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Clinical Trial Regulations

2 min read

Demystifying eCTD 4.0: What You Need to Know

Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies' interactions with global health authorities. Over the past two decades, eCTDs have evolved from a basic electronic substitute for paper to a robust, standardized...

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2 min read

Mastering a Global Approach to Medical Writing

Medical writing plays an essential role in clinical development and regulatory approval. As scientific advancements grow more complex, well-structured documentation ensures the success of clinical trials, facilitates regulatory review, and accelerates...

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3 min read

Planning Your IND: When and Why to Engage the FDA

Many sponsors underestimate how much support the Food and Drug Administration (FDA) can offer during early drug development, often believing they need more data than is truly required before engaging. But once your proof-of-concept data, clinical...

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3 min read

Project Optimus Explained: Why the FDA is Shifting Away from Maximum Tolerated Dose in Oncology

Historically, oncology drug development followed a straightforward principle: identify the highest dose patients could tolerate without unacceptable side effects, then use that dose in subsequent trials and clinical practice. This maximum tolerated dose...

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3 min read

Monthly FDA Guidance and Regulatory News Review - May 2025

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...

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2 min read

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

The regulatory landscape for cell and gene therapies (CGTs) is shifting fast. From increased scrutiny on Chemistry, Manufacturing, and Controls (CMC) to operational challenges at the U.S. Food and Drug Administration (FDA), sponsors must be prepared to...

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5 min read

Multi-Regional Clinical Trials: Key Recommendations for a Global Clinical Development Program

The FDA recently released a draft guidance on the use of multi-regional clinical trials (MRCTs) in oncology research. A well-planned MRCT can be an efficient approach to the global clinical development of a novel product, allowing for access to a wider...

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3 min read

Top 3 Tips for Choosing the Right Oncology CRO

The decision to partner with a Clinical Research Organization (CRO) is never taken lightly—especially in oncology. With high complexity, accelerated timelines, and evolving regulatory expectations, the stakes in oncology drug development are uniquely...

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3 min read

Ensuring Patient Safety and Data Integrity with Veristat’s DMC Expertise

Data Monitoring Committees (DMCs) play a vital role in clinical trials by providing independent oversight to ensure patient safety, maintain scientific validity, and uphold data integrity. With clinical trials becoming increasingly complex, especially...

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3 min read

Bayesian Study Designs in Early-Phase Oncology Trials

The development of innovative oncology therapies has evolved dramatically, moving beyond traditional chemotherapies to include immunotherapies, targeted agents, radiotherapies, and cell and gene therapies. As these new modalities emerge, the limitations...

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