Blog | Think Bold, Think Scientific, Think Veristat

Gain the latest insights and trends in clinical trials, patient recruitment, data analysis, adaptive design, regulatory submissions and approvals.

Sign Up Today

gene therapy

1 min read

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...

READ MORE

1 min read

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...

READ MORE

2 min read

Part One: Key Takeaways for Successful Development of Cell and Gene Therapies

Cell and gene therapy (C&GT) products are beginning to deliver on their long-hoped-for promise. CAR-T technology has proven to be a powerful new weapon in cancer treatment, and FDA approval of Luxturna in 2017 demonstrated the potential of gene therapies...

READ MORE