A Scientific Approach to Advance Your Novel Cancer Therapies

Oncology studies are complex, but a partnership with your CRO shouldn’t be. Our scientific-minded experts have successfully supported over 750 oncology projects and marketing applications in the United States, Europe, and Japan. Veristat’s deep experience spans the clinical development life-cycle - and is offered as a comprehensive, all-inclusive solution or as functional support. This month, we’re featuring some of the ways our teams have helped sponsors accelerate positive outcomes, resulting in less work for sponsors and more hope for patients.

Case Study: Successful Full-Service, Randomized Pancreatic Cancer Phase II Trial  

A biopharma company approached Veristat in a multi-center Phase II study for patients with exocrine pancreatic cancer. The sponsor engaged our team for biostatistics and programming, data management, monitoring and site management, medical safety, quality assurance, and medical writing, leading to continued collaboration in the Phase III study. Learn more >

Case Study: Approvals for an Ultra-Rare Hematologic Malignancy

A small biotech company engaged Veristat early in clinical development for help with a novel biologic being tested for treatment of an ultra-rare and aggressive hematologic malignancy with no available effective therapies. Using the results of a single-arm Phase I/II study, Veristat and the sponsor company collaborated to present a thorough, well-planned strategy for demonstrating the benefits and risks of the targeted therapy in this patient population to regulatory authorities. Read more >

Blog: 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 to advance a dose-finding and dose-selection paradigm that emphasizes the selection of an optimal dose (or doses) in the pre-market setting. Read more >

Infographic: Guidelines for Response Criteria for Use in Oncology Trials

After its introduction in 2000, RECIST (Response Evaluation Criteria in Solid Tumors) has evolved to meet industry needs as novel therapies come into development. Take a look at this infographic for guidelines on how RECIST is used in oncology trials including when and why to implement iRECIST and itRECIST. Get the guidelines >

Upcoming Events/Webinars

Event: DIA Global Annual Meeting 2023 - June 25 | Boston, MA

Webinar: Impact of New MDR on the Development of Drug-Device Combination Products - June 29 | 4-5 PM CET | 3-4 PM BST

Updated Webinar: Future Trends on European Regulations on Medicines - July 11 | 4-5 PM CET | 3-4 PM BST

Event: Bio Asia 2023 - July 26 |  Taipei, Taiwan