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Case Study

Achieving an Aggressive NDA Timeline

Imagine you are completing your regulatory submission project with only nine months left until submission day and you still have to migrate legacy data into SDTM ...

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Case Study

Data Collection Efficiency for a Novel Anti-Infective Therapy

Learn how we improved data collection efficiency through thoughtful database design that allowed the sponsor to overcome a complex trial challenge and transition ...

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Case Study

Exceeding Expectations For Patient Enrollment Case Study

When Veristat partnered with a US based biotechnology company on a Phase II study for a topical spray to treat hypertension, our emphasis on effective planning and ...

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Case Study

Guiding an Oncology Program to Success

A clinical stage biotech firm engaged Veristat to run their very first ever clinical trial, a phase I US only oncology trial. When the project started, the client was ...

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Case Study

Keeping Up with an Over-Performing Site

Find out how Veristat was able to expertly rescue the site management and monitoring activities for a  sponsor seven months into patient enrollment at the ...

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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 rare oncology program from IND to NDA.

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Case Study

Overcoming an NDA Refusal To File

Learn how the right biostatistical experts performed a quality review of the clinical data for an NDA that received a Refusal-to-File from the FDA

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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 how we successfully helped a sponsor finalize their IND in under 6 ...

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Case Study

Preparing Data for a Marketing Authorization Application (MAA)

Read the case study to learn how we helped a biotech prepare the MAA submission for a recently acquired product. Our creative approach included utilizing one DB for ...