Each year in January, the American Cancer Society releases its latest estimates of the number of cancer cases and deaths expected across the United States (U.S.). For 2025, nearly 2.2 million Americans are projected to be newly diagnosed with cancer, with an annual mortality rate of more than 618,000 deaths. Although cancer-related mortality has continued to decline through 2022, this year will undoubtedly present new opportunities and challenges in oncology research for clinical trial sponsors. Nationwide implementation of smoking reduction campaigns and improving detection methods for certain cancers, as well as the rapid pace of innovation within the therapeutic landscape in oncology, have helped avert 4.5 million deaths since 1991.  

To maintain this momentum in striving for a future without cancer, it is essential for oncology sponsors across the industry to carefully evaluate potential contract research organization (CRO) partners in order to find the most innovative CROs in cancer research. This article presents a comprehensive guide that explores the seven key factors to consider when choosing an oncology-focused CRO. Continue reading to discover how to select a cancer CRO that aligns with your clinical research goals and can maximize the chances of success for your next clinical trial. 

 

1. Specialized Expertise and Successful Track Record in Oncology Clinical Development

First and foremost, sponsors must assess a potential CRO partner’s depth of experience and expertise in oncology clinical trials. Many CROs are full-service organizations that offer a broad selection of therapeutic areas and disease indications, including a dedicated cancer research unit, whereas other CROs are specialized companies specifically with a niche focus on oncology clinical trials. Regardless of the CRO type, sponsors should look for organizations with a proven track record of managing complex oncology studies across various cancer types and phases of oncology clinical development.  

Sponsors can gain valuable insights into a potential CRO partner’s experience with different trial designs, including adaptive trials and basket studies, their understanding of appropriate endpoint selection for oncology trials, and familiarity with various therapeutic modalities, including small molecules, biologics, cell therapies, and combination approaches. Additional information can also be gleaned by examining the organization’s publication history and track record of successful regulatory submissions for cancer drugs. Finally, cancer research sponsors must assess how well the CRO’s expertise in oncology clinical trials aligns with their own study priorities and objectives. 

 

2. Robust Technological Infrastructure and Data Management Capabilities 

In 2025, it is more important than ever for sponsors to consider whether a potential CRO partner has strong technological and data management capabilities for successful trial execution. Ideally, the right oncology CRO should offer state-of-the-art electronic data capture (EDC) systems and advanced analytics platforms that support real-time data monitoring and analytics to promote more efficient decision-making from clinical and research stakeholders. Advanced CROs that are up to date with the latest industry innovations in technology may have already implemented AI and machine learning applications for patient recruitment and monitoring.  

Remote data management capabilities are also becoming essential to increase the geographic accessibility of cancer clinical trials to underserved communities all across the U.S. This includes experience with electronic patient-reported outcomes (ePRO) and remote monitoring digital tools that can integrate various data sources, including genomic and biomarker data. Sponsors must also consider a potential CRO partner’s approach to data security and compliance with international regulations, as well as review whether their service offerings encompass risk-based quality management, decentralized trial technologies, or hybrid trial models. Learn more about the future of clinical trials design in oncology in this published article.  

 

3. Oncology CRO with Global Reach and Quality Site Relationships 

The success of an oncology clinical trial comes down to the willingness of patients to participate, but this is a notorious roadblock in most therapeutic areas, but especially so in cancer research. In this 2021 US-based study, the estimated participation rate to cancer treatment trials was 6.3% nationally, which is higher than historical estimates of <5% but still remains disappointingly low. To alleviate the daunting recruitment challenges that sponsors typically face in most oncology trials, there are a number of strategies that can be implemented.  

First, evaluate the CRO’s global presence and their relationships with key opinion leaders in cancer research, as this may point to successful collaborations in the past with leading oncology centers and academic institutions. Second, consider their experience in managing multi-regional clinical trials; the right oncology CRO will have established processes for effective site selection and/or access to a network of oncology-focused research centers. Additionally, CROs with a strong global reach will be extensively familiar with regional differences in standard of care and regulatory requirements. Finally, review their track record in patient recruitment and retention specifically for past cancer clinical trials, including whether the organization has previously partnered with local patient advocacy groups.  

 

4. Commitment to Strategic Innovations for Patient-Focused Oncology Trials

Another key approach to minimizing the recruitment issues which commonly plague oncology study involves setting out to create patient-centric cancer clinical trials from the beginning. Modern CROs are increasingly committed to prioritizing patient experience and incorporating innovative approaches to improve trial participation and retention. Ideally, the right organization will demonstrate a strong commitment to patient-centricity in trial design and execution, reducing patient burden through innovative trial designs. Many already utilize remote monitoring technology, as mentioned earlier, to improve the patient experience, while implementing decentralized trial elements in oncology studies. Visit this page to learn how three new informatics-based technologies are transforming cancer care.  

