Clinical Research Solutions
Rescuing a Struggling PV Program: Warning Signs, Root Causes, and What to Do Next
Living near the ocean growing up, I have been warned countless times that by the time you realize you are in a riptide, you may already need to be rescued. You'll know things aren't going quite...
Clinical Research Solutions
Selecting a PMPV Vendor, Part II: Building on a Strong Foundation
Previously, we outlined the critical components to be considered when starting a clinical trial program (Safety Services: A Critical Component of Clinical Trials). In this second installment we'll be...
Clinical Research Solutions
Vigilance by Another Name
Do regulations and guidance documents sometimes stagnate your learning progress because of the terminology used? Regulation confusion is a common complaint heard from current and prospective new...
Clinical Research Solutions
EU Clinical Trials Regulation: Time Is Running Out, Are You Ready?
On January 31, 2022, the EU Clinical Trials Regulation 536/2014 (CTR) came into force with a transition period of three years. Now, as that transition period comes to a close, the process and need...
Pharmacovigilance
How to Spring Clean Your PV Safety Data for Optimal Performance
As the blossoms of spring usher in a season of renewal, it's not just our homes that could use a thorough cleaning – our safety data deserves a refreshing sweep too. In an enlightening conversation...