DISCOVERY
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innovations during the drug
discovery phase.
Navigating the Path to FDA Approval: The Importance of a PDUFA Date
As a biopharmaceutical company advancing through the phases of clinical development, each ...
Moving Towards Sustainability in Clinical Research – Call to Action
The life sciences industry is becoming more focused on sustainability practices – a ...
Elevating Your Clinical Trial Audits with AI and Centralized Monitoring
This article is written by Elizabeth Bodi and Mike Lynch. Clinical trial audits serve as ...
Quality Governance and Evolution of Quality Management Review
Quality governance can be defined as an overarching framework that provides assurance of ...
Bringing In Vitro Diagnostics to Market with Real-World Evidence
In vitro diagnostic (IVD) devices are a unique type of medical device. Although they meet ...
Preparing Now for FDA START Program for Rare Disease Drug Developers
On September 29, 2023, the U.S. Food and Drug Administration (FDA) took action to help ...
In Memoriam: Laurie Halloran, BSN, MS, Visionary Leader, Passes Away
FOR IMMEDIATE RELEASE
Small Biotech and Pharma Dilemma – Three Steps to Remain Competitive on a Budget
While attending the annual SCOPE summit this year, listening to sessions and walking the ...
Pulling the Thread on FDA’s Master Protocol Draft Guidance
The U.S. Food and Drug Administration’s (FDA) draft guidance, Master Protocols for Drug ...
Clinical Trial Leadership: Enhancing Efficiencies and Reducing Risk
Read our latest Case Study Clinical Trial Leadership: Enhancing Efficiencies and Reducing ...