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Choosing the Right SEND Managed Services for Your Organization

Choosing the right Standard for Exchange of Nonclinical Data (SEND) managed services for your organization is essential for compliance. Get the facts here.

Blog Streamlining Preclinical Studies with the Right SEND-Managed Services In the rapidly evolving field of preclinical research, the effective management and sharing of extensive nonclinical data have become a significant challenge for organizations. This challenge is effectively addressed by the Standard for Exchange of Nonclinical Data (SEND), an essential framework in this context. SEND serves […]

IND Submission: The Key Step in the FDA Approval Process

Blog IND Submission and Its Role in the FDA Drug Approval Process Did you know that only one out of every ten drugs that go into clinical trials passes testing and gets approval from the government? This statistic is a clear reminder of how difficult it is to bring a new drug to market. It demonstrates how […]

The Top Challenges Facing Today’s SEND Submission

Blog The Biggest SEND Submission Challenges for 2023 In today’s data-driven world, industries across the board are embracing data standardization to ensure uniformity and maintain organization. This is particularly important for the United States Food and Drug Administration (FDA), as they regulate a wide range of products that people consume or use, such as medications, […]

Understanding SENDIG v3.1.1: A Comprehensive Guide

Blog Do You Wish You Knew More About SENDIG v3.1.1? Struggling to grasp the complexities of the Standard for Exchange of Nonclinical Data? Navigating this essential aspect of your business can be challenging. If you’re not well-versed in understanding SENDIG v3.1.1, errors could lead to costly consequences for your organization. Our all-encompassing guide simplifies SENDIG […]

Submitting NDAs: A Key Milestone in the Drug Development Journey

Blog Submitting NDAs: A Pivotal Milestone in the Drug Development Journey Developing a new drug can be lengthy and complex, often taking 12-15 years before receiving approval in the United States. A crucial component in this journey is submitting NDAs (New Drug Applications), which is both complex and challenging. The process demands considerable investment, expertise, […]