To build a state-of-the-art oncology site network, we went back to basics

Major academic research centers in the United States are awash in cancer clinical trials and can afford to be choosy about which they participate in. At Parexel, we needed to differentiate our approach to be viewed as a preferred research partner. So, we analyzed how we could lower the burdens on sites and help them enroll and retain patients.

Myriad high-tech solutions, including artificial intelligence, remote source document verification, sleek digital technologies, and decentralization, promise to make clinical trials more efficient for sites. However, after analyzing the issues with some help from the Tufts Center for the Study of Drug Development, we concluded that technology is not the answer.¹  

We found that what sites want most from their partners are respect, relationships, and responsiveness. By organizing our processes around these values, we accelerated study start-up times by 37% and saw a 50% uptake in oncology and hematology trials from 2021 to 2024. Here are the three pillars of our approach:

1.    Respect for sites’ time

One recent study found that academic medical centers spend an average of 4,500 hours a year on feasibility assessments and qualification visits for clinical trials.²  We knew we needed to find a way to avoid making unnecessary and duplicative requests of overtaxed sites during the feasibility and qualification processes and beyond. 

For each site in our network, we created a comprehensive profile of its interests, geographies, capabilities, patient populations, and principal investigators (PIs). Our profiles include details such as a site’s pharmacokinetics and pharmacodynamics capabilities, the standard of care used to treat specific cancers and tumors, and the research priorities of its oncology PIs by tumor type and treatment modality. 

When a site joins our Site Alliance Oncology Network, we have already documented its skill sets, expertise, support, and infrastructure. So, to make feasibility and qualification assessments, we consult our internal database, which we update via regular check-in calls. 

Site selection is a strategic exercise, and our network includes a mix of sites, from prominent academic medical centers to regional hospitals to community-based clinics. We don’t overutilize specific sites to prevent burnout, and our profiling data helps us understand sites’ strengths and weaknesses. For example, many sponsors have recently sought our help to conduct clinical trials in acute myeloid leukemia (AML). Repeatedly referring our clients to the same sites would slow everyone's enrollment, so we maintain a deep enough bench of sites that studies don’t compete for the same patients. 

Another way we respect sites is by screening sponsors’ protocols for the burdens of new technology. For sites, multiple passwords and cumbersome user interfaces lead to time spent managing systems rather than patients. 

Before imposing a new technology or data collection device on a site, we test it to ensure that it is not a solution in search of a problem. For example, we recently piloted a new way to automate the distribution and receipt of clinical medications at a handful of sites before implementing it broadly. Site staff used the technology and offered suggestions to ensure it would be feasible and effective for clinical trials.

2.    Relationships for mutual benefit

Clinical trials are complex, with many moving parts, and there are always problems to resolve: Is enrollment on track? Why wasn’t this invoice paid? However, site study managers often don’t know whether to bring their issues and questions to the trial sponsor or the clinical research organization (CRO).
At Parexel, we assign each site in our network a single point of contact: the site alliance manager (SAM). SAMs operate at the site level, not the study level. Likewise, each site nominates a single point of contact to identify efficiencies and drive trial start-up and recruitment. Thus, everyone knows whom to ask when they have questions.

Relationships are critical to sites. Surveys show that sites are frustrated by sponsors and CROs that approach them with a “one-size-fits-all” mentality without knowing their specific capabilities, needs, and experience.³  We treat the site-CRO relationship as a long-term strategic partnership, which helps key site and CRO staff communicate with greater trust and accountability.

These simple changes in our process and mindset allow us to activate trials faster. For example, a large pharmaceutical company recently asked us to activate a Phase 1 first-in-human trial at one of our network sites in less than three months while warning us there would be a major protocol amendment during the process. The average time from the qualification visit (QV) to the study initiation visit (SIV) is closer to four months. Because we had a long-established relationship with the Tier 1 oncology site and its knowledge opinion leaders (KOLs), our team could discuss the tight deadlines with them and make realistic adaptations. Our internal site profiling data told us the sponsor could pre-approve all study-related fees (including expedited fees) before we negotiated the clinical trial agreement (CTA) and budget. We launched the trial in 87 days, beating the deadline. 

3.    Responsiveness to sites’ needs

Once you have a network of sites, you must maintain it by engaging and communicating with them. This requires clinical expertise and commitment. The culture of oncology and hematology clinical research is distinct, and often, PIs, KOLs, and experienced study managers don’t have the time or interest to explain its nuances to newcomers.  All our clinical trial professionals have an oncology or hematology background and are passionate about the field. Many have lost loved ones to cancer or are cancer survivors. 

At Parexel, we monitor our responsiveness with sites by tracking key performance indicators, such as how quickly we reply to emails, feasibility submissions, and last-minute questions. We also keep data on contract cycle timelines and other key metrics.  A patient’s eligibility for a trial may depend on site staff describing and documenting as many as five prior treatment regimens. If they have a question, they need an immediate response. Parexel is available to sites 24 hours a day, seven days a week, in every time zone worldwide. 

A site-centric approach works

Deaths from cancer in the United States dropped by 34% from 1991 to 2022, in part due to treatments and regimens first tested in clinical trials.⁴ Targeted therapies and immunotherapies have rewritten 5-year survival rates: 22% to 70% for chronic myeloid leukemia, 18% to 35% for melanoma, and 26% to 43% (3-year survival rates) for non-small cell lung cancer.⁵  

Clinical research saves lives, but the increasing volume and complexity of cancer trials can burden investigative sites. Our site-centric approach improves R&D efficiency and helps deliver effective new treatments to the patients who need them.

Resources

1. Back to (Communication) Basics: Reducing Site Burden and Establishing a Sponsor/CRO-of-Choice Relationship with Investigative Sites, DIA Global Forum (June 2024).
2. Benchmarking the Investigative Site Qualification Process, Applied Clinical Trials (February 10, 2025).
3. Back to (Communication) Basics: Reducing Site Burden and Establishing a Sponsor/CRO-of-Choice Relationship with Investigative Sites, DIA Global Forum (June 2024).
4. Cancer Statistics, 2025, CA: A Cancer Journal for Clinicians, (January 16, 2025).
5. Ibid.

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