Clinical Pharmacology Gap Analysis: Lessons Learned Blog Post

Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for…

What’s New in Enterprise 3.4 Q&A Blog Post

Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded to Enterprise? In your demo, I noticed populated fields for the Core column differs from...

Achieving Compliance with the FDA’s eCTD Mandate Blog Post

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs…

Using M&S to Evaluate Oncology Drug Dosing Blog Post

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be…

The Many Challenges of Narrative Writing Blog Post

Narratives are an essential part of any programs’ story, but often become cumbersome due to the many challenges of narrative writing. A large narrative project is typically divided into several…