Cancer clinical trials play an important role in detecting, treating, and curing this challenging disease.
Oncology studies are complex, but a partnership with your CRO shouldn’t be. Veristat has successfully supported over 700 oncology projects and marketing applications in the United States, Europe, and Japan. Our deep experience assures you that we’ll overcome even those unexpected hurdles with efficiency and success. 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: Approval for Rare Hematologic Malignancy
A novel biologic was 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 strategy for demonstrating the benefits and risks of the targeted therapy in this patient population to regulatory authorities. The sponsor engaged our team for strategic consulting, statistical and programmatic support, and medical writing to plan and execute the marketing application process, eventually leading to both FDA and EMA approval.
After its introduction in 2000, RECIST (Response Evaluation Criteria in Solid Tumors) has evolved to meet industry needs as novel therapies come into development. This piece walks through how RECIST is used in oncology trials including when and why to implement iRECIST and itRECIST.
Veristat was brought on to write a sponsor’s protocol for a novel therapy that injects treatment into solid tumors. The application of a set of nuanced response criteria required information collected from injected lesions and non-injected lesions to determine a tumor’s response to the treatment.
When the complexities of designing and executing cancer trials in a highly competitive and complicated market can mean delays in delivering urgently needed treatments to patients, it pays to have a trusted partner by your side. In the past five years, our experienced teams have helped clients with more than 300 oncology studies and have worked on more than 30 US and European regulatory marketing applications for cancer treatments, including many rare cancers.
