Advanced Research and Development Authority (BARDA) for its new Decentralized Clinical Operations for Healthcare and Research (D-COHRe) initiative. This agreement was created for the U.S. Department of Health and Human Services to improve the nation’s ability to respond to future public health emergencies.

5. Ergomed Oncology CRO

Founded: 1997

Headquarters: Surrey, United Kingdom

Since 1997, Ergomed has grown into a leading global mid-sized oncology CRO with a strong presence across North America, Europe, and the APAC region today. Their wide array of comprehensive services, including clinical development, trial management, and pharmacovigilance support, have been relied on by more than 300 sponsors across 100 countries worldwide. Ergomed does offer expertise in multiple therapeutic areas (e.g., rare disease, neurology, etc.), but 32% of Ergomed’s entire clinical trial portfolio falls within cancer research, particularly for early-phase oncology trials, encompassing over 470 cancer projects that have enrolled more than 32,000 patients. Sponsors can also take advantage of this CRO’s long-standing track record with successful cell and gene therapy clinical trials, collaborative trial management processes, and comprehensive support for recruitment, logistics, and medical initiatives tailored to each investigative site. Ergomed’s accomplishments and strong background in oncology trials place it among the top CROs for oncology in 2025.

Notable News: In October 2024, Ergomed announced its CRO partnership with CEL-SCI Corporation for the upcoming U.S. FDA confirmatory Registration Study of Multikine^® (Leukocyte Interleukin, Injection) in head and neck cancer. As their oncology CRO , Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of this study, building on their previous partnership for the Phase 3 trial of Multikine^®, the largest study ever conducted in head and neck cancer.

Conclusion

As we approach 2025, these five leading specialty oncology CROs demonstrate the evolving landscape of cancer research. Medelis, Theradex, TFS, Allucent, and Ergomed each offer industry sponsors a unique blend of expertise and successful track record to help advance cancer treatment options and improve patient outcomes worldwide. For pharmaceutical and biotech companies seeking to conduct successful oncology trials, these CROs represent some of the most experienced and capable partners in the industry to watch in 2025!

TFS: Your Trusted Oncology CRO Partner

TFS HealthScience Oncology and Hematology CRO is dedicated to providing comprehensive services to support your oncology clinical trials. With a proven track record of over 300 cancer-related clinical trials across all phases, we’re committed to delivering solutions that match your needs. Our global operations teams are fully experienced with navigating the complex landscape of cancer clinical research, offering rigorous operational oversight and adherence to global standards. Visit our oncology CRO website to learn more or connect with a TFS representative here!

Interested in more Oncology and Hematology CRO content from TFS? Visit our Intellect Hub here to access white papers, articles, case studies, and more!