Veristat Resource Library
Case StudyExpert IND Publishing
Learn how expert IND publishing supported an Understaffed Regulatory team.
Case StudyExpertise in RNA Therapies
Learn how Veristat has supported some of our Biotech Sponsors in advancing their RNA therapeutics.
Case StudySupporting a Sponsor from SPA Rejection to BLA Submission
Successful Engagement with FDA to Achieve SPA Approval for Running the Phase III Pivotal Trial
Case StudyNew Tumor Evaluation Modality
Using intratumor RECIST (itRECIST) criteria to measure effectiveness of cancer therapeutics
Case StudyApprovals for an Ultra-Rare Hematologic Malignancy
Regulatory Submission Strategy and Novel Efficacy Endpoint for Treatment of an Ultra-Rare and ...
Case StudyFirst Gene Therapy Approved in Europe
Veristat was brought in to create and manage a full development program for a gene therapy for a ...
Case StudyWriting Multiple Marketing Applications At The Same Time
A mid-size pharmaceutical company and its development partner, a small biotechnology company ...
Case StudyUnderstanding and Operationalizing A Complex Adaptive Design
A clinical-stage biopharmaceutical company came to Veristat with a complex statistical methodology ...