Veristat Resource Library

Case Study

Supporting a Sponsor from SPA Rejection to BLA Submission

Successful Engagement with FDA to Achieve SPA Approval for Running the Phase III Pivotal Trial

Case Study

New Tumor Evaluation Modality

Using intratumor RECIST (itRECIST) criteria to measure effectiveness of cancer therapeutics

Case Study

Approvals for an Ultra-Rare Hematologic Malignancy

Regulatory Submission Strategy and Novel Efficacy Endpoint for Treatment of an Ultra-Rare and ...

Case Study

First Gene Therapy Approved in Europe

Veristat was brought in to create and manage a full development program for a gene therapy for a ...

Case Study

Writing Multiple Marketing Applications At The Same Time

A mid-size pharmaceutical company and its development partner, a small biotechnology company ...

Case Study

Stem Cell Therapy for Stroke Patients

A client engaged the Veristat team in a Phase II study of intracerebral stem cell injection in ...

Case Study

Complex Trial for a Rare Pediatric Gene Therapy

A clinical-stage biotechnology start-up asked Veristat to run a new European trial of their complex ...

Case Study

Full Service Support for A Gene Therapy Trial

A clinical-stage biotechnology start-up asked Veristat to run complex US and EU trials of their ...

Case Study

Site Monitoring Success With Teamwork

Imagine you are getting ready to launch the third drug cohort of your early phase clinical trial ...