Veristat Case Studies
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A Successful Full-Service, Randomized Pancreatic Cancer Phase II Trial
5/18/2023
Learn how a clinical-stage biopharmaceutical company was able to reach a unanimous decision after a safety review committee data review meeting to close Phase II and advance to Phase III.
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Expert IND Publishing Support For An Understaffed Regulatory Team
5/10/2023
Discover how a clinical-stage biotechnology company was able to successfully file its IND submissions and complete CSR publishing tasks, in addition to creating a synchronized team.
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Expertise In RNA Therapies: Client Success Stories
2/17/2023
Learn how to navigate the complex challenges of accelerating therapies through clinical development to regulatory approval and commercialization.
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Supporting A Sponsor From SPA Rejection To BLA Submission
8/22/2022
Learn how the clinical trial design and the statistical foundation of the special protocol assessment (SPA), which helped drive to regulatory agreement, was transformed in this case study.
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New Tumor Evaluation Modality To Measure Effectiveness Of Cancer Therapies
5/31/2022
In this case study, delve into how the team used intratumor RECIST (itRECIST) criteria as the solution to measuring the effectiveness of a novel cancer therapeutic.
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Gaining Regulatory Approval Following A Single-Arm Phase I/II Study
3/23/2022
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. Discover what happens in this case study.
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Writing Multiple Marketing Applications Simultaneously With Accelerated Timelines
4/28/2021
A mid-size pharmaceutical company and its development partner, a small biotechnology company engaged us to complete the medical writing for their product’s Marketing Authorization Application (MAA), New Drug Application (NDA), and New Drug Submission (NDS). Learn how our medical writing team worked closely with the sponsors to write these marketing applications in an accelerated timeline.
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Preparing Data For The Marketing Authorization Application (MAA) Of A Recently Acquired Product
4/28/2021
A mid-sized biopharmaceutical company dedicated to developing innovative therapies for patients with debilitating rare diseases acquired the rights to a new investigational drug from a large pharmaceutical company with the intention of preparing the data for a Marketing Authorization Application (MAA). Learn how our team had to think creatively to enter, clean and standardize the clinical trial data from previous and ongoing trials in order to get the MAA ready for submission in an extremely short timeline.
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Groundbreaking Work Leads To First Gene Therapy Ever Approved In Europe
1/14/2021
Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in completely uncharted waters – our team had to create industry best practices that didn’t exist before, anywhere. With no classic route to market, Veristat’s experts wrote the map on patient recruitment, regulatory and health agency engagement, natural history studies and the Central Site Model.
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Supporting Multiple Global Gene Therapy Studies For Rare Diseases
11/17/2020
See how these CGT experts were able to address many complicated challenges – including site start-up issues, stringent regulatory requirements, and the logistics of handling highly sensitive genetic material.