Bladder cancer CRO

Accelerate your trial and improve patient outcomes with a proven bladder cancer CRO

At Parexel, we offer the oncology expertise, operational capabilities, and innovative approaches you need to navigate the unique challenges of bladder cancer therapy trials.

As an experienced bladder cancer CRO, we offer integrated services across every phase of clinical development. Our therapeutic approaches include immunotherapy trials, targeted therapies, combination therapies, and novel surgical and radiation techniques. We also have experience across a wide range of study types, including:

  • Interventional trials
  • Non-interventional/observational studies
  • Biomarker studies
  • Diagnostic studies
  • Registry studies
     

Experience in the past 5 years in bladder cancer

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clinical projects
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patients
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sites

Proven expertise in oncology

Our dedicated oncology team has specialists with extensive expertise in genitourinary cancers and medical and scientific consultants with backgrounds in urologic oncology. Their deep understanding of the evolving treatment landscape — from conventional bladder cancer therapies to novel approaches — prepare them well to guide your study to success.

Advanced patient recruitment & retention

As your bladder cancer CRO, we offer patient recruitment and retention strategies tailored to the unique needs of your patients. We know how to recruit an aging demographic that often has comorbidities and how to keep them engaged with programs that meet their needs, such as decentralized trials.

Global regulatory strategy and support

Our team of 1,000+ regulatory strategy experts has proven experience navigating bladder cancer studies around the world. Our strong relationships with authorities and patients alike guide us in selecting the right oncology endpoints for approval. We also have experience with breakthrough and accelerated approval pathways for novel therapies, companion diagnostic support for targeted therapy development, and post-approval study design experience for long-term safety monitoring.

Innovative study designs

To deliver an effective trial that’s tailored to the unique challenges of bladder cancer, we design your study with the latest innovations and capabilities. That includes adaptive trial designs to address the heterogeneous nature of bladder cancer, biomarker-driven strategies to identify the patient populations most likely to benefit from a targeted therapy, specialized imaging and diagnostics, and real-world evidence integration to complement traditional clinical endpoints.

Data-driven insights

Our advanced data and analytical capabilities as an oncology CRO provide the insights your trial needs. We use specialized statistical approaches to handle complex endpoint hierarchies, conduct time-to-event analyses for recurrence and progression endpoints, offer expertise in quality of life assessments, and more.

CASE STUDY

Optimizing a global urothelial cancer study

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SituationSolutionOutcome

Situation

We needed to run a global phase III study with 800 patients with advanced or metastatic urothelial cancer. Our sites spanned 25 countries in the EU, APAC, and NA regions, bringing multiple challenges:

  • The need to adjust the patient safety monitoring process to improve timelines for ethics committee approvals and site activation in several countries
  • Control arm SoC treatment concerns among investigators, as the study didn’t include options for chemotherapy follow-up maintenance treatments
  • Patient survival follow-up assessments for progression-free survival (PFS) and overall survival (OS) endpoints that lasted a maximum of 5 years after the last patient was enrolled
  • The patients’ immediate need for treatment, which prevented some from participating in screening activities
     

Solution

  • Improve patient safety monitoring by providing guidance for appropriate adverse reaction assessments and guidelines for IP dose modification — strengthening the protocol and facilitating ethics committee approval
  • Revise the protocol to allow patients to receive maintenance therapy (e.g., avelumab) following completion of the chemotherapy regimen 
  • Perform phone call visits to confirm patient survival and status, ensuring vital data was collected while minimizing patient burden and improving retention
  • Expedite enrollment by proactively communicating with investigators about what samples needed to be collected and alerting the central lab of incoming shipments so results could be obtained immediately and dosing started as soon as possible
     

Outcome

Our experience, expertise, and adaptability as a bladder cancer CRO empowered us to reach our Last Patient Entered milestone ahead of schedule.