The Importance of Good Collaboration between Different Vendors to Ensure Compliance with Global and Local Regulations
In the realm of pharmaceuticals, regulatory compliance is paramount to ensure patient safety. With the complex environment of safety reporting, several vendors may be involved at global and local levels for performing submission activities to health authorities, ethics committees and investigators. Director of UBC Global Case Processing, Myrto Ioannidi and UBC Team Manager, Esther Aparicio review […]
DCTs: Beyond Hype and To a Hybrid Future
Clinical trials provide a limited view of patient experience but this can be expanded through tokenization to link pre- and post-trial data.
The Importance of Choosing the Right Pharmacovigilance Partner and Safety Physician
For most pharmaceutical companies, hiring a PV team will help alleviate some of the work of the existing internal team.
Putting the ‘Patient’ Back in Patient Services
Putting the patient back in patient services means we do more, go deeper, and customize offerings.
EMA/HMA Revised Guidance on Risk Minimization Measures
UBC is the leading provider of evidence development solutions with expertise in uniting evidence and access.
The Importance of Patient Choice
Providing the patient with choice throughout their journey empowers them to take an active role in therapy initiation and persistence.
Navigating Launch Readiness with FDA Negotiations
REMS readiness is a key component for certain drugs launch plans – are you on top of approval timelines and milestones and IT build needs?
ICH/FDA Draft Guidance on RWD Safety Studies Highlight Their Increased Importance
Understand the latest international opinion on the plan, design, and analysis of pharmacoepidemiological safety studies using RWD.
Enhance Your Pharmacovigilance and Regulatory Compliance with Expert PV System Transition Management and Seamless Migration
Whether your transition includes a vendor change, acquisition, or portfolio expansion, UBC makes it easy to transition your system.
RWD Enrichment Studies: Linking Pre- and Post-Trial Data Utilizing Tokenization
Clinical trials provide a limited view of patient experience but this can be expanded through tokenization to link pre- and post-trial data.
