Clinical Research Solutions
FDA Drug Labeling Requirements & Regulations: What’s in Your Label?
Why Does Pharmaceutical Product Labeling Matter? Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters? A drug’s label...
Clinical Research Solutions
Common Challenges in Signal Detection in Pharmacovigilance and How to Overcome Them
In pharmacovigilance, recognizing and responding to safety signals quickly can be crucial for patient safety. A "signal" in pharmacovigilance refers to a hypothesis, supported by evidence, of a new...
Clinical Research Solutions
Digital Transformation in Life Sciences: The Importance of Data Strategy
What is Digital Transformation? While there are many different definitions of digital transformation in life sciences, the core concepts they all have in common are digital technology and creating...
Clinical Research Solutions
FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements
Implementing the eSTAR Format The eSTAR template is a positive step for both CDRH and medical device Sponsors; but, as with any new tool, there are challenges to utilizing the template. Sponsors need...
Clinical Research Solutions
Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
Digital Transformation
Meet the Expert: Dana E. Vanderwall, PhD.
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...
Clinical Research Solutions
Regulatory Chemistry, Manufacturing, and Controls (CMC): What to Expect During Drug Development
The key to successful drug development in the US is directional and focused navigation of FDA’s Investigational New Drug (IND) process. The Chemistry, Manufacturing, and Controls (CMC) section is a...
FSP Solutions
What is the FSP Model in Clinical Research?
The term Functional Service Provider (FSP) concept is highly regarded in the field of clinical research. With drug discovery and clinical trials becoming more complex, pharmaceutical firms and...
Clinical Research Solutions
Meet the Expert: Tariq Khan
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...
Clinical Research Solutions
FDA Animal Rule: Overview & Impact on Drug Development
What is the Animal Rule? The Animal Rule, a regulation set by the US Food and Drug Administration (FDA), applies to the development and testing of drugs and biological products intended to reduce or...
Clinical Research Solutions
Meet the Expert: Terri Levine
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...
Clinical Research Solutions
The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 2
Change in the Submission of the Summary Notification Information Format The Summary Notification Information Format Form As of January 31, 2023, Sponsors are required to submit a Clinical Trial...
Clinical Research Solutions
The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 1
The Benefit of the Common Application Form for GMO Applications GMO Application Not Included in Clinical Trial Regulation With the transition period for the Clinical Trial Regulation No 536/2014...
Clinical Research Solutions
Meet the Expert: Susanna Heinonen
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...
Clinical Research Solutions
Highlights from FDA's Analytical Test Method Validation Guidance
Recently, the FDA updated a long-standing, decades old guidance on analytical test method validation based on revisions of the ICH Q2(R2) guidelines. Traditional test method validation requirements...
Clinical Research Solutions
MLR Submission Content: Setting Yourself up for a Successful PRC Review
Having a highly efficient well-oiled Promotional Review Committee (PRC) machine is not just about having rock star reviewers and effective best practices in place. Although those are both critical...