2 min read
Biostatisticians: Ensuring the validity, reliability, and interpretability of clinical trial data
Discussion with Erin Mathias, Sr. Director, Global Biostatistics
Home >
Blog
Blog | Veristat, The Science-First CRO
Gain the latest insights and trends in clinical trials, patient recruitment, data analysis, adaptive design, regulatory submissions and approvals.
Sign Up Today
Oncology
2 min read
Cancer Research Trends | Key ASCO 2024 Takeaways
August 28, 2024
Discussion with Gabriela Rosu, MD, Sr. Director, Global Medical Affairs
1 min read
Positioning a Sponsor’s First Trial for Success: A Comprehensive Planning Approach for Cancer Antibody
November 1, 2023
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...
1 min read
Successful Full-Service, Randomized Pancreatic Cancer Phase II Trial
June 22, 2023
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...
1 min read
Understanding FDA's Project Optimus
May 16, 2023
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,...
1 min read
Planning the Way Forward for a New Tumor Evaluation Modality
August 31, 2022
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...
1 min read
Is it Possible to Gain Regulatory Approval Following a Single-Arm Study?
April 26, 2022
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...