EMA SPOR Working group release the details to the SPOR Change Liaison Group
EMA SPOR Working group release the details to the SPOR ...
Enabling an Evidence-Based Approach to Pharmacovigilance and Safety
Safety departments at Marketing Authorization Holders & Regulatory Authorities are ...
CTMS Solutions: Finding the Right Clinical Trial Management System
Managing a clinical trial is no small feat. Documents must ...
Electronic Trial Master File (eTMF) Systems Tell Compelling Story of COVID-19 Vaccines
The rapid development of Covid-19 vaccines may lead more drug ...
Drug Adverse Event Reporting Software is Now Mobile-Friendly
Every one of us at some point will take a ...
Creating a Unified Clinical and Regulatory Data Management Strategy
Examining the challenges involved, benefits to be gained and requirements of unified regulatory and clinical business processes, as well as recommendations for taking the next steps forward.
Connected to the Future: Making Drug Safety Databases Transparent, E2B R3 Compliant and Cost-Effective
As different regulatory authorities have different timelines for adoption of these standards, E2B(R2) E2B(R3) will have to coexist. But having to operate two solutions creates huge complexities, unless you find a solution compliant with both. ArisGlobal LifeSphere Safety MultiVigilance is the only drug safety database solution provider thus far to provide full compliance to E2B R2 and E2B R3 standards for both import and export.
CRO (Contract Research Organization) Research & Development Trends
CRO industry grows as increasingly complex R&D trends demand advanced ...
Building an Open, Interconnected Regulatory Data Ecosystem
Most regulatory information management (RIM) systems were designed to capture ...
Connected Data, Interoperability Enable Greater Compliance and Beyond
Regulatory teams serve as the common thread of pharmaceutical research and development, connecting ...
