Colorectal cancer CRO

Navigate scientific and regulatory complexities with a proven colorectal cancer CRO

As the second most common cause of cancer deaths1, colorectal cancer is a devastating diagnosis. But new treatments offer hope to patients and their families — and we want to help accelerate yours to market.

At Parexel, we’re a global colorectal cancer CRO that offers integrated services across every phase of clinical development. We bring innovative tools, trial designs, and expertise to your project, so you can find the patients you need, tackle trial complexities, navigate regulatory hurdles, and impact lives everywhere.

1Trends in the Incidence of Pancreatic Adenocarcinoma in All 50 United States Examined Through an Age-Period-Cohort Analysis
 

Experience in the past 5 years in colorectal cancer

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clinical projects
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patients
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sites

Advantages

Proven oncology expertise

Our dedicated oncology team has extensive expertise in gastrointestinal cancers. Our specialists also have wide experience as medical leads in different indications (adjuvant, radio chemotherapy, and metastatic settings) and with different investigational compounds. Their deep understanding of the evolving treatment landscape prepares them well to guide your study to success.

Advanced patient recruitment & retention
 

As your colorectal cancer CRO, we offer patient recruitment and retention strategies curated to your patients’ needs. Those include robust patient education, engagement across diverse populations, patient surveys, burden analyses, and more. We’re also guided by our Chief Patient Officer, Stacy Hurt, who’s a cancer survivor herself.

Global regulatory strategy and support

 

Our regulatory strategy team is 1,000+ strong, with proven experience navigating colorectal cancer studies around the world. We have three former CFDA/NMPA regulators and six ex-FDA regulators on our team. We’re ready to guide your colorectal cancer therapy every step of the way to approval and beyond.

Biomarker expertise
 

We’re experienced working with all types of biomarkers as an oncology CRO, such as genomics, transcriptomics, proteomics, and metabolomics. We also have deep expertise in biomarker strategy development for patient stratification and targeted therapy approaches. 

CASE STUDY

Meeting all milestones 5 months ahead of schedule for a Phase III study

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SituationSolutionOutcome

Situation

We conducted a full-service Phase III colorectal cancer study with over 1,500 patients in 14 countries across North America, Europe, and Asia Pacific. Challenges included:

  • Highly competitive clinical trial landscape that exhausted sites’ patient populations
  • COVID-19 restrictions in certain countries such as Israel, Singapore, Australia, Italy, and Spain
  • Regional differences in the standard of care and physician preferences
  • Tracking patient samples with large quantities of biopsies while coordinating with labs across the globe
     

Solution

  • Data-driven site selection, homing in on sites with the highest potential and top performers from previous experience
  • Site engagement, patient education, and dedicated individuals assisting with the implementation of customized and site-focused enrollment plans
  • Utilizing agreed-upon templates with sites for quicker start-up
  • Relationships with key opinion leaders, Site Alliance sites, and top-tier gastrointestinal oncology sites
  • Supporting enrollment by communicating with prospective patients and their caregivers to ensure study information is being presented accurately and effectively
  • Navigating COVID-19 restrictions by working in three batches for database lock across the sites
  • Tracking each sample from the point of collection with a sample registration portal in combination with the sample tracking database
     

Outcome

We met all milestones, including last patient in, five months ahead of schedule — exceeding patient recruitment expectations in the United States and South Korea.