Blog | Veristat, The Science-First CRO

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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...

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Is it Possible to Gain Regulatory Approval Following a Single-Arm Study?

In this case study example - yes.

Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm...