Liver cancer CRO

Accelerate your treatment to market with an experienced liver cancer CRO

Since the 1980s, liver cancer rates have tripled in the U.S., and it’s one of the most common cancers in many sub-Saharan and Southeast Asian countries.1 Patients around the world deserve new liver cancer therapies. We want to help get yours to market.

As an experienced liver cancer CRO, we offer integrated services across every phase of clinical development. Our therapeutic approaches include immunotherapy trials, targeted therapies, novel combination therapies, biomarker-driven trials, studies addressing different anatomical subtypes, and adaptive rare disease trials. For hepatocellular carcinoma (HCC) studies in particular, we often design trials involving:

  • Systemic therapies
  • Locoregional treatments
  • Combination approaches
  • Biomarker development
  • Studies in specific populations


1Study Highlights Increasing Global Health Burden of Liver Cancer


 

Experience in the past 5 years in colorectal cancer

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clinical projects
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patients
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Advantages

Proven oncology expertise

Our dedicated oncology team has extensive expertise in gastrointestinal cancers. We know how to address the complexities of liver cancer trials, such as stratification challenges and the designing of adaptive or biomarker-driven trials. Our understanding of rapidly evolving standards of care, including immune checkpoint inhibitors, also equips us well to guide your study to success.

Advanced patient recruitment & retention
 

As your liver cancer CRO, we offer patient recruitment and retention strategies to help you meet the needs of your trial. We leverage site alliance relationships to access limited patient populations and navigate strict enrollment criteria, and we use robust patient education, surveys, and burden analyses to help keep participants engaged.

Global regulatory strategy and support

 

Our regulatory strategy team is 1,000+ strong, with proven experience navigating liver cancer studies around the world. We have three former CFDA/NMPA regulators and six ex-FDA regulators on our team. We also have experience with many global authorities, including FDA, EMA, MCC, MHRA, PMDA, BfArM, NMPA, and PEI. We’re ready to guide your liver cancer therapy to approval as your oncology CRO.

Biomarker expertise
 

We have expertise working with all types of biomarkers, such as genomics, transcriptomics, proteomics, and metabolomics. We also have extensive experience in biomarker strategy development for patient stratification and targeted therapy approaches.

CASE STUDY

Best in class: Achieving success in advanced HCC

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SituationSolutionOutcome

Situation

We conducted a Phase III first-line therapy trial for advanced, unresectable HCC, spanning several countries — including France, Germany, Hong Kong, Italy, Japan, Republic of Korea, Singapore, Spain, United States, and Vietnam. We faced a variety of challenges:

  • Some patients weren’t able to produce fresh tumor tissue samples for histopathological confirmation of their HCC due to the progression of their condition.
  • Child-Pugh class B (CP B) patients were more likely to have cirrhosis of their liver, making histopathological confirmation of the HCC not clinically feasible.
  • Patient inclusion baseline values for adequate organ and bone marrow function constrained the available patient pool.
  • There were region, body-type, and age-related differences in the patients’ natural creatinine clearance (CrCl) levels.
  • Older patients were uncomfortable with downloading the eCOA reporting app onto their personal cellphones.

Solution

  • Additional flexibility in HCC diagnosis relieved the burden for some patients by allowing archival tumor tissue samples to be used for confirming the HCC diagnosis.
  • Allowing patients with cirrhosis to confirm their HCC through radiological findings increased the available patient population and boosted recruitment.
  • Participant enrollment was facilitated, especially in CP B patients, by expanding the inclusion ranges for hemoglobin, platelets, and TBL values without active or chronic bleeding.
  • Increased flexibility in the CrCl inclusion requirements accommodated for variability in the patient population by allowing them to be assessed per institutional guidance rather than be restricted by a set threshold value.
  • Participants were given several options for completing their eCOAs in the case that some patients were uncomfortable with some of the methods, improving patient compliance and complete data collection.

Outcome

The study was a success, with a Last Patient In reached 10 days early.