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Home > library Library

Veristat Resource Library

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Therapeutic Area

Blog

Planning Your IND: When and Why to Engage the FDA

Many sponsors underestimate how much support the Food and Drug Administration (FDA) can offer ...

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Blog

Project Optimus Explained: Why the FDA is Shifting Away from Maximum ...

Historically, oncology drug development followed a straightforward principle: identify the highest ...

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Webinar Video Replay

Accelerating Patient-Centric Clinical Trials Through Science-Based ...

Watch the webinar with SubjectWell to get acceleration strategies

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Blog

Reflections from ASCO 2025

Gabriela Rosu, M.D., Vice President, Global Medical Affairs and Pharmacovigilance at Veristat, ...

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Blog

Monthly FDA Guidance and Regulatory News Review - May 2025

Stay updated with Veristat's May 2025 FDA guidance and regulatory news, including new drug ...

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Blog

Staying Ahead of Regulatory Change: CMC Strategies for Cell and Gene ...

The regulatory landscape for cell and gene therapies (CGTs) is shifting fast.

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Case Study

Optimizing EDC

Partner with Veristat to future-proof your early-phase rare disease trial with expert data ...

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Blog

Marketing Application Publishing Best Practices

While the publishing journey can vary depending on your therapy’s requirements, Veristat’s ...

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Blog

Multi-Regional Clinical Trials: Key Recommendations for a Global ...

The FDA recently released a draft guidance on the use of multi-regional clinical trials (MRCTs) in ...

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