Blog | Veristat, The Science-First CRO

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Reflections from ASCO 2025

Clinical Impact, Technology Innovation, and Emerging Advances in Cell and Vaccine-Based Oncology

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Project Optimus Explained: Why the FDA is Shifting Away from Maximum Tolerated Dose in Oncology

Historically, oncology drug development followed a straightforward principle: identify the highest dose patients could tolerate without unacceptable side effects, then use that dose in subsequent trials and clinical practice. This maximum tolerated dose...

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Top 3 Tips for Choosing the Right Oncology CRO

The decision to partner with a Clinical Research Organization (CRO) is never taken lightly—especially in oncology. With high complexity, accelerated timelines, and evolving regulatory expectations, the stakes in oncology drug development are uniquely...

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Bayesian Study Designs in Early-Phase Oncology Trials

The development of innovative oncology therapies has evolved dramatically, moving beyond traditional chemotherapies to include immunotherapies, targeted agents, radiotherapies, and cell and gene therapies. As these new modalities emerge, the limitations...

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Biostatisticians: Ensuring the validity, reliability, and interpretability of clinical trial data

Discussion with Erin Mathias, Sr. Director, Global Biostatistics

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Cancer Research Trends | Key ASCO 2024 Takeaways

Discussion with Gabriela Rosu, MD, Sr. Director, Global Medical Affairs

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Positioning a Sponsor’s First Trial for Success: A Comprehensive Planning Approach for Cancer Antibody

Clinical trials require meticulous planning and strategic guidance for success. In this case study, Veristat's expertise was instrumental in transforming a clinical-stage biotech company's maiden Phase I trial for an immuno-oncology antibody.

Initially...

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Successful Full-Service, Randomized Pancreatic Cancer Phase II Trial

Learn how Veristat’s multidisciplinary team was able to work with the sponsor to solve challenges across numerous areas of this full-service phase II cancer trial. Collaborative efforts led to the sponsor decided not to close the Phase II study upon the...

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Understanding FDA's Project Optimus

Project Optimus is an initiative from the FDA Oncology Center of Excellence led by Drs. Mirat Shah and Atik Rahman.The goal of the initiative is to educate, innovate, and collaborate with the oncology community- including companies, academia,...

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Planning the Way Forward for a New Tumor Evaluation Modality

RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site...