DISCOVERY
Uncover breakthrough
innovations during the drug
discovery phase.
innovations during the drug
discovery phase.
Should You Bring Your Trial Master File In-House?
This article is co-authored by Mike Lynch. A Trial Master File (TMF) is an ecosystem of ...
Successful Planning for an Original NDA / BLA Submission
This comprehensive webinar offers an insightful exploration into the intricate landscape ...
Critical Steps Towards a Collaborative Partnership and Governance Model
When crucial clinical trial activities are delegated by a sponsor to their vendor, the ...
The Vital Role of Collaboration and Leadership in Phase 2 Trials
In the intricate world of pharmaceutical development, the journey from a promising ...
Leveraging Outsourcing and Mixed Model Staffing Amid Layoffs
In the dynamic landscape of business, layoffs or losing momentum in a program with faulty ...
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 ...