Oncology & Hematology
Turn complex oncology data into clearer development decisions and submission-ready evidence.
For patients with cancer, delays caused by the wrong endpoint, an overly complex protocol, slow recruitment, or data that cannot inform the next decision can mean waiting longer for a potentially meaningful treatment.
Oncology sponsors need evidence that can guide development while standards of care, patient populations, and regulatory expectations continue to evolve. In the past five years, Veristat teams have supported more than 480 oncology and hematology studies, prepared more than 70 INDs/CTAs, and supported more than 30 US and European regulatory marketing applications.
Our expertise encompasses traditional cancer treatments, devices and diagnostics, and specialized therapies, including vaccines, gene and cell therapies, and immunotherapies.
Oncology and hematology trials leave little room for disconnected decisions.
Study design affects feasibility, operational choices shape data quality, and the evidence must ultimately hold up in a regulatory submission. Veristat connects clinical, biometrics, medical writing, and regulatory expertise so data becomes direction earlier, risks are addressed before they compound, and sponsors can move toward approval with greater confidence.
Veristat provided strong data, very high-quality stats work, as well as fair, balanced, and compelling medical writing telling the story behind the data. Your team contributed essentially to all areas. Our sincere thanks for the partnership that made the preparation of our now approved NDA possible.
Oncology Expertise for Decisions That Cannot Wait
Our depth spans the full range of cancer and blood disorder complexity, not just the most common indications.
Solid Tumors
From protocol design through regulatory submission, we bring the clinical operations, biostatistics, and regulatory expertise needed to navigate complex endpoints, evolving standards of care, and demanding patient populations across solid tumor indications.
Rare Cancers
Small, hard-to-reach patient populations require a different playbook. Our team combines patient recruitment strategy, adaptive trial design, and regulatory consulting to help you build evidence even when traditional trial designs fall short.
Blood Diseases
Hematologic malignancies and blood disorders demand close safety oversight and specialized data management. Our medical monitoring, data monitoring committee support, and biometrics teams work together to keep your trial safe, on track, and submission-ready.
CASE STUDY
Successful Full Service, Randomized Pancreatic Cancer Phase II Trial
A clinical-stage biopharmaceutical company approached Veristat for a multi-center, randomized Phase II study of a modified synthetic peptide in patients with exocrine pancreatic cancer. The study aimed to establish the efficacy and safety of combination therapies in patients with stage IV exocrine pancreatic cancer. Learn how Veristat's multidisciplinary team worked with the sponsor to solve challenges, including slow recruitment, data cleansing post-MSU, and site staffing.
Read the Case Study →
By partnering with a like-minded, scientifically focused company such as Veristat, we have found a core team of high-caliber collaborators who can help us accelerate the development of our new class of targeted cancer therapies.
— Chief Medical Officer, Mid-Size Biotech
PROOF POINTS
Veristat's Proven Impact: Oncology/Hematology Experience in the Past 5 Years
480+
Clinical Trials & Consulting Projects
30+
Marketing Applications (NDAs, BLAs, MAAs) Prepared
90%
of global operations team members have oncology/hematology experience
PROOF & RESOURCES
Real Programs, Real Outcomes
Why You Need a CRO That Excels in Oncology Regulatory...
Download →
ASH 2025: Interpreting Rapid Change Across Hematology
Read more →
A Practical Guide for Managing Multiple Global Regulatory...
Download →
What decision does your oncology program need to support next?
Whether the pressure sits in study design, enrollment, data interpretation, trial delivery, or submission readiness, start with the problem in front of you. We will help you connect it to the evidence and decisions ahead.
Frequently Asked Questions
Veristat's oncology team has experience across a range of solid tumor indications, including brain, breast, gastrointestinal, lung, and skin cancers, alongside rare cancers and hematologic malignancies.