Sponsors should also review whether their potential CRO partner has experience with patient support programs and engaging educational materials to ensure patients are fully informed throughout their trial participation. Other considerations include the CRO’s approach to diversity and inclusion in clinical trials, their willingness to incorporate patient feedback, and whether their patient retention strategies have demonstrated long-term success in oncology trials. Ultimately, the ideal CRO committed to conducting patient-centric cancer clinical trials will take a multi-pronged approach using these strategies and several others to reduce the burden of study participation in cancer patients. Learn more here about the pivotal role of patients in driving patient-centric cancer clinical trials.  

 

5. Quality Management and Regulatory Compliance in Cancer Clinical Trials

Other critical aspects of conducting cancer clinical trials worth considering when assessing a potential oncology CRO include their quality management systems and regulatory compliance processes. Sponsors can take steps to evaluate the CRO’s track record in previous regulatory inspections and audit outcomes because it demonstrates how robust their quality control processes are, while demonstrating their understanding of regional regulatory requirements. For example, January 31, 2025, marks the deadline for all ongoing clinical trials in the European Union (EU) to be transitioned to the Clinical Trials Information System (CTIS). Read more here about how the Clinical Trials Regulation (CTR) could affect sponsors in the EU this year.  

As mentioned earlier, past successes with oncology regulatory submissions are also evidence of the organization’s stringent regulatory compliance. Other inquiries for oncology sponsors to make when evaluating a potential CRO partner include probing their long-term risk management and mitigation strategies, examining how data integrity and compliance with Good Clinical Practice (GCP) guidelines are maintained, and their processes for managing protocol deviations and complex safety events.  

 

6. Oncology CRO with Operational Excellence and Efficient Project Management 

A defining characteristic of innovative CROs in cancer research is their ability to streamline clinical operations (ClinOps) with efficient project management teams. This is especially important for global oncology clinical trial management as more sponsors choose to invest their resources into running large-scale multi-regional cancer studies. It is crucial to review the organization’s project management methodology and communication protocols, particularly in cases of clinical trial timeline delays or if a serious issue suddenly arises.  

Ensuring operational excellence largely hinges on the success of the project management team, which would ideally consist of several professionals experienced in global oncology clinical trial management. Whether large or small, a strong project management team can present sponsors with robust contingency planning approaches, maintain reasonable budget management and cost control, and adapt seamlessly with protocol amendments and study changes. Sponsors can gain valuable insights into these capabilities by reviewing the CRO’s track record of successful milestone achievement in previous cancer trials. 

 

7. Financial Stability and Resource Allocation During Oncology Clinical Development

Finally, sponsors must account for the financial stability of a CRO and their ability to allocate resources effectively. This 2024 economic evaluation study of data from 2000 to 2018 reported the mean cost of developing a new drug was $172.7 million (2018 dollars). However, when both drug development failure and capital costs were included, this estimated cost increased to a staggering $879.3 million. These findings emphasize the large financial investment that clinical trials represent for sponsors and why partnering with the right oncology CRO can reduce these costs significantly.  

Approaches for evaluating the financial stability of a potential CRO can involve looking at their long-term sustainability strategies, reviewing their pricing models and cost transparency, and whether they are capable of maintaining consistent staffing throughout long-term trials. Efficient resource allocation is also crucial for complex oncology trials. This could involve implementing risk-based monitoring to ensure a larger focus is placed on the most high-risk clinical research sites or regions. Additionally, it is worth asking the CRO how they would manage change orders or budget modifications in the event of study changes or timeline delays. Previous successes with managing complex trial budgets are also strong indicators of the CRO’s financial expertise in oncology clinical trials. 

 

Conclusion 

As we have outlined in this comprehensive guide, selecting the right oncology CRO in 2025 requires careful consideration of multiple factors, from technical expertise to patient-centric approaches. By evaluating potential CRO partners across these seven key areas, sponsors can make informed decisions to maximize their chances of successful trial outcomes in their upcoming oncology programs. As we begin the new year, it is important to remember that the right oncology CRO should be ready to adapt to future challenges and innovations in oncology clinical research, in addition to meeting your current needs for a successful cancer clinical trial.  

 

TFS HealthScience: Your Global CRO Partner in Oncology & Hematology  

TFS HealthScience Oncology & 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 globally, 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!