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Case Study

Approvals for an Ultra-Rare Hematologic Malignancy

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

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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 ...

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Case Study

Writing Multiple Marketing Applications At The Same Time

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

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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 ...

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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 ...

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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 ...

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Case Study

Site Monitoring Success With Teamwork

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

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Case Study

Preparing a New Drug Application (IND)

Veristat has collaborated with biopharmaceutical firms on the preparation of over 50 INDs. Learn ...

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Case Study

Medical Writing Partnership - IND to NDA

Learn how the Veristat medical writing team partnered with a sponsor and supported their entire ...

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