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Single Arm Trials: How to Make the Future Brighter

Randomized clinical trials (RCTs) are widely recognized as the gold standard for clinical and regulatory decision-making. Indeed, RCTs would be required in most cases, in particular when modest...

Meet the Expert: Steve Silverman

Meet the Expert: Steve Silverman

Expert Consultant, Regulatory Sciences Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a...

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Clinical Research Solutions

Navigating Expedited Regulatory Pathways in Europe: The Latest Insights and Advancements

Are you truly up to speed on the most effective strategies to expedite the approval process for your innovative product in Europe's evolving regulatory landscape? In the United States (US), the Food...

How to Give Quality Assurance the Respect It Deserves During a Post-Merger Integration

A typical post-merger integration (PMI) between two companies is challenging, time-consuming, stressful, and resource intensive. Even the companies most experienced with integration find these...

Meet the Expert: Janice Worley

Meet the Expert: Janice Worley

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Recognizing the Value of Outsourcing GxP Audits

Recognizing the Value of Outsourcing GxP Audits

In today's highly regulated pharmaceutical, biotechnology, and healthcare industries, maintaining compliance with GxP Practices, and other regulatory requirements is paramount. Failure to meet these...

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FDA’s Updated Software Guidance

The FDA has recently published a number of software related guidance documents, covering topics such as off-the-shelf software, cybersecurity, closed-loop-control, and predetermined change control...

Meet the Expert: Savannah Kay Anzaldua

Meet the Expert: Savannah Kay Anzaldua

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Two women collaborating together in a laboratory.

Challenges in Oncology Trials: How to Navigate the Evolving Regulatory Landscape

Setting the Scene: What Makes Oncology Clinical Trials Different? Ever increasing knowledge of the molecular basis of malignant disease has stimulated development of targeted agents. This often leads...

Meet the Expert: Naila Musharraf Ali

Meet the Expert: Naila Musharraf Ali

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Group of health care professionals working at a table around a laptop computer.

How to Avoid Blind-Spots in Your Early-Stage Drug Development Program

Navigating the landscape of vital drug development? Discover the five crucial areas that could make or break your success. Early-stage drug development encompasses the initial phases of researching,...

Meet the Expert: Pinky Sharma

Meet the Expert: Pinky Sharma

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Navigating FDA User Fee Updates for Fiscal Year 2023

As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...

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Medical Information

DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

Meet the Expert Kamila Rocha

Meet the Expert: Kamila Rocha

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

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Clinical Pharmacology Considerations for Peptide Drug Products, September 2023

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall...